ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

nil known

Universal Trial Number (UTN)

U1111-1206-3426

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pain

Condition category

Condition code

Anaesthesiology

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]

Treatment: Devices

Intervention code [2]

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]

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]

immediately following cannulation.

Secondary outcome [1]

Preferred technique - Coolsense vs EMLA as reported by the participant (volunteer who is being cannulated).

Timepoint [1]

Immediately following cannulation

Secondary outcome [2]

Successful cannulation attempts. This will be recorded by the data collector observing the procedure.

Timepoint [2]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Christchurch

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Christchurch Hospital

Address [1]

Department of Anaesthesia
Christchurch Hospital
Private Bag 4710
Christchurch 8140

Country [1]

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]

Individual

Name [1]

Christchurch Hospital

Address [1]

Department of Anaesthesia
Christchurch Hospital
Private Bag 4710
Christchurch 8140

Country [1]

New Zealand

Ethics approval

Ethics application status

Not required

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Dr Ben van der Griend

Address

Department of Anaesthesia
Christchurch Hospital
Private Bag 4710
Christchurch 8140

Country

New Zealand

Phone

+64 3 3640640

Fax

ben.vandergriend@cdhb.health.nz

Contact person for public queries

Name

Ben van der Griend

Address

Department of Anaesthesia
Christchurch Hospital
Private Bag 4710
Christchurch 8140

Country

New Zealand

Phone

+64 3 3640640

Fax

ben.vandergriend@cdhb.health.nz

Contact person for scientific queries

Name

Ben van der Griend

Address

Department of Anaesthesia
Christchurch Hospital
Private Bag 4710
Christchurch 8140

Country

New Zealand

Phone

+64 3 3640640

Fax

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically