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

February 23, 2026 updated by: Anhar Fathy, Ain Shams University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Obstructive Sleep Apnea in pediatrics is a sleep disorder characterized by repeated episodes of partial or complete upper airway obstruction during sleep, leading to disrupted breathing, poor sleep quality, and potential developmental and health issues.

Since adeno-tonsillar hypertrophy and enlarged tonsils & adenoids are the most common causes of pediatric Obstructive Sleep Apnea ,thus adenotonsillectomy is the first-line surgical treatment and is one of the most common pediatric surgeries that has a high success rate in resolving Obstructive Sleep Apnea symptoms with cure rate up to 80%.

Adenotonsillectomy is a common surgical procedure in pediatric patients and perioperative pain management with opioids is common and associated with side effects and risks. Consequently, analgesic strategies to reduce opioid utilization have been developed, because Obstructive Sleep Apnea patients are more sensitive to opioids.

Fentanyl has demonstrated efficacy in pediatrics for acute pain management but still has the risk of opioids induced ventilatory impairment which is very common in children with obstructive sleep apnea due to altered volume of distribution and clearance.

A multimodal analgesia approach, which combines various non-opioid medications (acetaminophen, non-steroidal anti-inflammatory drugs, dexamethasone and ketamine ) can effectively manage perioperative pain in children with mild to moderate Obstructive Sleep Apnea with (apnea hypoxia index <or= 10) undergoing adenotonsillectomy, while minimizing the risks associated with opioid use.

The purpose of this study is to emphasize that the usage of multimodal analgesia in managing perioperative pain in children with mild to moderate OSA undergoing adenotonsillectomy may achieve the same efficacy of fentanyl with less respiratory complications and less opioid-related side effects.

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fentanyl-Based Analgesia group
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
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
Experimental: Opioid-Free Multimodal Analgesia group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FLACC Scale (face, legs, activity, cry, consolability)
Time Frame: at 0 hours, 2hours, and 6 hours postoperatively
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 Outcome Measures

Outcome Measure
Time Frame
Time to oral intake
Time Frame: 6 hours postoperatively
6 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 30, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

February 23, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MD141/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data ill be available when it needed

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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