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NOT YET RECRUITING
NCT07463482
NA

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

Sponsor: Thammasat University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

3 Years - 15 Years

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2026-03

Completion Date

2026-11

Last Updated

2026-03-11

Healthy Volunteers

No

Interventions

DRUG

Paracetamol (acetaminophen)

Oral paracetamol administered preoperatively as a single dose ( 15 mg/kg or 30 mg/kg, depending on assigned arm).

Locations (1)

Thammasat University

Pathum Thani, Changwat Pathum Thani, Thailand