About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Group A: Fentanyl-Based Analgesia
DrugFentanyl-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
DrugOpioid-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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Time to oral intake
Sponsors and contacts
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