Prospective, Randomized, Blinded,Comparative Efficacy and Safety Trial of Vapocoolant (Pain Ease Medium Stream) for Venipuncture
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pain
- Sponsor
- The Cleveland Clinic
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Pain Scale on Numeric Rating Scale (NRS) ( 0 to 10)
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
To determine the efficacy and safety of vapocoolant spray (Pain Ease Medium Stream) in decreasing the pain of venipuncture ("blood draw")
Detailed 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.
Investigators
Sharon Mace
Principal Investigator
The Cleveland Clinic
Eligibility Criteria
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)
- •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
Outcomes
Primary Outcomes
Pain Scale on Numeric Rating Scale (NRS) ( 0 to 10)
Time Frame: Less than 10 minutes after stream application.
NRS scale: 0-10 ; No pain (0) - (5) moderate pain - Worst pain (10)