Study of DA-9501 In Pediatric Subjects In The Intensive Care Unit

• ClinicalTrials.gov Identifier: NCT02757625
• Recruitment Status: Completed
• First Posted: May 2, 2016
• Results First Posted: December 17, 2018
• Last Update Posted: December 17, 2018
• Sponsor: Pfizer
• Collaborator: Maruishi Pharmaceutical
• Information provided by (Responsible Party): Pfizer

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: ICU Sedation
• Intervention: Drug: Dexmedetomidine hydrochloride
• Enrollment: 63

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years
Arm/Group Description	Participants with age between >=45 weeks corrected gestation age (CGA) to <12 months received 0.2 microgram per kilogram per hour (mcg/kg/h) of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Period Title: Overall Study
Started	14	18	19	12
Completed	14	18	17	12
Not Completed	0	0	2	0
Reason Not Completed
Investigator's discretion	0	0	1	0
Adverse Event	0	0	1	0

Baseline Characteristics

Arm/Group Title		Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Total
Arm/Group Description		Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Total of all reporting groups
Overall Number of Baseline Participants		14	18	19	12	63
Baseline Analysis Population Description		The Full Analysis Set (FAS) included all participants who have received at least one dose of the study drug.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Months
	Number Analyzed	14 participants	18 participants	19 participants	12 participants	63 participants
		6.1 (2.1)	16.9 (3.6)	45.7 (14.6)	112.1 (37.9)	41.3 (41.8)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	14 participants	18 participants	19 participants	12 participants	63 participants
	Female	8 57.1%	7 38.9%	7 36.8%	5 41.7%	27 42.9%
	Male	6 42.9%	11 61.1%	12 63.2%	7 58.3%	36 57.1%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	14 participants	18 participants	19 participants	12 participants	63 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	14 100.0%	18 100.0%	19 100.0%	12 100.0%	63 100.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	White	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Who Did Not Require a Rescue Sedative Within 24 Hours of Dosing of Study Drug
Description	Percentage of participants who did not require rescue medication for Sedation (Midazolam) based on the data of investigator's judgement and State Behavioral Scale (SBS) (which was a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation [placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs], the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation [removal of endotracheal tube], the target sedation depth was -1 to 0, where higher score indicated more responsive) were reported.
Time Frame	From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least one dose of the study drug.

Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
Arm/Group Description:	Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Number of Participants Analyzed	14	18	19	12	63
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	78.6; (51.7 to 93.2)	66.7; (43.6 to 83.9)	78.9; (56.1 to 92.0)	91.7; (62.5 to 100.0)	77.8; (66.0 to 86.4)

2. Secondary Outcome

Title	Percentage of Participants Who Did Not Require Administration of a Rescue Analgesic Within 24 Hours of Dosing of Study Drug
Description	Percentage of participants who did not require administration of a rescue analgesic (Fentanyl) in addition to administration of the study drug based on investigator's judgement were reported.
Time Frame	From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least one dose of the study drug.

Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
Arm/Group Description:	Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Number of Participants Analyzed	14	18	19	12	63
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	85.7; (58.8 to 97.2)	100.0; (79.3 to 100.0)	94.7; (73.5 to 100.0)	66.7; (38.8 to 86.4)	88.9; (78.5 to 94.8)

3. Secondary Outcome

Title	Total Amount of Rescue Sedative Administered Within 24 Hours of Dosing of Study Drug
Description	Total amount of rescue sedative (midazolam) administered Within 24 Hours of dosing of study drug.
Time Frame	From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)

Outcome Measure Data

Analysis Population Description

Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period).

Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
Arm/Group Description:	Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Number of Participants Analyzed	3	6	4	1	14
Mean (Standard Deviation); Unit of Measure: milligrams (mg)
	0.882 (0.8282)	3.188 (1.6935)	2.469 (1.3975)	1.960	2.401 (1.5793)

4. Secondary Outcome

Title	Body Weight Adjusted Total Amount (Per Kg) of Rescue Sedative Taken Within 24 Hours of Dosing of Study Drug
Description	Total amount of rescue sedative (midazolam) required within 24 hours of dosing of study drug. Dose was adjusted for body weight (mg divided by kg).
Time Frame	From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)

Outcome Measure Data

Analysis Population Description

Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period).

Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
Arm/Group Description:	Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Number of Participants Analyzed	3	6	4	1	14
Mean (Standard Deviation); Unit of Measure: mg/kg
	0.135 (0.1160)	0.353 (0.2219)	0.142 (0.0668)	0.100 (0)	0.228 (0.1866)

5. Secondary Outcome

Title	Total Amount of Rescue Analgesic Taken Within 24 Hours of Dosing of Study Drug
Description	Total amount of rescue sedative (fentanyl) required Within 24 Hours of dosing of study drug.
Time Frame	From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)

Outcome Measure Data

Analysis Population Description

Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period). Here "N" signifies number of participants who were evaluable for this specified outcome measure.

Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
Arm/Group Description:	Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Number of Participants Analyzed	2	0	1	4	7
Mean (Standard Deviation); Unit of Measure: micrograms
	91.70 (78.772)		97.50 (0)	81.74 (15.754)	86.84 (34.676)

6. Secondary Outcome

Title	Body Weight Adjusted Total Amount of Rescue Analgesic Taken Within 24 Hours of Dosing of Study Drug
Description	Total amount of rescue analgesic (fentanyl) within 24 Hours of dosing of study drug. Dose was adjusted for body weight (mcg divided by kg).
Time Frame	From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)

Outcome Measure Data

Analysis Population Description

Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period). Here "N" signifies number of participants who were evaluable for this specified outcome measure.

Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
Arm/Group Description:	Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Number of Participants Analyzed	2	0	1	4	7
Mean (Standard Deviation); Unit of Measure: mcg/kg
	15.00 (9.899)		5.00 (0)	3.78 (1.311)	7.16 (6.789)

7. Secondary Outcome

Title	Duration of Maintenance of Target Sedation Level Within 24 Hours of Dosing of Study Drug
Description	Time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the SBS. SBS was a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation (placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs), the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation (removal of endotracheal tube), the target sedation depth was -1 to 0, where higher score indicated more responsive.
Time Frame	From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least one dose of the study drug. Here "N" signifies number of participants who were evaluable for this specified outcome measure.

Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
Arm/Group Description:	Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Number of Participants Analyzed	13	17	19	11	60
Mean (Standard Deviation); Unit of Measure: hours
	7.95 (7.191)	3.89 (2.859)	3.52 (5.495)	2.96 (2.017)	4.50 (5.112)

8. Secondary Outcome

Title	Percentage of Maintenance Duration of Target Sedation Level Within 24 Hours of Dosing of Study Drug
Description	Percentage of time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument and it's score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= non-responsive. During intubation the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation, the target sedation depth was -1 to 0, where higher score indicated more responsive.
Time Frame	From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least one dose of the study drug. Here "N" signifies number of participants who were evaluable for this specified outcome measure.

Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
Arm/Group Description:	Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Number of Participants Analyzed	13	17	19	11	60
Mean (Standard Deviation); Unit of Measure: percentage of time
	54.08 (31.825)	60.97 (28.104)	50.54 (27.898)	62.25 (34.836)	56.54 (29.911)

9. Secondary Outcome

Title	Percentage of Participants Who Did Not Use a Rescue Sedative After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation
Description	Percentage of participants whose period of dosing of the investigational product exceeded 24 hours and who did not received rescue medication for Sedation (Midazolam) based on the data of investigator's judgement and SBS (which was a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation [placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs], the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation [removal of endotracheal tube], the target sedation depth was -1 to 0, where higher score indicated more responsive) were reported.
Time Frame	After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)

Outcome Measure Data

Analysis Population Description

Participants from FAS population whose period of dosing of investigational product exceeded 24 hours.

Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
Arm/Group Description:	Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Number of Participants Analyzed	2	0	1	0	3
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	100.0; (29.0 to 100.0)		100.0; (16.7 to 100.0)		100.0; (38.3 to 100.0)

10. Secondary Outcome

Title	Percentage of Participants Who Did Not Require Dosing of a Rescue Analgesic After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation
Description	Percentage of participants whose period of dosing of the investigational product exceeded 24 hours and who did not received rescue analgesic (Fentanyl) based on the investigator's judgement were reported.
Time Frame	After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)

Outcome Measure Data

Analysis Population Description

Participants from FAS population whose period of dosing of investigational product exceeded 24 hours.

Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
Arm/Group Description:	Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Number of Participants Analyzed	2	0	1	0	3
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	100.0; (29.0 to 100.0)		100.0; (16.7 to 100.0)		100.0; (38.3 to 100.0)

11. Secondary Outcome

Title	Total Amount of Rescue Sedative Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation
Description	Total amount of rescue sedative (midazolam) administered after 24 hours of dosing of study drug.
Time Frame	After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)

Outcome Measure Data

Analysis Population Description

Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period).

Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
Arm/Group Description:	Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Number of Participants Analyzed	0	0	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

12. Secondary Outcome

Title	Body Weight Adjusted Total Amount of Rescue Sedative Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation
Description	Total amount of rescue sedative (midazolam) required after 24 hours of dosing of study drug. Dose was adjusted for body weight (mg divided by kg).
Time Frame	After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)

Outcome Measure Data

Analysis Population Description

Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue sedative in the specified evaluation period).

Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
Arm/Group Description:	Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Number of Participants Analyzed	0	0	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

13. Secondary Outcome

Title	Total Amount of Rescue Analgesic Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation
Description	Total amount of rescue analgesic (Fentanyl) administered by the participants after 24 hours of dosing of study drug.
Time Frame	After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)

Outcome Measure Data

Analysis Population Description

Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period).

Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
Arm/Group Description:	Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Number of Participants Analyzed	0	0	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

14. Secondary Outcome

Title	Body Weight Adjusted Total Amount of Rescue Analgesic Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation
Description	Total amount of rescue analgesic (fentanyl) after 24 hours of dosing of study drug. Dose was adjusted for body weight (mcg divided by kg).
Time Frame	After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)

Outcome Measure Data

Analysis Population Description

Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period).

Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
Arm/Group Description:	Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Number of Participants Analyzed	0	0	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

15. Secondary Outcome

Title	Duration of Maintenance of Target Sedation Level After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation
Description	Time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation (placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs), the target sedation depth by SBS was -2 to 0, where higher score indicated more stability and after extubation (removal of endotracheal tube), the target sedation depth was -1 to 0, where higher score indicated more stability.
Time Frame	After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)

Outcome Measure Data

Analysis Population Description

Participants from FAS population whose period of dosing of investigational product exceeded 24 hours.

Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
Arm/Group Description:	Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Number of Participants Analyzed	2	0	1	0	3
Mean (Standard Deviation); Unit of Measure: hours
	0.81 (0.672)		0.92 (0)		0.84 (0.479)

16. Secondary Outcome

Title	Percentage of Maintenance Duration of Target Sedation Level After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation
Description	Percentage of time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument and it's score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= non-responsive. During intubation the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation, the target sedation depth was -1 to 0, where higher score indicated more responsive.
Time Frame	After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)

Outcome Measure Data

Analysis Population Description

Participants from FAS population whose period of dosing of investigational product exceeded 24 hours.

Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
Arm/Group Description:	Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Number of Participants Analyzed	2	0	1	0	3
Mean (Standard Deviation); Unit of Measure: percentage of time
	75.00 (35.355)		100.00 (0)		83.33 (28.868)

17. Secondary Outcome

Title	Duration of Maintenance of Target Sedation Level After Extubation
Description	Time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation (placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs), the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation (removal of endotracheal tube), the target sedation depth was -1 to 0, where higher score indicated more responsive.
Time Frame	From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days)

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least one dose of the study drug. Here "N" signifies number of participants who were evaluable for this specified outcome measure.

Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
Arm/Group Description:	Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Number of Participants Analyzed	14	18	16	10	58
Mean (Standard Deviation); Unit of Measure: hours
	11.68 (11.589)	7.73 (7.543)	7.60 (4.355)	6.73 (5.036)	8.42 (7.679)

18. Secondary Outcome

Title	Percentage of Maintenance Duration of Target Sedation Level After Extubation
Description	Percentage of time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument and it's score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= non-responsive. During intubation the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation, the target sedation depth was -1 to 0, where higher score indicated more responsive.
Time Frame	From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days)

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least one dose of the study drug. Here "N" signifies number of participants who were evaluable for this specified outcome measure.

Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
Arm/Group Description:	Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Number of Participants Analyzed	14	18	16	10	58
Mean (Standard Deviation); Unit of Measure: Percentage of time
	69.99 (28.260)	53.93 (28.613)	54.45 (30.805)	55.82 (41.195)	58.19 (31.829)

19. Secondary Outcome

Title	Total Amount of Rescue Sedative Taken After Extubation
Description	Total amount of rescue sedative (Midazolam) administered by the participants after extubation.
Time Frame	From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days)

Outcome Measure Data

Analysis Population Description

Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue sedative in the specified evaluation period). Here "N" signifies number of participants who were evaluable for this specified outcome measure.

Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
Arm/Group Description:	Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Number of Participants Analyzed	2	2	1	0	5
Mean (Standard Deviation); Unit of Measure: mg
	0.537 (0.3741)	0.719 (0.3379)	5.994		1.701 (2.4148)

20. Secondary Outcome

Title	Body Weight Adjusted Total Amount of Rescue Sedative Taken After Extubation
Description	Total amount of rescue sedative (midazolam) administered by the participants after extubation. Dose was adjusted for body weight (mg divided by kg).
Time Frame	From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days)

Outcome Measure Data

Analysis Population Description

Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue sedative in the specified evaluation period). Here "N" signifies number of participants who were evaluable for this specified outcome measure.

Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
Arm/Group Description:	Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Number of Participants Analyzed	2	2	1	0	5
Mean (Standard Deviation); Unit of Measure: mg/kg
	0.109 (0.0976)	0.072 (0.0304)	0.370		0.146 (0.1364)

21. Secondary Outcome

Title	Total Amount of Rescue Analgesic Taken After Extubation
Description	Total amount of rescue analgesic (fentanyl) administered by the participants after extubation.
Time Frame	From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days)

Outcome Measure Data

Analysis Population Description

Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue sedative in the specified evaluation period). Here "N" signifies number of participants who were evaluable for this specified outcome measure.

Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
Arm/Group Description:	Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Number of Participants Analyzed	0	0	1	0	1
Mean (Standard Deviation); Unit of Measure: mcg
			42.90		42.90

22. Secondary Outcome

Title	Body Weight Adjusted Total Amount of Rescue Analgesic Taken After Extubation
Description	Total amount of rescue analgesic (fentanyl) administered by the participants after extubation. Dose was adjusted for body weight (mcg divided by kg).
Time Frame	From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days)

Outcome Measure Data

Analysis Population Description

Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue sedative in the specified evaluation period). Here "N" signifies number of participants who were evaluable for this specified outcome measure.

Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
Arm/Group Description:	Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Number of Participants Analyzed	0	0	1	0	1
Mean (Standard Deviation); Unit of Measure: mcg/kg
			3.00		3.00

23. Secondary Outcome

Title	Median Time to Conclusion of Mechanical Ventilation
Description	Time to conclusion of mechanical ventilation was defined as time duration from start of study drug administration until the end of mechanical ventilation.
Time Frame	Baseline (start of study drug dosing) until end of mechanical ventilation (up to 28 days)

Outcome Measure Data

Analysis Population Description

FAS: all participants who received at least one dose of the investigational product.

Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
Arm/Group Description:	Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Number of Participants Analyzed	14	18	19	12	63
Median (Full Range); Unit of Measure: hours
	9.5; (6.3 to 17.5)	6.0; (4.6 to 6.3)	4.1; (3.0 to 6.0)	4.5; (3.8 to 6.0)	6.0; (4.8 to 6.2)

24. Other Pre-specified Outcome

Title	Number of Participants With Treatment- Emergent Adverse Events (AE) and Serious Adverse Events (SAE)
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to up to 28 days after end of study drug dosing (up to 56 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both non-serious adverse events (AEs) and SAEs.
Time Frame	Baseline up to 28 days after end of study drug dosing (up to 56 days)

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of the investigational product.

Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
Arm/Group Description:	Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Number of Participants Analyzed	14	18	19	12	63
Measure Type: Count of Participants; Unit of Measure: Participants
AEs	11 78.6%	16 88.9%	16 84.2%	12 100.0%	55 87.3%
SAEs	0 0.0%	0 0.0%	1 5.3%	0 0.0%	1 1.6%

25. Other Pre-specified Outcome

Title	Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Description	Vital signs included: systolic and diastolic blood pressure, heart rate, respiratory rate, percutaneous oxygen saturation, end-tidal carbon dioxide, core body temperature and body weight. Criteria for clinically significant vital signs abnormalities was based on Investigators decision.
Time Frame	Baseline up to 28 days after end of study drug dosing (Day 56)

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of the investigational product.

Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
Arm/Group Description:	Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Number of Participants Analyzed	14	18	19	12	63
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

26. Other Pre-specified Outcome

Title	Number of Participants With Laboratory Test Abnormalities
Description	Criteria for abnormality: hemoglobin, hematocrit and red blood cell count <0.8*lower limit of normal(LLN); platelet <0.5*LLN; >1.75*upper limit of normal(ULN); white blood cell count <0.6*LLN; >1.5*ULN; lymphocytes, neutrophils and stab cells <0.8*LLN; >1.2*ULN; eosinophils, basophils and monocytes >1.2*ULN; total bilirubin >1.5*ULN; aspartate aminotransferase, alanine aminotransferase and gamma guanosine triphosphate and alkaline phosphatase >3*ULN; total protein and albumin <0.8*LLN; >1.2*ULN; glucose <0.6*LLN; >1.5*ULN; blood urea nitrogen and creatinine >1.3*ULN; uric acid >1.2*ULN; sodium <0.95*LLN; >1.05*ULN, potassium, calcium and magnesium <0.9*LLN; >1.1*ULN; phosphate <0.8*LLN; >1.2*ULN.
Time Frame	Baseline up to 28 days after end of study drug dosing (Day 56)

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of the investigational product. Here "N" signifies number of participants who were evaluable for this specified outcome measure.

Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
Arm/Group Description:	Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Number of Participants Analyzed	14	18	18	12	62
Measure Type: Count of Participants; Unit of Measure: Participants
	13 92.9%	18 100.0%	15 83.3%	11 91.7%	57 91.9%

27. Other Pre-specified Outcome

Title	Total Input/Output Fluid Volume
Description	Total input fluid volume was defined as the quantity of total fluids administered and total output fluid volume was defined as the quantity of total fluids excreted or lost during the specified evaluation period.
Time Frame	Baseline up to 28 days after end of study drug dosing (Day 56)

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of the investigational product. Here "N" signifies number of participants who were evaluable for this specified outcome measure.

Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
Arm/Group Description:	Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Number of Participants Analyzed	14	18	18	12	63
Mean (Standard Deviation); Unit of Measure: milliliters (mL)
Input Volume	779.39 (342.617)	799.18 (356.254)	1023.60 (337.825)	1415.96 (822.212)	979.24 (520.514)
Output Volume	975.06 (436.904)	801.53 (353.379)	1041.80 (356.375)	1313.58 (625.474)	1009.58 (461.471)

28. Other Pre-specified Outcome

Title	Incidence of Potential Withdrawal Symptoms
Description	The potential withdrawal symptoms were defined as AEs that occurred or worsened after end of administration of dexmedetomidine. It included bradycardia, abdominal discomfort, abdominal pain, dry mouth, nausea, vomiting, injection site pain, pyrexia, body temperature increased, electrocardiogram QT prolonged, neuralgia, agitation, atelectasis, oropharyngeal pain and hypotension. Incidence of potential withdrawal symptoms was reported in terms of number of participants who had any of the mentioned withdrawal symptoms.
Time Frame	Baseline up to 28 days after end of study drug dosing (Day 56)

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of the investigational product.

Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
Arm/Group Description:	Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Number of Participants Analyzed	14	18	19	12	63
Measure Type: Count of Participants; Unit of Measure: Participants
Bradycardia	0 0.0%	4 22.2%	0 0.0%	0 0.0%	4 6.3%
Abdominal discomfort	0 0.0%	0 0.0%	1 5.3%	0 0.0%	1 1.6%
Abdominal pain	0 0.0%	0 0.0%	0 0.0%	1 8.3%	1 1.6%
Dry mouth	0 0.0%	0 0.0%	1 5.3%	0 0.0%	1 1.6%
Nausea	0 0.0%	0 0.0%	2 10.5%	3 25.0%	5 7.9%
Vomiting	1 7.1%	1 5.6%	1 5.3%	4 33.3%	7 11.1%
Injection site pain	0 0.0%	0 0.0%	0 0.0%	1 8.3%	1 1.6%
Pyrexia	1 7.1%	0 0.0%	0 0.0%	0 0.0%	1 1.6%
Body temperature increased	1 7.1%	0 0.0%	0 0.0%	0 0.0%	1 1.6%
Electrocardiogram QT prolonged	0 0.0%	0 0.0%	1 5.3%	0 0.0%	1 1.6%
Neuralgia	0 0.0%	0 0.0%	0 0.0%	1 8.3%	1 1.6%
Agitation	1 7.1%	1 5.6%	1 5.3%	0 0.0%	3 4.8%
Atelectasis	1 7.1%	1 5.6%	0 0.0%	0 0.0%	2 3.2%
Oropharyngeal pain	0 0.0%	0 0.0%	0 0.0%	1 8.3%	1 1.6%
Hypotension	0 0.0%	1 5.6%	1 5.3%	1 8.3%	3 4.8%

29. Other Pre-specified Outcome

Title	Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Description	Criteria for clinically significant electrocardiogram abnormalities was based on Investigators decision.
Time Frame	Baseline up to 28 days after end of study drug dosing (Day 56)

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least one dose of the investigational product. Here "N" signifies number of participants who were evaluable for this specified outcome measure.

Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
Arm/Group Description:	Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Number of Participants Analyzed	14	18	19	12	63
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

Adverse Events

Time Frame	Baseline up to 28 days after end of study drug dosing (Day 56)
Adverse Event Reporting Description	Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Arm/Group Title	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
Arm/Group Description	Participants with age between >=45 weeks CGA to <12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=12 months to <24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=2 years to <6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=6 years to <17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Participants with age between >=45 weeks CGA to <17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
All-Cause Mortality
	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/14 (0.00%)	0/18 (0.00%)	0/19 (0.00%)	0/12 (0.00%)	0/63 (0.00%)
Serious Adverse Events
	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/14 (0.00%)	0/18 (0.00%)	1/19 (5.26%)	0/12 (0.00%)	1/63 (1.59%)
Cardiac disorders
Cardiac tamponade * 1	0/14 (0.00%)	0/18 (0.00%)	1/19 (5.26%)	0/12 (0.00%)	1/63 (1.59%)
1 Term from vocabulary, MedDRA 20.0; * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Dexmedetomidine: >=45 Weeks CGA to <12 Months	Dexmedetomidine: >=12 Months to <24 Months	Dexmedetomidine: >=2 Years to <6 Years	Dexmedetomidine: >=6 Years to <17 Years	Dexmedetomidine: All Participants
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	11/14 (78.57%)	16/18 (88.89%)	16/19 (84.21%)	12/12 (100.00%)	55/63 (87.30%)
Blood and lymphatic system disorders
Iron deficiency anaemia * 1	0/14 (0.00%)	1/18 (5.56%)	1/19 (5.26%)	0/12 (0.00%)	2/63 (3.17%)
Cardiac disorders
Bradycardia * 1	6/14 (42.86%)	7/18 (38.89%)	5/19 (26.32%)	2/12 (16.67%)	20/63 (31.75%)
Gastrointestinal disorders
Abdominal discomfort * 1	0/14 (0.00%)	0/18 (0.00%)	1/19 (5.26%)	0/12 (0.00%)	1/63 (1.59%)
Abdominal pain * 1	0/14 (0.00%)	0/18 (0.00%)	0/19 (0.00%)	1/12 (8.33%)	1/63 (1.59%)
Dry mouth * 1	0/14 (0.00%)	0/18 (0.00%)	1/19 (5.26%)	0/12 (0.00%)	1/63 (1.59%)
Gastric mucosal lesion * 1	0/14 (0.00%)	0/18 (0.00%)	1/19 (5.26%)	0/12 (0.00%)	1/63 (1.59%)
Mouth ulceration * 1	0/14 (0.00%)	1/18 (5.56%)	0/19 (0.00%)	0/12 (0.00%)	1/63 (1.59%)
Vomiting * 1	1/14 (7.14%)	1/18 (5.56%)	2/19 (10.53%)	5/12 (41.67%)	9/63 (14.29%)
Nausea * 1	0/14 (0.00%)	0/18 (0.00%)	2/19 (10.53%)	5/12 (41.67%)	7/63 (11.11%)
General disorders
Injection site pain * 1	0/14 (0.00%)	0/18 (0.00%)	0/19 (0.00%)	1/12 (8.33%)	1/63 (1.59%)
Pyrexia * 1	1/14 (7.14%)	2/18 (11.11%)	1/19 (5.26%)	2/12 (16.67%)	6/63 (9.52%)
Infections and infestations
Pneumonia * 1	0/14 (0.00%)	0/18 (0.00%)	1/19 (5.26%)	0/12 (0.00%)	1/63 (1.59%)
Injury, poisoning and procedural complications
Postoperative fever * 1	0/14 (0.00%)	0/18 (0.00%)	1/19 (5.26%)	0/12 (0.00%)	1/63 (1.59%)
Investigations
Body temperature increased * 1	1/14 (7.14%)	2/18 (11.11%)	0/19 (0.00%)	0/12 (0.00%)	3/63 (4.76%)
Electrocardiogram QT prolonged * 1	0/14 (0.00%)	0/18 (0.00%)	1/19 (5.26%)	0/12 (0.00%)	1/63 (1.59%)
Metabolism and nutrition disorders
Acidosis * 1	0/14 (0.00%)	0/18 (0.00%)	1/19 (5.26%)	0/12 (0.00%)	1/63 (1.59%)
Nervous system disorders
Headache * 1	0/14 (0.00%)	0/18 (0.00%)	0/19 (0.00%)	1/12 (8.33%)	1/63 (1.59%)
Neuralgia * 1	0/14 (0.00%)	0/18 (0.00%)	0/19 (0.00%)	1/12 (8.33%)	1/63 (1.59%)
Psychiatric disorders
Agitation * 1	4/14 (28.57%)	2/18 (11.11%)	1/19 (5.26%)	0/12 (0.00%)	7/63 (11.11%)
Renal and urinary disorders
Acute kidney injury * 1	0/14 (0.00%)	0/18 (0.00%)	1/19 (5.26%)	0/12 (0.00%)	1/63 (1.59%)
Respiratory, thoracic and mediastinal disorders
Atelectasis * 1	1/14 (7.14%)	1/18 (5.56%)	0/19 (0.00%)	0/12 (0.00%)	2/63 (3.17%)
Hypoxia * 1	1/14 (7.14%)	0/18 (0.00%)	0/19 (0.00%)	0/12 (0.00%)	1/63 (1.59%)
Laryngeal oedema * 1	0/14 (0.00%)	1/18 (5.56%)	0/19 (0.00%)	0/12 (0.00%)	1/63 (1.59%)
Oropharyngeal pain * 1	0/14 (0.00%)	0/18 (0.00%)	0/19 (0.00%)	1/12 (8.33%)	1/63 (1.59%)
Pleural effusion * 1	0/14 (0.00%)	1/18 (5.56%)	0/19 (0.00%)	0/12 (0.00%)	1/63 (1.59%)
Respiratory depression * 1	2/14 (14.29%)	7/18 (38.89%)	3/19 (15.79%)	5/12 (41.67%)	17/63 (26.98%)
Respiratory disorder * 1	0/14 (0.00%)	0/18 (0.00%)	0/19 (0.00%)	1/12 (8.33%)	1/63 (1.59%)
Respiratory tract oedema * 1	1/14 (7.14%)	1/18 (5.56%)	1/19 (5.26%)	0/12 (0.00%)	3/63 (4.76%)
Skin and subcutaneous tissue disorders
Decubitus ulcer * 1	0/14 (0.00%)	1/18 (5.56%)	0/19 (0.00%)	0/12 (0.00%)	1/63 (1.59%)
Erythema * 1	1/14 (7.14%)	0/18 (0.00%)	0/19 (0.00%)	0/12 (0.00%)	1/63 (1.59%)
Vascular disorders
Hypertension * 1	0/14 (0.00%)	0/18 (0.00%)	0/19 (0.00%)	1/12 (8.33%)	1/63 (1.59%)
Hypotension * 1	3/14 (21.43%)	8/18 (44.44%)	11/19 (57.89%)	9/12 (75.00%)	31/63 (49.21%)
1 Term from vocabulary, MedDRA 20.0; * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

• Name/Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.
• Phone: 1-800-718-1021
• EMail: ClinicalTrials.gov_Inquiries@pfizer.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Takeuchi M, Nemoto S, Suzuki Y, Takahashi N, Takenaka N, Takata A, Kobayashi M. Age-Specific Dose Regimens of Dexmedetomidine for Pediatric Patients in Intensive Care Following Elective Surgery: A Phase 3, Multicenter, Open-Label Clinical Trial in Japan. Pediatr Crit Care Med. 2021 Nov 1;22(11):e546-e557. doi: 10.1097/PCC.0000000000002730.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02757625
• Other Study ID Numbers: C0801017; ZIN-DEX-1506 ( Other Identifier: Alias Study Number )
• First Submitted: April 11, 2016
• First Posted: May 2, 2016
• Results First Submitted: May 16, 2018
• Results First Posted: December 17, 2018
• Last Update Posted: December 17, 2018