CompletedPhase 3ACTRN12607000005459

Maxi-Analgesic Junior Study

Maxi-Analgesic Junior Study: Double-blind, randomized, comparison of the analgesic effect of Paracetamol and Ibuprofen Combined versus Paracetamol or Ibuprofen alone in Post Tonsillectomy Patients.


Sponsor

Hartley Atkinson, Managing Director, AFT Pharmaceuticals, Ltd

Enrollment

150 participants

Start Date

Oct 17, 2008

Study Type

Interventional

Conditions

Summary

The study hypothesis is that the combination of appropriate clincal doses of ibuprofen and paracetamol has greater analgesic efficacy than the same doses of either paracetamol or ibupofen alone.


Eligibility

Sex: Both males and femalesMin Age: 6 YearssMax Age: 14 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests pain relief options for children after tonsillectomy (tonsil removal surgery). It is for children aged 6-14 who weigh at least 15 kg. Participants must not have taken any anti-inflammatory drugs (NSAIDs) or paracetamol within 12 hours before the operation.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Intervention treatment: This will be oral suspension of paracetamol 120mg+ Ibuprofen 60 mg per 5 ml and will be taken every 6 hour. The first dose will be administrated one hour before the operation

Intervention treatment: This will be oral suspension of paracetamol 120mg+ Ibuprofen 60 mg per 5 ml and will be taken every 6 hour. The first dose will be administrated one hour before the operation and then 6 hourly up to 48 hours after the first dose.


Locations(2)

Auckland, New Zealand

Ahmedabad, India

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ACTRN12607000005459