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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-15
SponsorThammasat University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Paracetamol (acetaminophen)

    Drug

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

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: High-dose oral paracetamol (30 mg/kg)Experimental treatment 1 intervention
Group B: Standard-dose oral paracetamol (15 mg/kg)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total postoperative opioid consumption

Total postoperative opioid consumption (expressed as cumulative IV fentanyl dose in mcg/kg) was administered.

Time frame
0-12 hours after surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: