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Clinical Trials/ACTRN12615000456550
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

AFT pharmaceuticals Ltd0 sites253 target enrollmentMay 11, 2015

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.

Registry
who.int
Start Date
May 11, 2015
End Date
May 9, 2017
Last Updated
6 years ago
Study Type
Interventional
Sex
All

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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