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Trial registered on ANZCTR


Registration number
ACTRN12607000005459
Ethics application status
Approved
Date submitted
22/12/2006
Date registered
4/01/2007
Date last updated
20/12/2018
Date data sharing statement initially provided
20/12/2018
Date results information initially provided
20/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Maxi-Analgesic Junior Study
Scientific title
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.
Secondary ID [1] 252264 0
AFT-MX-2
Universal Trial Number (UTN)
Trial acronym
AFT MX-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Children requiring analgesia post tonsillectomy 1508 0
Condition category
Condition code
Surgery 1606 1606 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 1522 0
Treatment: Drugs
Comparator / control treatment
Control treatment:
This will be either oral suspension of paracetamol 120mg per 5 ml or ibuprofen 60mg per 5 ml. The first dose will be administrated one hour before the operation and then very 6 hour up to 48 hours after the first dose.
Control group
Active

Outcomes
Primary outcome [1] 2215 0
To compare the analgesic effects of the 3 treatment groups (paracetamol+ibuprofen, paracetamol or ibuprofen) on the time adjusted AUC (Area under the curve) of the VAS (Visual Analogue Scale) pain scores
Timepoint [1] 2215 0
Taken at rest from the first dose of study medication until 48 hours after the first dose.
Secondary outcome [1] 3860 0
To compare the analgesic effects of the 3 treatment groups (paracetamol+ibuprofen, paracetamol or ibuprofen) on the time adjusted AUC of the VAS pain scores (taken on swallowing).
Timepoint [1] 3860 0
From the first dose of study medication until 48 hours after the first dose.
Secondary outcome [2] 3861 0
Requirement for resuce analgesia (defined by transferring patients from study medication to Maxigesic Junior or Morphine).
Timepoint [2] 3861 0
From the first dose of study medicine up to 48 hours after first dose.
Secondary outcome [3] 6493 0
A categorical global pain rating assessed by patients of pain as "nil", "mild", "moderate" or "severe"
Timepoint [3] 6493 0
At the end of the study i.e. up to 48 hours after the first dose
Secondary outcome [4] 6494 0
A rating of sleep disturbance on a 100 mm Visual Analogue Scale
Timepoint [4] 6494 0
Up to 48 hours after the first dose

Eligibility
Key inclusion criteria
Children requiring analgesia post tonsillectomy.
Minimum age
6 Years
Maximum age
14 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomisation generated by computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects and Investigators are blind to the treatment
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 457 0
New Zealand
State/province [1] 457 0
Auckland
Country [2] 458 0
India
State/province [2] 458 0
Ahmedabad

Funding & Sponsors
Funding source category [1] 1750 0
Commercial sector/Industry
Name [1] 1750 0
AFT (Atkinson Family Trust) Pharmaceuticals Ltd
Address [1] 1750 0
Level 2, 9 Anzac Street, Takapuna, Auckland, New Zealand
Country [1] 1750 0
New Zealand
Funding source category [2] 3069 0
Commercial sector/Industry
Name [2] 3069 0
AFT Pharmaceuticals Ltd
Address [2] 3069 0
Level 2, 9 Anzac Street, Takapuna, Auckland
Country [2] 3069 0
New Zealand
Primary sponsor type
Individual
Name
Hartley Atkinson, Managing Director, AFT Pharmaceuticals, Ltd
Address
Level 2, 9 Anzac Street, Takapuna, Auckland
Country
New Zealand
Secondary sponsor category [1] 1551 0
Individual
Name [1] 1551 0
Alan Merry, Professor, Department of Anathesiology, University of Auckland
Address [1] 1551 0
Ground floor, Mercy Hospital, 98-100 Mountain Road, Epsom, Auckland
Country [1] 1551 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5017 0
Northern X Regional Ethics Committee
Ethics committee address [1] 5017 0
3 Floor, Unisys Building, 650 Great South Road, Penrose, Auckland
Ethics committee country [1] 5017 0
New Zealand
Date submitted for ethics approval [1] 5017 0
29/08/2007
Approval date [1] 5017 0
11/09/2007
Ethics approval number [1] 5017 0
NTX/07/03/025

Summary
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.
Trial website
Trial related presentations / publications
Randomized comparison between the combination of acetaminophen and ibuprofen and each constituent alone for analgesia following tonsillectomy in children.
Merry AF1, Edwards KE, Ahmad Z, Barber C, Mahadevan M, Frampton C.
Can J Anaesth. 2013 Dec;60(12):1180-9.
Public notes

Contacts
Principal investigator
Name 27456 0
Prof Alan Merry
Address 27456 0
Department of Anaethesiology University of Auckland Private Bag 92019 Auckland
Country 27456 0
New Zealand
Phone 27456 0
+64 9 6236588 ext 28443
Fax 27456 0
Email 27456 0
a.merry@auckland.ac.nz
Contact person for public queries
Name 10711 0
Dr Hartley Atkinson
Address 10711 0
Po Box 33-203
Takapuna
Auckland
Country 10711 0
New Zealand
Phone 10711 0
+64 9 4880232
Fax 10711 0
+64 9 4880234
Email 10711 0
hartley@aftpharm.com
Contact person for scientific queries
Name 1639 0
Prof Alan Merry
Address 1639 0
Department of Anaethesiology
University of Auckland
Private Bag 92019
Auckland
Country 1639 0
New Zealand
Phone 1639 0
+64 9 6236588 ext 28443
Fax 1639 0
+64 9 6236587
Email 1639 0
a.merry@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
This fixed dose combination of ibuprofen and acetaminophen (acetaminophen 120 mg + ibuprofen 60 mg per 5 mL oral suspension) was not superior to its individual components in the regimen studied in this pediatric population undergoing tonsillectomy