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

NCT07435493 | Not Yet Recruiting

• 1 other identifier: FMASU MD141/2025
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

opioid; Fentanyl; obstructive sleep apnea; adenotonsillectomy

Outcome Measures

Primary Outcomes (1)

• FLACC Scale (face, legs, activity, cry, consolability)

  It grades pain from 0 to 10 by observing five categories-Face, Legs, Activity, Cry, and Consolability-with each item scored 0-2.

  at 0 hours, 2hours, and 6 hours postoperatively

Secondary Outcomes (1)

• Time to oral intake

  6 hours postoperatively

Study Arms (2)

Fentanyl-Based Analgesia group

EXPERIMENTAL

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 A: Fentanyl-Based Analgesia

Opioid-Free Multimodal Analgesia group

EXPERIMENTAL

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.

Drug: Group B: Opioid-Free Multimodal Analgesia

Interventions

Group A: Fentanyl-Based Analgesia DRUG

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

Fentanyl-Based Analgesia group

Group B: Opioid-Free Multimodal Analgesia DRUG

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.

Opioid-Free Multimodal Analgesia group

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 5-10 years.
• Diagnosed with mild to moderate Obstructive Sleep Apnea (apnea-hypoxia index 1-10).
• Scheduled for elective adenotonsillectomy.
• American Society of Anesthesiologists physical status I-II.

You may not qualify if:

• Severe Obstructive Sleep Apnea (apnea-hypoxia index \>10).
• Known allergies to study medications.
• Patient with predicted difficult air way (Mallampatti 3\&4).
• History of opioid use or chronic pain syndromes.
• Neurological or metabolic disorders affecting pain perception.
• Parental refusal to consent.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, Egypt

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Anhar Falila, Assistant Lecturer

CONTACT

01222176925; Anhar.fathy@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in anesthesiology, faculty of medicine, Ain shams university

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 27, 2026
• Study Start (Estimated): November 30, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

EG (1)