Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000576325
Ethics application status
Approved
Date submitted
28/10/2008
Date registered
12/11/2008
Date last updated
12/11/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised trial of anti-emetics in pre-hospital care (The RAPS Trial)
Scientific title
In prehospital patients which antiemetic agent (maxolon, midazoloam or ondansetron) is superior in reducing nausea and vomiting
Universal Trial Number (UTN)
Trial acronym
Randomised trial of Antiemetics in the Prehospital Setting (RAPS Trial)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nausea and vomiting 3882 0
Condition category
Condition code
Other 4162 4162 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients to receive either
Ondansetron 4mg intramuscular injection
Midazolam 2.5mg intramuscular injection

These agents will be administered as a one off single intramuscular (IMI) injection. Followup will be continued until the patient has arrived at hospital - usually within 30 - 40 minutes.
Intervention code [1] 3684 0
Treatment: Drugs
Comparator / control treatment
Patients to receive:
Maxolon 10mg intramuscular injection

This agent will be administered as a one off single IMI injection. Followup will be continued until the patient has arrived at hospital - usually within 30 - 40 minutes.
Control group
Active

Outcomes
Primary outcome [1] 4981 0
Reduction in nausea and vomiting.
Active vomiting will be assessed by direct observation of the patient.
Nausea will be assessed using a verbal analogue scale (Rating scale of 1 - 10).
Timepoint [1] 4981 0
On arrival at hospital Emergency Departments
Secondary outcome [1] 8402 0
Significant adverse events will be assessed through either direct observation by the attending ambulance paramedic or observed / reported by clinical staff at the receiving hospital.
Timepoint [1] 8402 0
On arrival at hospital Emergency Departments

Eligibility
Key inclusion criteria
All patients managed by the ambulance service who are either actively vomiting or have a nausea score greater or equal to 4
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age less than 18
Received trial agents in the previous 24hours
Pregnant or possibly pregnant
Weight less than 60kg
Altered conscious level (Glascow Coma Score < 15)
Refuses intramuscular injection
No consent

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)
Patients identified by treating ambulance paramedics suitable for inclusion. Exclusion criteria assessed. Trial drug ampoules identical and labeled with trial number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised random number generator undertaken by the manufacturing pharmacist
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/11/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4079 0
Commercial sector/Industry
Name [1] 4079 0
St John Ambulance - Western Australian Ambulance Service
Country [1] 4079 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
St John Ambulance - Western Australian Ambulance Service
Address
Great Eastern Highway
Belmont 6104
Western Australia
Country
Australia
Secondary sponsor category [1] 3674 0
None
Name [1] 3674 0
Address [1] 3674 0
Country [1] 3674 0
Other collaborator category [1] 455 0
University
Name [1] 455 0
Emergency Medicine - University of Western Australia
Address [1] 455 0
M516
35 Stirling Hwy
Crawley 6009
Western Australia
Country [1] 455 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6209 0
University of Western Australia
Ethics committee address [1] 6209 0
Ethics committee country [1] 6209 0
Australia
Date submitted for ethics approval [1] 6209 0
Approval date [1] 6209 0
07/11/2008
Ethics approval number [1] 6209 0
RA/4/1/2167

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29076 0
Address 29076 0
Country 29076 0
Phone 29076 0
Fax 29076 0
Email 29076 0
Contact person for public queries
Name 12233 0
Associate Professor Ian Jacobs
Address 12233 0
Emergency Medicine (M516)
University of Western Australia
35 Stirling Hwy
Crawley 6009
Country 12233 0
Australia
Phone 12233 0
+61 8 9346 4354
Fax 12233 0
+ 61 8 9346 1665
Email 12233 0
ian.jacobs@uwa.edu.au
Contact person for scientific queries
Name 3161 0
Associate Professor Ian Jacobs
Address 3161 0
Univeristy of Western Australia
35 Stirling Hwy
Crawley 6009
Western Australia
Country 3161 0
Australia
Phone 3161 0
+61 8 9346 4354
Fax 3161 0
+61 8 9346 1665
Email 3161 0
ian.jacobs@uwa.edu.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.