Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000291583
Ethics application status
Approved
Date submitted
4/07/2006
Date registered
10/07/2006
Date last updated
2/09/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Maxi-Analgesic Study
Scientific title
Maxi-Analgesic Study. A prospective, parallel group, double-blind comparison of the analgesic effect of a combination of paracetamol and ibuprofen, paracetamol alone or ibuprofen alone in patients with post-operative pain.
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative Analgesia 1265 0
Condition category
Condition code
Surgery 1351 1351 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Post-operative analgesia with Oral Maxigesic (paracetamol 1g + Ibuprofen 300mg) four times a day for 48 hours post-operatively
Intervention code [1] 1187 0
Treatment: Drugs
Comparator / control treatment
Group 1: Oral paracetamol 1g four times a day up to 48 hours post-operatively
Group 2: Ibuprofen 300mg four times a day up to 48 hours post-operatively
Control group
Active

Outcomes
Primary outcome [1] 1842 0
The primary objective is to compare the analgesic efficacy measured by 100mm Visual Analgue Scale Area under the Curve measurements (VAS AUC measurements) (resting and on activity) of 3 different analgesic treatment regimens.
Timepoint [1] 1842 0
These will be taken at rest and on relevant activity.
Secondary outcome [1] 3229 0
1) the requirement for rescue analgesia over the study period
Timepoint [1] 3229 0
Assessed at the end of the study period (24-48 hrs post-op).
Secondary outcome [2] 3230 0
2) a categorical global rating by the patients of pain as “nil”, “mild”, “moderate” or “severe”.
Timepoint [2] 3230 0
Assessed at the end of the study period.
Secondary outcome [3] 3231 0
3) the total dose of anti-emetic used over the study period
Timepoint [3] 3231 0
Assessed at the end of the study period (24-48 hrs post-op).
Secondary outcome [4] 3232 0
4) a categorical global rating by the patient of nausea as “nil”, “mild”, “moderate” or “severe” for the period of the study.
Timepoint [4] 3232 0
Assessed at the end of the study period.
Secondary outcome [5] 3233 0
5 ) number of episodes of vomiting over the period of the study
Timepoint [5] 3233 0
Assessed at the end of the study period (24-48 hrs post-op).
Secondary outcome [6] 3234 0
6) a rating of sleep disturbance on a 100 mm Visual Analogue Scale (0 worst, 100 best) for the study period.
Timepoint [6] 3234 0
Assessed after each night during the study period.
Secondary outcome [7] 3235 0
7) a categorical rating of the experience of taking part in the study (as “very positive”, “positive”, “neutral”, “negative”, and “very negative” with the opportunity for free comments.
Timepoint [7] 3235 0
Assessed at the end of the study period.
Secondary outcome [8] 3236 0
8) Correlation of drug serum concentrations and pain scores for patients in oral surgery General Anaesthetic groups using computer statistical modelling
Timepoint [8] 3236 0
one plasma sample 30 minutes after first dose, then 1-2 further samples when the patient has progressed to the recovery room post-op or the hospital ward

Eligibility
Key inclusion criteria
Undergoing oral surgery (including extraction of at least one lower 8th molar tooth under local or general anaesthetic).
Minimum age
16 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Consent:• Patient declinedStudy contra-indications:• Too young (< 16 years)• Other Non-steroidal anti-inflammatory drug (NSAID) (other than aspirin = 150mg mg/day) or opioid within 24 hours prior to operation• Treatment within 12 hours with other paracetamol or paracetamol containing medicines (e.g. cold treatments) • Pregnant or possibly pregnant• Breastfeeding• Neurological disorder relating to pain perception• History of drug addiction• Currently on another experimental agent• Weight < 50kg• Belief by the clinician that participation in the study may compromise the patient NSAID and/or paracetamol contra-indications:• Hypersensitive to aspirin or other NSAID• Hypersensitive to paracetamol• Severe known haemopoetic, renal* or hepatic disease• GI ulcer, severe asthma, allergy etc• Currently on ACE inhibitor, warfarin, steroid (other than dexamethasone intra-operatively)**, cyclosporin, tacrolimus, methotrexate• Severe local infection. Immunosuppressed.

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)
Double-blinded trial medicines. Allocation is concealed by sealed opaque enevelopes. The person determining if the patient is elegible for inclusion, the surgeon and the study nurse are unaware of the treatment group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised into treatment blocks. Simple randomisation by using a randomization table created by computer software (i.e., computerised sequence generation). Stratification is used to allocate patients to either local anaesthetic of general anaesthetic groups and also to study centre
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 374 0
New Zealand
State/province [1] 374 0

Funding & Sponsors
Funding source category [1] 1481 0
Commercial sector/Industry
Name [1] 1481 0
NZTE & AFT Pharmaceuticals
Country [1] 1481 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
AFT Pharmaceuticals
Address
Level 2, 9 Anzac ST, Takapuna, Auckland, NEW ZEALAND
Country
New Zealand
Secondary sponsor category [1] 1305 0
Government body
Name [1] 1305 0
NZTE
Address [1] 1305 0
Level 11, ANZ Centre, 23-29 Albert St, Auckland, NZ
Country [1] 1305 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2860 0
Mercy Hospital
Ethics committee address [1] 2860 0
Mountain Rd, Epsom, Auckland
Ethics committee country [1] 2860 0
New Zealand
Date submitted for ethics approval [1] 2860 0
Approval date [1] 2860 0
12/11/2004
Ethics approval number [1] 2860 0
AKX/04/10/298
Ethics committee name [2] 2861 0
Greenlane Hospital
Ethics committee address [2] 2861 0
Greenlane, Auckland
Ethics committee country [2] 2861 0
New Zealand
Date submitted for ethics approval [2] 2861 0
Approval date [2] 2861 0
12/11/2004
Ethics approval number [2] 2861 0
AKX/04/10/298
Ethics committee name [3] 2862 0
Quay Park Surgical Centre
Ethics committee address [3] 2862 0
Parnell, Auckland
Ethics committee country [3] 2862 0
New Zealand
Date submitted for ethics approval [3] 2862 0
Approval date [3] 2862 0
13/12/2005
Ethics approval number [3] 2862 0
AKX/04/10/298

Summary
Brief summary
Measurement of relative differences in post-operative analgesia with 3 different treatments assessed by measurement of reduction in visual analogue scales AUC measurements. Investigators and patients are blinded until after the study is completed, the study database loaded and verified.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36226 0
Address 36226 0
Country 36226 0
Phone 36226 0
Fax 36226 0
Email 36226 0
Contact person for public queries
Name 10376 0
Dr Hartley ATkinson
Address 10376 0
Level 2, 9 Anzac St, Takapuna, Auckland
Country 10376 0
New Zealand
Phone 10376 0
+6494880232
Fax 10376 0
+6494880234
Email 10376 0
hartley@aftpharm.com
Contact person for scientific queries
Name 1304 0
Professor Alan Merry
Address 1304 0
Professor and Head of Department
Department of Anaesthesiology
University of Auckland
Private Bag 92019
Auckland
Country 1304 0
New Zealand
Phone 1304 0
+649-623 6833 ext. 28443
Fax 1304 0
(64 9) 3737970
Email 1304 0
a.merry@auckland.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AICombined acetaminophen and ibuprofen for pain relief after oral surgery in adults: a randomized controlled trial2010https://doi.org/10.1093/bja/aep338
N.B. These documents automatically identified may not have been verified by the study sponsor.