Skin Refrigerant to Reduce the Pain Associated With IV Insertion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-05-31

Brief Summary

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The purpose of this study is to determine whether or not the pain of IV catheter insertion in the Emergency Department can be reduced significantly with the use of a rapid acting topical anesthetic spray and to determine whether or not healthcare providers who undergo such treatment are likely to endorse its use in their future practice.

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Detailed Description

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We recruited 38 emergency department healthcare providers (doctors, physician assistants, nurses and medics) to receive a total of two separate IV canulations - one in one arm and the other in the other. One IV canulation would be pretreated with Ethyl Chloride topical anesthetic (the study product) and the other would be pre-treated with a placebo (sterile water in an aerosol can). Both the participants and the nurses, PAs and medics who placed the IVs were blinded as to which was the Ethyl Chloride and which was the placebo. After the IVs were placed the participants were asked to rate the pain of IV canulation on a scale of 1 to 10 for each of the pre-treatments, to state which one they believed to be superior in reducing the pain of receiving the IV, to state whether or not they would like the intervention that they rated as superior to be used on themselves and finally how likely they were on a 5 point scale to incorporate the intervention they rated as superior into their future practice.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Topical Ethyl Chloride (Product B)

Ethyl Chloride Topical Aerosol Anesthetic applied to arm

Group Type ACTIVE_COMPARATOR

Ethyl Chloride Topical Aerosol Anesthetic

Intervention Type DRUG

Sprayed on the skin for 5-8 seconds immediately before IV cannulation

Topical Sterile Water (Product A)

Nature's Tears Sterile water in an aerosol can

Group Type PLACEBO_COMPARATOR

Nature's Tears Sterile Water

Intervention Type DRUG

Sprayed on the skin for 5-8 seconds immediately before IV cannulation

Interventions

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Ethyl Chloride Topical Aerosol Anesthetic

Sprayed on the skin for 5-8 seconds immediately before IV cannulation

Intervention Type DRUG

Nature's Tears Sterile Water

Sprayed on the skin for 5-8 seconds immediately before IV cannulation

Intervention Type DRUG

Other Intervention Names

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Study Device or Product B Placebo or Product A

Eligibility Criteria

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Inclusion Criteria

1. At least 18 years of age
2. A healthcare worker who routinely orders or places IV catheters.
3. Consents to participate in the study.

Exclusion Criteria

1. History of hypersensitivity to Ethyl Chloride.
2. Break, or swollen in the skin at the proposed IV site.
3. Pregnancy or lactating female.
4. Recent tattoo in either of the two proposed anatomical areas for IV cannulation.
5. Skin infection in either of the two proposed anatomical areas for IV cannulation.
6. Missing a contralateral limb to place the second IV.
7. Recent trauma to one of the upper extremities or any neuropathic or radicular condition that could affect the participant's perception of pain in the antecubital fossa of each arm.

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Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes