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Preoperative High-Dose Oral Paracetamol for Postoperative Analgesia in Children Undergoing Tonsillectomy"
Sponsor: Thammasat University
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
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