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Fentanyl Versus Opioid Free Multimodal Analgesia for Perioperative Pain Control in Children With Mild to Moderate Obstructive Sleep Apnea

NCT07435493 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-02-27

No results posted yet for this study

Summary

Emphasize that the usage of multimodal analgesia in managing perioperative pain in children with mild to moderate Obstructive Sleep Apnea undergoing adenotonsillectomy may achieve the same efficacy of fentanyl with less respiratory complications and less opioid-related side effects.

Conditions

  • Adenotonsillectomy
  • Obstructive Sleep Apnea (OSA)
  • Fentanyl
  • Opioid

Interventions

DRUG

Group A: Fentanyl-Based Analgesia

Fentanyl-Based Analgesia will receive intraoperative fentanyl (1 μg/kg IV) with standard anesthetic care with postoperative rescue analgesia with acetaminophen (15 mg/kg) as needed

DRUG

Group B: Opioid-Free Multimodal Analgesia

Opioid-Free Multimodal Analgesia will receive preoperative acetaminophen (15 mg/kg) and ibuprofen (10 mg/kg), intraoperative ketamine (0.5 mg/kg IV) and dexamethasone (0.1 mg/kg IV) with postoperative rescue analgesia with acetaminophen as needed.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-30
Primary Completion
2026-11-30
Completion
2026-12-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07435493 on ClinicalTrials.gov