Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000915257
Ethics application status
Approved
Date submitted
21/10/2009
Date registered
23/10/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Do the post operative nausea and vomiting (PONV) drugs Granisetron and Ondansetron negate the analgesic effects of Paracetamol?
Scientific title
Do the post operative nausea and vomiting (PONV) drugs Granisetron and Ondansetron negate the analgesic effects of Paracetamol in healthy male volunteers?
Secondary ID [1] 252505 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Analgesia 252040 0
Post operative nausea and vomiting 252041 0
Condition category
Condition code
Anaesthesiology 252230 252230 0 0
Pain management
Anaesthesiology 252231 252231 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Volunteers will be cannulated and a baseline pain threshold measured using a "PainMatcher". Volunteers will receive either Granisetron 1mg intravenously (iv), ondansetron 4mg intravenously (iv) or 5mls normal saline intravenously (iv) (placebo). 30 minutes later (time T 0) pain threshold will be measured followed by administration of paracetamol 1g intravenously (iv) and decannulation. Pain thresholds will be measured at T30, T60, T120, T180 and T240 using the "PainMatcher". The trial is fully randomised and double blinded. Each volunteer will attend 3 clinical sessions spaced one week apart so that they receive all three medications in a crossover fashion.
Intervention code [1] 241438 0
Treatment: Drugs
Comparator / control treatment
Normal saline
Control group
Placebo

Outcomes
Primary outcome [1] 253102 0
Pain threshold as a indication of the analgesic effect of paracetamol - measured using the "PainMatcher"
Timepoint [1] 253102 0
Baseline pain threshold
Pain thresholds at 0 mins (T0), 30 mins (T30), 60 mins (T60), 120 mins (T120), 180 mins (T180), 240 mins (T240)
Secondary outcome [1] 257972 0
Nil
Timepoint [1] 257972 0
Nil

Eligibility
Key inclusion criteria
Healthy male volunteers aged 18 to 55 years
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Female, minors, known hypersensitivity to one of the drugs, excessive caffeine consumption (> 4 cups coffee per day), excessive cigarette smoking, illicit drugs, concomitant use of prescription medication

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
20/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2157 0
4814 - Townsville

Funding & Sponsors
Funding source category [1] 243911 0
Hospital
Name [1] 243911 0
The Townsville Hospital Foundation
Country [1] 243911 0
Australia
Primary sponsor type
Individual
Name
Dr Paul Sherwin
Address
Chief Researcher
The Townsville Hospital
100 Angus Smith Drive
Douglas
Qld
4814
Country
Australia
Secondary sponsor category [1] 251256 0
Individual
Name [1] 251256 0
Dr Sancha Robinson
Address [1] 251256 0
Associate Researcher
The Townsville Hospital
100 Angus Smith Drive
Douglas
Qld
4814
Country [1] 251256 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244025 0
Townsville Health Service Human Research Ethics Committee
Ethics committee address [1] 244025 0
The Townsville Hospital
100 Angus Smith Drive
Douglas
Qld
4814
Ethics committee country [1] 244025 0
Australia
Date submitted for ethics approval [1] 244025 0
Approval date [1] 244025 0
10/09/2009
Ethics approval number [1] 244025 0
HREC/09/QTHS/67

Summary
Brief summary
12/11/2009. A pilot study checking the sensitivity of the Painmatcher is currently underway. This involves 20 healthy male volunteers who are randomised to receive either 100mls Normal Saline intravenously or 1g Paracetamol intravenously in a blinded crossover fashion. Pain thresholds are checked using the PainMatcher at T0, T30, T60, T120, T180, T240. Each volunteer has been trained four times prior to the first clinical session in the use of the PainMatcher.

18/07/2010. The pilot study has now been completed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30405 0
Address 30405 0
Country 30405 0
Phone 30405 0
Fax 30405 0
Email 30405 0
Contact person for public queries
Name 13652 0
Dr Sancha Robinson
Address 13652 0
The Townsville Hospital
100 Angus Smith Drive
Douglas
Qld
4814
Country 13652 0
Australia
Phone 13652 0
+61 428 771849
Fax 13652 0
Email 13652 0
sanchasd@yahoo.com
Contact person for scientific queries
Name 4580 0
Dr Paul Sherwin
Address 4580 0
The Townsville Hospital
100 Angus Smith Drive
Douglas
Qld
4814
Country 4580 0
Australia
Phone 4580 0
+61 437 701838
Fax 4580 0
Email 4580 0
paul_sherwin@health.qld.gov.au

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
No additional documents have been identified.