Vapocoolant Spray Used Prior to Intravenous (IV) Insertions

Study Overview
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Brief Summary
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The primary purpose of this study is to determine if by offering a vapocoolant (cold spray) to hospital outpatients prior to an intravenous catheter (IV) insertion will increase patient satisfaction of IV insertion as well as determine if pain of insertion is decreased.

Detailed Description
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This is a single blind interventional study with a post design using a convenience sample of patients undergoing a Nuclear Medicine Stress Test. The patient selection and intervention will be randomized in order to ensure a high validity study. The interventional treatment used will be a ethyl chloride mist spray manufactured by the Gebauer Company. The placebo spray that will be used is manufactured by BioLogic Aqua Research Technologies International Inc. The spray is called Nature's Tears Mist and is a sterile water. The patient's for this study are required to have intravenous cannulation (IV) access. This is a painful and invasive procedure in which a vapocoolant may confer benefit for the relief of pain.

Official Title
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Will Patients Perceive a Vapocoolant Spray to be Effective in Reducing Pain and Increasing Satisfaction With Insertion at an Intravenous Site?

Conditions
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Pain

Intervention / Treatment
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* Drug: Gebauer Ethyl Chloride
* Drug: Nature's Tears


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any outpatient ordered to undergo a Nuclear Medicine Stress Test and is required to have IV access for injection of Radiopharmaceuticals Exclusion Criteria: If it is the first time the patient has had an intravenous catheter inserted Any patient who is or may be pregnant Any patient who is breast-feeding Any patient who has taken a narcotic, sedative and/or anti-anxiety medication within 8 hours of intervention time. Any patient who has a known diagnosis of Raynaud's Syndrome or Carpal Tunnel Syndrome. Any patient who has an allergy or hypersensitivity to Ethyl Chloride. Any patient under the age of 18 and/or any patient over the age of 85 Any patient who is illiterate Any patient who is non-English speaking Any patient with prior experience with a vapocoolant spray.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gebauer Ethyl Chloride<br>Device: Vapocoolant (Ethyl Chloride Mist Spray) | Drug: Gebauer Ethyl Chloride<br>* Will be administered according to manufacturers recommendations which is to spray the aerosol can for 4-10 seconds from a distance of 3 to 9 inches. Do not spray longer than 10 seconds.<br>* Other names: Ethyl Chloride Mist Spray Can;|
| Placebo Comparator: Nature's Tears<br>Device: Sterile Water | Drug: Nature's Tears<br>* Sterile water mist will be administered 1-2 sprays prior to intravenous access<br>* Other names: Sterile Water;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scale Using Visual Analog Scale | 0-No Pain; 1-3 Mild Pain; 4-6 Moderate-Severe Pain; 7-9 Very Severe Pain;10 Worst Possible Pain | less than 5 minutes following spray application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction Scale Using 1-5 Likert Scale | 1-Very Satisfied; 2-Somewhat Satisfied; 3-Neither Satisfied or Dissatisfied; 4-Somewhat Satisfied; 5-Very Satisfied | less than 5 minutes following spray application | 
| Using the Same Likert Scale Rate How Satisfied the Patient Remembers the Last Time They Had IV Catheter Inserted | 1-5 Likert Scale 1 very dissatisfied, 2 somewhat dissatisfied, 3 neither satisfied or dissatisfied, 4 somewhat satisfied, 5 very satisfied | At baseline prior to spray application | 
| Using the Same Visual Analog Scale Rate Pain the Last Time the Patient Remembers Having an IV Inserted | Visual Analog Scale 0 no pain, 1-2 mild, 3-5 moderate, 6 severe, 7-8 very severe, 9-10 worst possible pain | At baseline prior to spray application | 
| Would Patient Choose to Have Intervention Again if IV Catheter Insertion is Needed | Yes or No question | less than 10 minutes following spray application | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vapocoolant applied prior to IV access