Clinical Trial

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

Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07463482
Lead Sponsor Thammasat University
Conditions Post Operative Analgesia, Tonsillectomy With or Without Adenoidectomy
Enrollment 54 participants
Start Date 2026-03
Primary Completion 2026-09 (estimated)
Study Completion 2026-11 (estimated)
Updated on ClinicalTrials.gov 2026-03-11