Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery

• ClinicalTrials.gov Identifier: NCT04230681
• Recruitment Status: Completed
• First Posted: January 18, 2020
• Last Update Posted: March 2, 2023
• Sponsor: Washington University School of Medicine
• Information provided by (Responsible Party): Washington University School of Medicine

Study Description

Brief Summary:

A RCT to compare hydromorphone versus fentanyl for pain control following tonsillectomy or adenotonsillectomy surgery.

Condition or disease	Intervention/treatment	Phase
Obstructive Sleep Apnea; Tonsillitis	Drug: Hydromorphone; Drug: Fentanyl	Early Phase 1

Detailed Description:

This is a randomized clinical trial with masked assessment, comparing recovery indices for patients receiving intermediate acting versus short acting opioid analgesia using hydromorphone or fentanyl as intraoperative analgesics. An otherwise standardized anesthetic and analgesic regimen will be utilized, consistent with routine care at SLCH. Patients will be randomized 1:1 in block sizes of 5 per group. Patients will be randomized to receive either hydromorphone or fentanyl throughout the perioperative period by opening a sealed protocol envelope.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 189 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial to Compare Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery
• Actual Study Start Date: February 26, 2020
• Actual Primary Completion Date: April 1, 2022
• Actual Study Completion Date: April 1, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Fentanyl	Drug: Fentanyl; Fentanyl
Active Comparator: Hydromorphone	Drug: Hydromorphone; Patients will be randomized to one of two opioids for the treatment of post-operative pain.

Outcome Measures

Primary Outcome Measures :

1. Amount of rescue opioid medications administered - hydromorphone group [ Time Frame: up to 48 hours post surgery ]
   Postoperative opioid medication expressed in morphine equivalents
2. Amount of rescue opioid medications administered - fentanyl group [ Time Frame: up to 48 hours post surgery ]
   Postoperative opioid medication expressed in morphine equivalents
3. Evaluation of participant's pain - hydromorphone group [ Time Frame: up to 48 hours post surgery ]
   Revised Face, Legs, Activity, Cry, Consolability (rFLACC) Scale Each of the five categories (F) Face; (L) Legs; (A) Activity; (C) Cry; (C) Consolability is scored from 0-2, which results in a total score between zero and ten. 0=no pain/relaxed, 10=distressed/in pain
4. Evaluation of participant's pain - fentanyl group [ Time Frame: up to 48 hours post surgery ]
   Revised Face, Legs, Activity, Cry, Consolability (rFLACC) Scale Each of the five categories (F) Face; (L) Legs; (A) Activity; (C) Cry; (C) Consolability is scored from 0-2, which results in a total score between zero and ten. 0=no pain/relaxed, 10=distressed/in pain

Secondary Outcome Measures :

1. Preoperative Amsterdam Preoperative Anxiety Scale - hydromorphone group [ Time Frame: up to 12 hours prior to surgery ]

   Caregiver of the participant is asked questions regarding the child's anxiety level prior to surgery. The questions asked: 1) I am worried about the anesthetic, 2) The anesthetic is on my mind continually, 3) I would like to know as much as possible about the anesthetic, 4) I am worried about the procedure, 5) The procedure is on my mind continually, 6) I would like to know as much as possible about the procedure

   The measure of agreement with these statements should be graded on a 5-point Likert scale from 1 "not at all" to 5 "extremely." A score of ≥11 identify anxious patients in clinical practice.

2. Preoperative Amsterdam Preoperative Anxiety Scale - fentanyl group [ Time Frame: up to 12 hours prior to surgery ]

   Caregiver of the participant is asked questions regarding the child's anxiety level prior to surgery. The questions asked: 1) I am worried about the anesthetic, 2) The anesthetic is on my mind continually, 3) I would like to know as much as possible about the anesthetic, 4) I am worried about the procedure, 5) The procedure is on my mind continually, 6) I would like to know as much as possible about the procedure

   The measure of agreement with these statements should be graded on a 5-point Likert scale from 1 "not at all" to 5 "extremely." A score of ≥11 identify anxious patients in clinical practice.

3. Yale Preoperative Anxiety Scale - hydromorphone group [ Time Frame: up to 12 hours prior to surgery ]
   Assessing child anxiety during the induction of anesthesia. It contains 22 items in 5 categories: activity, emotional expressivity, state of arousal, vocalization, and use of parents. Each category receives a score on a scale of 0 to 4 (6 for vocalization) according to the behavior of the patient, with 0 = no anxiety and 4 (or 6 for vocalization) = high anxiety.
4. Yale Preoperative Anxiety Scale - fentanyl group [ Time Frame: up to 12 hours prior to surgery ]
   Assessing child anxiety during the induction of anesthesia. It contains 22 items in 5 categories: activity, emotional expressivity, state of arousal, vocalization, and use of parents. Each category receives a score on a scale of 0 to 4 (6 for vocalization) according to the behavior of the patient, with 0 = no anxiety and 4 (or 6 for vocalization) = high anxiety.
5. ASA physical status classification score from preoperative assessment - hydromorphone group [ Time Frame: up to 12 hours prior to surgery ]
   ASA I A normal healthy patient ASA II A patient with mild systemic disease ASA III A patient with severe systemic disease ASA IV A patient with severe systemic disease that is a constant threat to life ASA V A moribund patient who is not expected to survive without the operation ASA VI A declared brain-dead patient whose organs are being removed for donor purposes
6. ASA physical status classification score from preoperative assessment - fentanyl group [ Time Frame: up to 12 hours prior to surgery ]
   ASA I A normal healthy patient ASA II A patient with mild systemic disease ASA III A patient with severe systemic disease ASA IV A patient with severe systemic disease that is a constant threat to life ASA V A moribund patient who is not expected to survive without the operation ASA VI A declared brain-dead patient whose organs are being removed for donor purposes
7. Optional opioid plasma concentrations - hydromorphone group [ Time Frame: up to 48 hours after surgery ]
   Blood collection at three time points using mass spectroscopy (This is optional for participants)
8. Optional opioid plasma concentrations - fentanyl group [ Time Frame: up to 48 hours after surgery ]
   Blood collection at three time points using mass spectroscopy (This is optional for participants)
9. Adverse events - hydromorphone group [ Time Frame: up to 48 hours after surgery ]
   Nausea/vomiting, witnessed apneic events, desaturation events, respiratory depression, re-intubation, decreased oxygen saturation
10. Adverse events - fentanyl group [ Time Frame: up to 48 hours after surgery ]
    Nausea/vomiting, witnessed apneic events, desaturation events, respiratory depression, re-intubation, decreased oxygen saturation
11. NIH PROMIS - hydromorphone group [ Time Frame: up to 48 hours after surgery ]
    Patient satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always
12. NIH PROMIS - fentanyl group [ Time Frame: up to 48 hours after surgery ]
    Patient satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always
13. NIH PROMIS - hydromorphone group [ Time Frame: up to 48 hours after surgery ]
    Patient caregiver satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always
14. NIH PROMIS - fentanyl group [ Time Frame: up to 48 hours after surgery ]
    Patient caregiver satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always
15. Child Hospital Survey (CAHPS) - hydromorphone group [ Time Frame: up to 48 hours after surgery ]
    Patient caregiver satisfaction. Scale of 1 - 4 with 1=never and 6=always
16. Child Hospital Survey (CAHPS) - fentanyl group [ Time Frame: up to 48 hours after surgery ]
    Patient caregiver satisfaction. Scale of 1 - 4 with 1=never and 6=always

Eligibility Criteria

• Ages Eligible for Study: 2 Years to 15 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Children ages 2 to 15 years old
2. Presenting for tonsillectomy or adenotonsillectomy surgery
3. American Society of Anesthesiologists Physical Status (ASAPS) Classification 1, 2 or 3
4. Provide Informed Consent / Assent (as appropriate)

Exclusion Criteria:

1. Additional Concurrent surgeries, exclusive of myringotomy tubes, minor oral/nasal procedures (e.g. frenulectomy), and endoscopic procedures
2. Revision tonsillectomy or revision adenotonsillectomy surgery
3. Known pregnancy
4. Any condition which would make the participant, in the opinion of the investigator or the attending anesthesiologist caring for the patient, unsuitable for the study.

Contacts and Locations

Locations

United States, Missouri

Washington University School of Medicine/Barnes-Jewish Hospital

Saint Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

Investigators

• Principal Investigator: Michael Montana, MD PhD; Washington University School of Medicine

  Study Documents (Full-Text)

Documents provided by Washington University School of Medicine:

Informed Consent Form  [PDF] November 16, 2021

More Information

Publications:

Friedman NR, Perkins JN, McNair B, Mitchell RB. Current practice patterns for sleep-disordered breathing in children. Laryngoscope. 2013 Apr;123(4):1055-8. doi: 10.1002/lary.23709. Epub 2013 Feb 4.

Brown KA. Outcome, risk, and error and the child with obstructive sleep apnea. Paediatr Anaesth. 2011 Jul;21(7):771-80. doi: 10.1111/j.1460-9592.2011.03597.x. Epub 2011 May 3.

Bhattacharyya N, Lin HW. Changes and consistencies in the epidemiology of pediatric adenotonsillar surgery, 1996-2006. Otolaryngol Head Neck Surg. 2010 Nov;143(5):680-4. doi: 10.1016/j.otohns.2010.06.918.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT04230681
• Other Study ID Numbers: 201912042
• First Posted: January 18, 2020
• Last Update Posted: March 2, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Tonsillitis; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Fentanyl; Hydromorphone; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Anesthetics