Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000414314
Ethics application status
Approved
Date submitted
4/08/2008
Date registered
22/08/2008
Date last updated
21/01/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Topical alkane vapocoolant spray versus subcutaneous lignocaine injection for reducing the pain of intravenous cannulation: a randomised, controlled, clinical trial
Scientific title
A randomised clinical trial to compare the efficacy of pressurised vapocoolant spray and subcutaneous lignocaine injection in decreasing the pain of intravenous cannulation in the emergency department
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain of intravenous cannulation 3501 0
Condition category
Condition code
Anaesthesiology 3656 3656 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two second spray of pressurised vapocoolant 'Cold Spray' (butane, propane and pentane blend), from 12 cm, to the cannulation site. The alkane blend may vary with the batch and specific proportions of the three alkanes are not available.
Intervention code [1] 3223 0
Prevention
Comparator / control treatment
Subcutaneous injection of 0.2ml of plain 1% lignocaine local anaesthetic
Control group
Active

Outcomes
Primary outcome [1] 4560 0
Pain score of intravenous cannulation (0-100) on a visual analogue scale
Timepoint [1] 4560 0
one minute after cannulation
Secondary outcome [1] 7711 0
Thrombophlebitis, blistering, frostbite, redness and swelling at the cannulation site
Timepoint [1] 7711 0
5 days after cannulation

Eligibility
Key inclusion criteria
Emergency department patients, aged 18 years or more, requiring intravenous cannulation
Minimum age
18 Years
Maximum age
100 Years
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, urgent need for IV cannulation)
Moderate to severe discomfort or pain
Diseases of the skin associated with cold intolerance (eg: Raynaud’s)
Known allergy to spray contents or lignocaine
Peripheral neuropathy
Parenteral analgesia in the previous 4 hours
Use of other local anaesthetics

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 number
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Due to difficulties in blinding the intervention and control, this will be an open study. The emergency department staff member cannulating the patient will administer either the vapocoolant spray or subcutaneous lignocaine, under the direction of a study investigator.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3675 0
Hospital
Name [1] 3675 0
Austin Health
Country [1] 3675 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Studley Rd
Heidelberg
Victoria
Country
Australia
Secondary sponsor category [1] 3300 0
None
Name [1] 3300 0
Address [1] 3300 0
Country [1] 3300 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5729 0
Austin Health
Ethics committee address [1] 5729 0
Ethics committee country [1] 5729 0
Australia
Date submitted for ethics approval [1] 5729 0
20/08/2008
Approval date [1] 5729 0
31/10/2008
Ethics approval number [1] 5729 0
not available at present

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

Contacts
Principal investigator
Name 28805 0
Address 28805 0
Country 28805 0
Phone 28805 0
Fax 28805 0
Email 28805 0
Contact person for public queries
Name 11962 0
A/Prof David Taylor
Address 11962 0
Studley Rd
Heidelberg
Victoria
Country 11962 0
Australia
Phone 11962 0
03 9496 4883
Fax 11962 0
03 9496 3380
Email 11962 0
David.Taylor@austin.org.au
Contact person for scientific queries
Name 2890 0
A/Prof David Taylor
Address 2890 0
Studley Rd
Heidelberg
Victoria
Country 2890 0
Australia
Phone 2890 0
03 9496 4883
Fax 2890 0
03 9496 3380
Email 2890 0
David.Taylor@austin.org.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
SourceTitleYear of PublicationDOI
Dimensions AIVapocoolant spray vs subcutaneous lidocaine injection for reducing the pain of intravenous cannulation: a randomized, controlled, clinical trial2010https://doi.org/10.1093/bja/aeq198
N.B. These documents automatically identified may not have been verified by the study sponsor.