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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
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 sponsor | Thammasat University |
|---|---|
| Phase | NA |
| Status | NOT_YET_RECRUITING |
| Enrolment | 54 |
| Start date | 2026-03 |
| Completion | 2026-11 |
Conditions
- Post Operative Analgesia
- Tonsillectomy With or Without Adenoidectomy
Interventions
- Paracetamol (acetaminophen)
Primary outcomes
- Total postoperative opioid consumption — 0-12 hours after surgery
Total postoperative opioid consumption (expressed as cumulative IV fentanyl dose in mcg/kg) was administered.
Countries
Thailand