Skin Refrigerant to Reduce the Pain Associated With IV Insertion

Brooke Army Medical Center

Status: Completed

Conditions: Pain

Treatments: Drug: Ethyl Chloride Topical Aerosol Anesthetic; Drug: Nature's Tears Sterile Water

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02499965

404187-2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups, including a placebo group

Topical Ethyl Chloride (Product B)

Active Comparator group

Description:

Ethyl Chloride Topical Aerosol Anesthetic applied to arm

Treatment:

Drug: Ethyl Chloride Topical Aerosol Anesthetic

Topical Sterile Water (Product A)

Placebo Comparator group

Description:

Nature's Tears Sterile water in an aerosol can

Treatment:

Drug: Nature's Tears Sterile Water