ACTRN12615000456550
Completed
Phase 2
A randomized, single-blind, parallel group, comparison of the pharmacokinetic profiles, dose response, analgesic effectiveness and safety of high and low dose of a paracetamol and ibuprofen fixed dose combination in children undergoing tonsillectomy with or without adenoidectomy
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AFT pharmaceuticals Ltd
- Enrollment
- 253
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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