NCT07435493

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 5 Years – 10 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-11-30
• Primary completion: 2026-11-30
• Completion: 2026-12-30
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: Egypt