Maxigesic Oral Suspension for Children undergoing Tonsillectomy

Phase 2

Completed

• Conditions: Post Tonsillectomy Pain Relief; Anaesthesiology - Pain management; Surgery - Other surgery

• Registration Number: ACTRN12615000456550
• Lead Sponsor: AFT pharmaceuticals Ltd

Brief Summary

This fixed dose combination (paracetamol 32 mg/mL + ibuprofen 9.6 mg/mL oral suspension) is safe to provide comparable pain relief at two different dose regimen ((Higher dose: paracetamol 15 mg/kg + ibuprofen 4.5 mg/kg, Lower dose: paracetamol 12 mg/kg + ibuprofen 3.6 mg/kg) among children aged from 2-12 years old following their tonsillectomy surgery.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-11
• Study Completion: 2017-05-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 253

Inclusion Criteria

Children aged 2-12 yrs of age
Scheduled to undergo tonsillectomy with or without adenoidectomy
Written informed consent from parents/legal guardians and assent from participant (where appropriate).

Exclusion Criteria

Participants declines assent (or consent) or parent declines consent
Two small (weight<10kg at baseline)
Having taken any NSAID or paracetamol within 12hrs prior to the surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified