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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.
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.
Age
5 - 10 years
Sex
ALL
Healthy Volunteers
No
Ain shams university
Cairo, Egypt
Start Date
November 30, 2026
Primary Completion Date
November 30, 2026
Completion Date
December 30, 2026
Last Updated
February 27, 2026
64
ESTIMATED participants
Group A: Fentanyl-Based Analgesia
DRUG
Group B: Opioid-Free Multimodal Analgesia
DRUG
Lead Sponsor
Ain Shams University
NCT07292922
NCT06838260
NCT06861686
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