Maxi-Analgesic Junior Study

Phase 3

Completed

• Conditions: Children requiring analgesia post tonsillectomy; Surgery - Pain management

• Registration Number: ACTRN12607000005459
• Lead Sponsor: Hartley Atkinson, Managing Director, AFT Pharmaceuticals, Ltd

Brief Summary

This fixed dose combination of ibuprofen and acetaminophen (acetaminophen 120 mg + ibuprofen 60 mg per 5 mL oral suspension) was not superior to its individual components in the regimen studied in this pediatric population undergoing tonsillectomy

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-04
• Study Completion: 2010-06-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

Children requiring analgesia post tonsillectomy.

Exclusion Criteria

Too young or too old.Too small (weight below 15 kg at base line visit)Having taken any NSAID or paracetamol within 12 hours prior to the operation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the analgesic effects of the 3 treatment groups (paracetamol+ibuprofen, paracetamol or ibuprofen) on the time adjusted AUC (Area under the curve) of the VAS (Visual Analogue Scale) pain scores[Taken at rest from the first dose of study medication until 48 hours after the first dose.]

Secondary Outcome Measures

Name	Time	Method
To compare the analgesic effects of the 3 treatment groups (paracetamol+ibuprofen, paracetamol or ibuprofen) on the time adjusted AUC of the VAS pain scores (taken on swallowing).[From the first dose of study medication until 48 hours after the first dose.];Requirement for resuce analgesia (defined by transferring patients from study medication to Maxigesic Junior or Morphine).[From the first dose of study medicine up to 48 hours after first dose.];A categorical global pain rating assessed by patients of pain as nil, mild, moderate or severe[At the end of the study i.e. up to 48 hours after the first dose];A rating of sleep disturbance on a 100 mm Visual Analogue Scale[Up to 48 hours after the first dose]