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Effect of Preoperative Oral Paracetamol Loading Dose Versus Standard Dose on Postoperative Opioid Consumption in Pediatric Tonsillectomy With Multimodal Analgesia: A Randomized Controlled Trial

NCT07463482 NA NOT_YET_RECRUITING

This randomized clinical trial compares two different preoperative doses of oral paracetamol (acetaminophen) in children undergoing elective tonsillectomy. The aim is to determine whether a higher loading dose (30 mg/kg) decreases the need for opioid rescue medication after surgery compared with the standard dose (15 mg/kg), when used as part of a multimodal pain management approach. Children aged 3 to 15 years will be randomly assigned to receive either 30 mg/kg or 15 mg/kg of oral paracetamol before surgery. All participants will receive the same standard anesthesia and postoperative pain management. The primary outcome is the total amount of rescue opioid (fentanyl) required during the first 12 hours after surgery. Secondary outcomes include postoperative pain scores and the occurrence of side effects such as nausea and vomiting. This study seeks to determine whether a higher initial dose of paracetamol offers additional clinical benefits in pediatric tonsillectomy with multimodal analgesia.

Details

Lead sponsorThammasat University
PhaseNA
StatusNOT_YET_RECRUITING
Enrolment54
Start date2026-03
Completion2026-11

Conditions

Interventions

Primary outcomes

Countries

Thailand