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

NCT07463482 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-03-11

No results posted yet for this study

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

Interventions

DRUG

Paracetamol (acetaminophen)

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

Sponsors & Collaborators

  • Thammasat University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2026-09-30
Completion
2026-11-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07463482 on ClinicalTrials.gov