Skip to content

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).

CoolSense® versus EMLA® for Topical Anaesthesia for Intravenous Cannula Insertion

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001354279
Enrollment
63
Registered
2018-08-10
Start date
2018-08-13
Completion date
2018-12-31
Last updated
2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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).

Interventions

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 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.

Sponsors

Christchurch Hospital
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Healthy volunteers

Exclusion criteria

Current anti-platelet therapy, allergy to chlorhexidine, allergy to isopropyl alcohol, history of needle phobia.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026