Vapocoolant (Pain Ease) Use for Venipuncture

NeuroTherapia, Inc.

Status: Completed

Conditions: Pain

Treatments: Device: Nature's Tears Sterile Water; Device: Vapocoolant (Pain Ease)

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT01712776

GEB-01

Details and patient eligibility

About

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

Full description

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Vapocoolant (Pain Ease Medium Stream )

Active Comparator group

Description:

Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.

Treatment:

Device: Vapocoolant (Pain Ease)

Nature's Tears Sterile Water

Placebo Comparator group

Description:

Application of sterile water stream (nature's tears) for 4-10 seconds onto the venipuncture site.

Treatment:

Device: Nature's Tears Sterile Water