drugset / Trial / NCT07463482

Preoperative High-Dose Oral Paracetamol for Postoperative Analgesia in Children Undergoing Tonsillectomy"

NCT07463482

Not yet recruiting 54 enrolled Thammasat University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2026-03
Primary completion
2026-09
Completion
2026-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 15 mg/kg Oral
Subject Acetaminophen Small molecule 30 mg/kg Oral

Indications

No indication recorded.