Evaluation of the Postoperative Agitation Prevention and Analgesic Efficacy of Perioperative Dexmedetomidine Infusion in a Pediatric Patient Group to Undergo Tonsillectomy and Adenoidectomy
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| ClinicalTrials.gov Identifier: NCT05986942 |
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Recruitment Status :
Completed
First Posted : August 14, 2023
Last Update Posted : November 8, 2023
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Sponsor:
Burak Omur
Information provided by (Responsible Party):
Burak Omur, Medipol University
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Brief Summary:
Dexmedetomidine is a drug known for its pain-relieving and restlessness-reducing effects. The purpose of this run is to use the association between this use during surgery and the attrition of post-operative pain and discomfort. In the research, laboratory and monitoring results will be obtained before, during and after the operation. Postoperative patient complaints will be evaluated at the postoperative service visit. This study is decided on a completely voluntary basis.
| Condition or disease | Intervention/treatment |
|---|---|
| Anxiety Postoperative Pain Bleeding | Drug: Fentanyl Drug: Dexmedetomidine |
| Study Type : | Observational [Patient Registry] |
| Actual Enrollment : | 80 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 1 Day |
| Official Title: | Evaluation of the Postoperative Agitation Prevention and Analgesic Efficacy of Perioperative Dexmedetomidine Infusion in a Pediatric Patient Group to Undergo Tonsillectomy and Adenoidectomy |
| Actual Study Start Date : | October 9, 2023 |
| Actual Primary Completion Date : | November 7, 2023 |
| Actual Study Completion Date : | November 7, 2023 |
Resource links provided by the National Library of Medicine
| Group/Cohort | Intervention/treatment |
|---|---|
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Dex
patients using dexmedetomidine infusion
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Drug: Dexmedetomidine
In Group dex, dexmedetomidine infusion will be administered to the patient during the operation. Fentanyl bolus dose will be administered during anesthesia induction in group Fen.
Other Name: Precedex |
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Fen
patients using fentanyl for induction
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Drug: Fentanyl
In Group dex, dexmedetomidine infusion will be administered to the patient during the operation. Fentanyl bolus dose will be administered during anesthesia induction in group Fen.
Other Name: Talinat |
Primary Outcome Measures :
- postoperative pain [ Time Frame: Pain was evaluated at 0, 2, 4, 6 and 8 hours postoperatively. ]Postoperative pain level will be measured using the FLACC pain scale (face, legs, activity, cry, consolability). 4 and above will be considered as high pain level, below 4 as low pain level.
- postoperative anxiety [ Time Frame: anxiety was evaluated at 0, 2, 4, 6 and 8 hours postoperatively. ]Postoperative anxiety level will be measured using the Pediatric Anesthesia Emergence Delirium Scale (PAED). A value of 12 and above will be considered high anxiety, and values below 12 will be considered low anxiety.
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| Ages Eligible for Study: | 2 Years to 10 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients with ASA 1-2, aged 2-10 years, scheduled for elective tonsillectomy and/or adenoidectomy operation will be included
Criteria
Inclusion Criteria:
Patients with ASA 1-2, aged 2-10 years, scheduled for elective tonsillectomy and/or adenoidectomy operation will be included.
Exclusion Criteria:
developmental delay anxiety disorder Known history of allergy to alpha-2 agonistic agents use of antipsychotic medication beta blocker use of anticonvulsant drugs chronic pain syndrome with cardiac and craniofacial anomalies
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05986942
Locations
| Turkey | |
| Istanbul Medipol University | |
| Istanbul, Turkey | |
Sponsors and Collaborators
Burak Omur
Investigators
| Study Director: | Yaşar G Gül | Medipol University |
Publications of Results:
| Responsible Party: | Burak Omur, assistant professor, Medipol University |
| ClinicalTrials.gov Identifier: | NCT05986942 |
| Other Study ID Numbers: |
000030195314317 |
| First Posted: | August 14, 2023 Key Record Dates |
| Last Update Posted: | November 8, 2023 |
| Last Verified: | November 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Burak Omur, Medipol University:
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Dexmedetomidine tonsillectomy adenoidectomy postoperative anxiety |
Additional relevant MeSH terms:
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Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Fentanyl Dexmedetomidine Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics, Opioid Narcotics Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General Anesthetics |