Vapocoolant (Pain Ease) Use for Venipuncture



Status:Completed
Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 80
Updated:4/21/2016
Start Date:April 2011
End Date:February 2012

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

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

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.

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
We found this trial at
1
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
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