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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000456550

Acronym

Maxigesic Oral Suspension Tonsillectomy Study

Enrollment

253

Registered

2015-05-11

Start date

2015-09-21

Completion date

2017-03-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

2 Years to 12 Years

Healthy volunteers

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

Outcome results