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

NCT07463482 | Not Yet Recruiting DMC

• 1 other identifier: MTU-EC-AN-0-306/68
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post Operative Analgesia; Tonsillectomy With or Without Adenoidectomy

Keywords

paracetamol; acetaminophen; tonsillectomy; postoperative analgesia; pediatric anesthesia; multimodal analgesia

Outcome Measures

Primary Outcomes (1)

• Total postoperative opioid consumption

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

  0-12 hours after surgery

Study Arms (2)

High-dose oral paracetamol (30 mg/kg)

EXPERIMENTAL

Participants receive oral paracetamol 30 mg/kg approximately 30-60 minutes before surgery.

Drug: Paracetamol (acetaminophen)

Standard-dose oral paracetamol (15 mg/kg)

ACTIVE COMPARATOR

Participants receive oral paracetamol 15 mg/kg approximately 30-60 minutes before surgery.

Drug: Paracetamol (acetaminophen)

Interventions

Paracetamol (acetaminophen) DRUG

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

High-dose oral paracetamol (30 mg/kg); Standard-dose oral paracetamol (15 mg/kg)

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 3 to 15 years
• ASA physical status I-III
• Scheduled for elective tonsillectomy with or without adenoidectomy

You may not qualify if:

• Known allergy or contraindication to paracetamol or any agents in the study protocol
• Chronic opioid use

Sponsors & Collaborators

• Thammasat University: lead

Study Sites (1)

Thammasat University

Pathum Thani, Changwat Pathum Thani, 12120, Thailand

Location

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Waranya Lertpaitoonpan, MD

CONTACT

+66892039291; waranya.anesthtu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty of Medicine, Thammasat University

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 11, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)