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NCT Number: NCT07435493

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

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.

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Key information

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Time to oral intake

    Time frame: 6 hours postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

Anhar Falila, Assistant Lecturer

CONTACT

[email protected]

01222176925

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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