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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000005459

Acronym

AFT MX-2

Enrollment

152

Registered

2007-01-04

Start date

2008-10-17

Completion date

2010-06-10

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 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.

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 and then 6 hourly up to 48 hours after the first dose.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

6 Years to 14 Years

Healthy volunteers

Inclusion criteria

Children requiring analgesia post tonsillectomy.

Exclusion criteria

Too young or too old.Too small (weight below 15 kg at base line visit)Having taken any NSAID or paracetamol within 12 hours prior to the operation.

Outcome results