Vapocoolant (Pain Ease) Use for Venipuncture
To determine the efficacy and safety of vapocoolant spray (Pain Ease Medium Stream) in decreasing the pain of venipuncture ("blood draw")
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Prospective, Randomized, Blinded,Comparative Efficacy and Safety Trial of Vapocoolant (Pain Ease Medium Stream) for Venipuncture|
- Pain Scale on Numeric Rating Scale (NRS) (1 to 10) [ Time Frame: Less than 10 minutes after stream application. ] [ Designated as safety issue: No ]NRS scale: 0-10 ; No pain (0) - (5) moderate pain - Worst pain (10)
|Study Start Date:||April 2011|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Vapocoolant (Pain Ease Medium Stream )
Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.
Device: Vapocoolant (Pain Ease)
Topical stream 4-10 seconds duration to skin.
Other Name: Pain Ease Stream
Placebo Comparator: Nature's Tears
Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712776
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Sharon E. Mace, M.D.||The Cleveland Clinic|