Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000441415
Ethics application status
Approved
Date submitted
20/04/2007
Date registered
31/08/2007
Date last updated
29/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Morphine versus Ketamine for traumatic pain in the prehospital setting
Scientific title
Reduction in pain Verbal Numeric Rating Scale (VNRS) using morphine compared to Ketamine for patients presenting with traumatic pain in the prehospital setting
Secondary ID [1] 260094 0
Morphine versus ketamine
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate to Severe traumatic Pain 2152 0
Condition category
Condition code
Musculoskeletal 2333 2333 0 0
Other muscular and skeletal disorders
Injuries and Accidents 2393 2393 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ketamine Hydrochloride (Intervention) 10-20 mgs bolus Intraveneously every three minutes. Patients will continue to receive boluses of the drug until either; 1. Patient is pain free 2. Side effects develop or 3. Arrival at a receiving Emergency Department
Intervention code [1] 1954 0
Treatment: Drugs
Comparator / control treatment
Morphine Sulphate (Control) 1 - 5 mgs bolus Intraveneously every five minutes. Patients will continue to receive boluses of the drug until either; 1. Patient is pain free 2. Side effects develop or 3. Arrival at a receiving Emergency Department
Control group
Active

Outcomes
Primary outcome [1] 3228 0
Change in pain Verbal Numeric Rating Scale (VNRS)
Timepoint [1] 3228 0
On arrival at a receiving hospital Emergency Department
Secondary outcome [1] 5215 0
Chronic pain / functionality score
Timepoint [1] 5215 0
At 6 months
Secondary outcome [2] 5217 0
Incidence of adverse events, such as excessive sedation, blood pressure changes, arrhythmias, nause and vomiting
Timepoint [2] 5217 0
Until arrival at a receiving Emergency Department
Secondary outcome [3] 5218 0
Total dose of opioid required for pain relief
Timepoint [3] 5218 0
On arrival at a receiving hospital Emergency Department

Eligibility
Key inclusion criteria
Attended by participating ambulance crew
Patient conscious (GCS=15), speaking and able to rate their pain using the Verbal Numerical Rating Scale (VNRS) Moderate to Severe pain due to trauma defined as VNRS of 5 or greater.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known allergy to ketamine hydrochloride or morphine sulphate
Pregnant or lactating women
Ischameic chest pain, acute pulmonary oedema and/or severe hypertension (Systolic Blood Pressure>180 mmHg)
Head injury with a history of loss of consciousness or Glasgow Coma Scale<15
Inability to obtain venous access
Presumed intoxication with alcohol or illicit substances

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 will be allocated to receive intravenous morphine and ketamine or intravenous morphine alone. Randomisation will be decided by sealed opaque envelope block randomisation following inclusion into the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated to one of the two study arms dependant upon opaque envelope block randomisation. Envelopes will be randomly shuffled and then sequentially numbered.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2405 0
Government body
Name [1] 2405 0
Transport Accident Commission
Country [1] 2405 0
Australia
Funding source category [2] 2406 0
Other
Name [2] 2406 0
Rural Ambulance Victoria
Country [2] 2406 0
Australia
Funding source category [3] 2407 0
Other
Name [3] 2407 0
Metropolitan Ambulance Service
Country [3] 2407 0
Australia
Primary sponsor type
Individual
Name
Prof. Peter Cameron
Address
Monash University
Commercial Road,
Prahran, Melbourne
Country
Australia
Secondary sponsor category [1] 2181 0
Individual
Name [1] 2181 0
Mr Paul Jennings
Address [1] 2181 0
Rural Ambulance Victoria
23 Wetlands Drive
Mount Helen VIC 3350
Country [1] 2181 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4478 0
The Alfred Hospital HREC
Ethics committee address [1] 4478 0
Ethics committee country [1] 4478 0
Australia
Date submitted for ethics approval [1] 4478 0
06/06/2007
Approval date [1] 4478 0
14/07/2007
Ethics approval number [1] 4478 0
96/07

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

Contacts
Principal investigator
Name 27817 0
Address 27817 0
Country 27817 0
Phone 27817 0
Fax 27817 0
Email 27817 0
Contact person for public queries
Name 10903 0
Mr Paul Jennings
Address 10903 0
23 Wetlands Drive
Mount Helen VIC 3350
Country 10903 0
Australia
Phone 10903 0
03 5338 5308
Fax 10903 0
03 5338 5312
Email 10903 0
[email protected]
Contact person for scientific queries
Name 1831 0
Mr Paul Jennings
Address 1831 0
23 Wetlands Drive
Mount Helen VIC 3350
Country 1831 0
Australia
Phone 1831 0
03 5338 5308
Fax 1831 0
03 5338 5312
Email 1831 0
[email protected]

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 AILong-term pain prevalence and health-related quality of life outcomes for patients enrolled in a ketamine versus morphine for prehospital traumatic pain randomised controlled trial2013https://doi.org/10.1136/emermed-2013-202862
N.B. These documents automatically identified may not have been verified by the study sponsor.