Maxigesic Oral Suspension for Children undergoing Tonsillectomy
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 Ltd
200 participants
Sep 21, 2015
Interventional
Conditions
Summary
The primary purpose of this study is to define the PK profile of the Maxigesic oral suspension plus the clinical efficacy and safety of the high dose and low dose groups. The other purpose of the study is to define the concentration-response relationship for the high dose and low dose of Maxigesic oral suspension
Eligibility
Inclusion Criteria3
- 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 Criteria3
- 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
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Interventions
Maxigesic oral suspension: paracetamol 160mg + ibuprofen 48mg / 5 mL a) Corresponding doses: low dose: paracetamol 12mg/kg + ibuprofen 3.6 mg/kg; b) The frequency and duration of administration: 4-6 hourly for 2 days post surgery c) the mode of administration, oral suspension d) Strategies used to monitor the compliance: IPs will be returned and documented in the accountability Log
Locations(2)
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ACTRN12615000456550