Skin Refrigerant to Reduce the Pain Associated With IV Insertion

Study Overview
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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.

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.

Official Title
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The Use of a Topical Anesthetic Skin Refrigerant to Reduce the Pain Associated With Intravenous Catheter Insertion, A Double Blinded, Patient/Placebo Controlled, Study

Conditions
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Pain

Intervention / Treatment
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* Drug: Ethyl Chloride Topical Aerosol Anesthetic
* Drug: Nature's Tears Sterile Water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age A healthcare worker who routinely orders or places IV catheters. Consents to participate in the study. Exclusion Criteria: History of hypersensitivity to Ethyl Chloride. Break, or swollen in the skin at the proposed IV site. Pregnancy or lactating female. Recent tattoo in either of the two proposed anatomical areas for IV cannulation. Skin infection in either of the two proposed anatomical areas for IV cannulation. Missing a contralateral limb to place the second IV. 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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topical Ethyl Chloride (Product B)<br>Ethyl Chloride Topical Aerosol Anesthetic applied to arm | Drug: Ethyl Chloride Topical Aerosol Anesthetic<br>* Sprayed on the skin for 5-8 seconds immediately before IV cannulation<br>* Other names: Study Device or Product B;|
| Placebo Comparator: Topical Sterile Water (Product A)<br>Nature's Tears Sterile water in an aerosol can | Drug: Nature's Tears Sterile Water<br>* Sprayed on the skin for 5-8 seconds immediately before IV cannulation<br>* Other names: Placebo or Product A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Ordinal pain scale (1-10) | 1 minute | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Topical Anesthetic, Ethyl Chloride, Pain Reduction, IV cannulation