Skin Refrigerant to Reduce the Pain Associated With IV Insertion

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: Nature's Tears Sterile Water; Drug: Ethyl Chloride Topical Aerosol Anesthetic

• Registration Number: NCT02499965
• Lead Sponsor: Brooke Army Medical Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2015-04
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-07
• Study First Submitted: 2015-07-14
• Study First Submitted QC: 2015-07-15
• Last Update Submitted: 2015-07-15
• Study First Posted: 2015-07-16
• Last Update Posted: 2015-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical Sterile Water (Product A)	Nature's Tears Sterile Water	Nature's Tears Sterile water in an aerosol can
Topical Ethyl Chloride (Product B)	Ethyl Chloride Topical Aerosol Anesthetic	Ethyl Chloride Topical Aerosol Anesthetic applied to arm

Primary Outcome Measures

Name	Time	Method
Pain	1 minute	Ordinal pain scale (1-10)

Secondary Outcome Measures

Name	Time	Method
Preferred product	1 minute	Categorical selection of preferred product for use on self prior to IV placement
Desire to use on self in future	1 minute	Binary (yes, no) desire to use on self prior to IV placement in future
Desire to use on patients in future	1 minute	Binary (yes, no) desire to use on patients prior to IV placement in future
Likelihood to use on patients in future	1 minute	5 point likert scale ranging from "very unlikely" to "very likely"

Trial Locations

Locations (1)

Brooke Army Medical Center; 🇺🇸 Fort Sam Houston, Texas, United States