Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001354279
Ethics application status
Not required
Date submitted
7/08/2018
Date registered
10/08/2018
Date last updated
10/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of two different methods of topical Anaesthesia for intravenous cannula insertion - CoolSense® (a product that cools and numbs the skin) versus EMLA® (a cream that numbs the skin).
Scientific title
CoolSense® versus EMLA® for Topical Anaesthesia for Intravenous Cannula Insertion
Secondary ID [1] 293556 0
nil known
Universal Trial Number (UTN)
U1111-1206-3426
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 305780 0
Condition category
Condition code
Anaesthesiology 304998 304998 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The volunteer will be cannulated with 2 x 20G intravenous catheters, one after another. Once following anaesthesia with Coolsense® device and then again with anaesthesia from EMLA cream which will have been applied 45 minutes previously.

The Coolsense device is applied to the skin (at the site of cannula insertion) for 10 seconds to cool and numb the skin. The vein is cannulated immediately after the device is removed from the skin. The coolsense device is administered by the person performing the cannulation. The data collector (investigator) will ensure the coolsense device is used in accordance with the manufacturer's instructions.

The same volunteer will also be cannulated on the other hand which has had application of EMLA cream to numb the skin. In this way, the participant acts as their own control. Details of the EMLA treatment are given below.
Intervention code [1] 312090 0
Treatment: Devices
Intervention code [2] 312101 0
Treatment: Drugs
Comparator / control treatment
Cannulation with 20G IV catheter following topical anaesthesia with EMLA®. EMLA is a cream containing 2.5% lignocaine and 2.5% prilocaine (local anaesthetic agents) which is applied to the skin over the site for cannulation. The cream is generously applied over the site of cannulation and covered with a clear plastic dressing at least 45 minutes prior to the cannulation attempt. The data collector (investigator) will ensure the EMLA is applied correctly.
Control group
Active

Outcomes
Primary outcome [1] 307030 0
Numerical pain rating scale of zero to ten as reported by the participant. The score will be written down by the data collector.
Timepoint [1] 307030 0
immediately following cannulation.
Secondary outcome [1] 350445 0
Preferred technique - Coolsense vs EMLA as reported by the participant (volunteer who is being cannulated).
Timepoint [1] 350445 0
Immediately following cannulation
Secondary outcome [2] 350446 0
Successful cannulation attempts. This will be recorded by the data collector observing the procedure.
Timepoint [2] 350446 0
following cannulation

Eligibility
Key inclusion criteria
Healthy volunteers
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Current anti-platelet therapy, allergy to chlorhexidine, allergy to isopropyl alcohol, history of needle phobia.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/08/2018
Actual
Date of last participant enrolment
Anticipated
31/12/2018
Actual
Date of last data collection
Anticipated
1/01/2019
Actual
Sample size
Target
63
Accrual to date
Final
Recruitment outside Australia
Country [1] 20736 0
New Zealand
State/province [1] 20736 0
Christchurch

Funding & Sponsors
Funding source category [1] 298169 0
Hospital
Name [1] 298169 0
Christchurch Hospital
Country [1] 298169 0
New Zealand
Primary sponsor type
Individual
Name
Christchurch Hospital
Address
Department of Anaesthesia
Christchurch Hospital
Private Bag 4710
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 297265 0
Individual
Name [1] 297265 0
Christchurch Hospital
Address [1] 297265 0
Department of Anaesthesia
Christchurch Hospital
Private Bag 4710
Christchurch 8140
Country [1] 297265 0
New Zealand

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 299186 0
Ethics committee address [1] 299186 0
Ethics committee country [1] 299186 0
Date submitted for ethics approval [1] 299186 0
Approval date [1] 299186 0
Ethics approval number [1] 299186 0

Summary
Brief summary
Almost all patients presenting for anaesthesia will require an intravenous cannula prior to surgery. However, many patients find this an unpleasant experience and this leads to a great deal of anxiety and in some cases needlephobia.

With the CDHB, the Coolsense® device has recently been introduced to cool and anaesthetise the skin prior to cannulation. However, there are no studies published in peer review journals comparing Coolsense® to topical anaesthetic cream, eg EMLA®.

We hypothesis that Coolsense® will provide an equivalent level of satisfaction to EMLA®.

We will ask healthy volunteers (adults over 18 years) to agree for two 20G intravenous cannulas to be inserted into each hand. Prior to insertion, one hand will be anaesthetised with the application of EMLA®, a topical local anaesthetic cream which will be applied a minimum of 45 minutes prior to cannulation and the other hand using Coolsense® according to the manufacturer’s instructions. Groups will be randomised to determine which hand is anaesthetised with Coolsense®, which hand anaesthetised with EMLA® and which hand will be first to cannulated.

The volunteers will be asked to record pain on a numerical pain rating scale of zero to ten and rate their satisfaction (scale zero to to 10) for each method of topical anaesthesia. They will then be asked to state which technique was preferred (options: EMLA, Coolsense, both similar).

Trial website
Trial related presentations / publications
Public notes
This trial was deemed to be not in the scope of the Health & Disability Ethics Committee (NZ) because it involves a low risk medical device.

The trial was approved by the University of Otago Research Office of the Canterbury District Health Board and Te Komiti Whakarite Maori consultation process.

Contacts
Principal investigator
Name 79582 0
Dr Ben van der Griend
Address 79582 0
Department of Anaesthesia
Christchurch Hospital
Private Bag 4710
Christchurch 8140
Country 79582 0
New Zealand
Phone 79582 0
+64 3 3640640
Fax 79582 0
Email 79582 0
ben.vandergriend@cdhb.health.nz
Contact person for public queries
Name 79583 0
Dr Ben van der Griend
Address 79583 0
Department of Anaesthesia
Christchurch Hospital
Private Bag 4710
Christchurch 8140
Country 79583 0
New Zealand
Phone 79583 0
+64 3 3640640
Fax 79583 0
Email 79583 0
ben.vandergriend@cdhb.health.nz
Contact person for scientific queries
Name 79584 0
Dr Ben van der Griend
Address 79584 0
Department of Anaesthesia
Christchurch Hospital
Private Bag 4710
Christchurch 8140
Country 79584 0
New Zealand
Phone 79584 0
+64 3 3640640
Fax 79584 0
Email 79584 0
ben.vandergriend@cdhb.health.nz

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.