Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000470493
Ethics application status
Approved
Date submitted
10/09/2007
Date registered
19/09/2007
Date last updated
21/01/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Topical vapocoolant spray in reducing the pain of intravenous cannulation in the emergency department: a randomised, single-blinded, placebo-controlled trial
Scientific title
A randomised controlled clinical trial to compare the efficacy of pressurised vapocoolant and water sprays in decreasing the pain of intravenous cannulation in emergency department patients.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain of intravenous cannulation 2349 0
Condition category
Condition code
Anaesthesiology 2455 2455 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two second spray of pressurised vapocoolant "COLD Spray" (butane, propane, pentane blend), from 12 cm, to the IV cannulation site. The alkane blend may vary with the batch and specific proportions of the three alkanes are not available
Intervention code [1] 2071 0
Prevention
Comparator / control treatment
Two second spray of pressurised Evian water spray, from 12 cm, to the IV cannulation site
Control group
Placebo

Outcomes
Primary outcome [1] 3355 0
Pain score of intravenous cannulation (0-100) on a visual analogue scale
Timepoint [1] 3355 0
One minute after cannulation
Secondary outcome [1] 5574 0
Thrombophlebitis, blistering, frostbite, redness, and swelling at the cannulation site
Timepoint [1] 5574 0
Five days after cannulation

Eligibility
Key inclusion criteria
Emergency department patients, aged 18 years or more, requiring intravenous cannulation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Refusal to provide consent; Inability to provide informed consent (Non-English speaking, altered mental state, significant illness); Moderate to severe discomfort or pain; Diseases of the skin associated with cold intolerance (eg: Raynaud’s phenomenon); Known allergy to spray contents; Peripheral neuropathy; Parenteral analgesia in the previous 4 hours

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A note containing each individual patient's allocation will be inside a sealed envelope inside each study pack
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Only the researcher administering the intervention/control spray will know the allocation. He/she will only apply the spray but will not allocate the treatment, insert the cannula, measure the pain score or analyse the data.
Phase
Phase 3
Type of endpoint/s
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
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 426 0
3084

Funding & Sponsors
Funding source category [1] 2608 0
Hospital
Name [1] 2608 0
Austin Health
Country [1] 2608 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Studley Road
Heidelberg
Victoria
Country
Australia
Secondary sponsor category [1] 2359 0
None
Name [1] 2359 0
Address [1] 2359 0
Country [1] 2359 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4528 0
Austin Health
Ethics committee address [1] 4528 0
Ethics committee country [1] 4528 0
Australia
Date submitted for ethics approval [1] 4528 0
17/09/2007
Approval date [1] 4528 0
12/11/2007
Ethics approval number [1] 4528 0

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

Contacts
Principal investigator
Name 28043 0
Address 28043 0
Country 28043 0
Phone 28043 0
Fax 28043 0
Email 28043 0
Contact person for public queries
Name 11200 0
A/Prof David Taylor
Address 11200 0
Emergency Department
Austin Health
Studley Rd
Heidelberg
Victoria
Country 11200 0
Australia
Phone 11200 0
03 9496 4883
Fax 11200 0
03 9496 3380
Email 11200 0
[email protected]
Contact person for scientific queries
Name 2128 0
A/Prof David Taylor
Address 2128 0
Emergency Department
Austin Health
Studley Rd
Heidelberg
Victoria
Country 2128 0
Australia
Phone 2128 0
03 9496 4883
Fax 2128 0
03 9496 3380
Email 2128 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
No additional documents have been identified.