About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged 3 to 15 years
ASA physical status I-III
Scheduled for elective tonsillectomy with or without adenoidectomy
Disqualifiers
Known allergy or contraindication to paracetamol or any agents in the study protocol
Chronic opioid use
Trial design
Parallel
Treatments tested in this trial
Paracetamol (acetaminophen)
DrugOral paracetamol administered preoperatively as a single dose ( 15 mg/kg or 30 mg/kg, depending on assigned arm).
Treatment groups
Trial outcomes
Primary outcomes
Total postoperative opioid consumption
Total postoperative opioid consumption (expressed as cumulative IV fentanyl dose in mcg/kg) was administered.
Sponsors and contacts
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