Vapocoolant (Pain Ease) Use for Venipuncture

Study Overview
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Brief Summary
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To determine the efficacy and safety of vapocoolant spray (Pain Ease Medium Stream) in decreasing the pain of venipuncture (blood draw)

Detailed Description
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This is a prospective, randomized, blinded, comparator study. This study design is considered standard for establishing safety and efficacy data. Active treatment vapocoolant spray (Pain Ease Medium Stream) spray) will be used. There will be a placebo (sterile water) in this study. The population selected for this study, adults (excluding the very old, > 80 years old) represents a patient population that may benefit from vapocoolant spray. This is a patient population that according to the treating health care provider already requires venipuncture for blood draw but not intravenous cannulation. Because venipuncture is a painful procedure, vapocoolant may confer benefit for the relief of pain.

Official Title
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Prospective, Randomized, Blinded,Comparative Efficacy and Safety Trial of Vapocoolant (Pain Ease Medium Stream) for Venipuncture

Conditions
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Pain

Intervention / Treatment
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* Device: Vapocoolant (Pain Ease)
* Device: Nature's Tears Sterile Water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient needing venipuncture (blood draw') but not intravenous cannulation Adult 18 years and older up to and and including 80 years old Stable patient Mentally competent patient able to understand the consent form Exclusion Criteria: Patients with any allergies to the spray components (e.g. 1,1,1,3,3 pentafluoropropane or 1,1,1,2, tetrafluoroethane ) Critically ill or unstable (e.g. sepsis or shock) Extremes of age: geriatric (> 80 years) or pediatric ( < 18 years old) Pregnant Venipuncture site located in area of compromised blood supply. Examples include : patients with peripheral vascular disease, gangrene, Raynaud's disease, Buerger's disease. Venipuncture site located in area of insensitive skin; patients with a peripheral neuropathy including diabetic neuropathy. Patient intolerant of cold or with hypersensitivity to the cold. Patient unable or unwilling to give consent. Prior experience with vapocoolant spray Currently in another research trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vapocoolant (Pain Ease Medium Stream )<br>Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site. | Device: Vapocoolant (Pain Ease)<br>* Topical stream 4-10 seconds duration to skin.<br>* Other names: Pain Ease Stream;|
| Placebo Comparator: Nature's Tears Sterile Water<br>Application of sterile water stream (nature's tears) for 4-10 seconds onto the venipuncture site. | Device: Nature's Tears Sterile Water<br>* Topical stream 4-10 seconds duration to skin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scale on Numeric Rating Scale (NRS) ( 0 to 10) | NRS scale: 0-10 ; No pain (0) - (5) moderate pain - Worst pain (10) | Less than 10 minutes after stream application. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vapocoolant