Vapocoolant (Pain Ease Medium Stream) for Intravenous Lines in Emergency Department Patients
To determine the efficacy and safety of vapocoolant stream (Pain Ease Medium Stream ) in decreasing the pain of intravenous cannulation.
To compare vapocoolant stream (Pain Ease medium Stream) with control (e.g. sterile water) stream.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Prospective,Randomized,Blinded, Comparative,Efficacy and Safety Trial of Vapocoolant (Pain Ease Medium Stream) for Intravenous Cannulation in Emergency Department Patients.|
- Pain score on the visual analog scale [ Time Frame: <1 minute after stream device application, , 1 minute after intravenous catheter placement. ] [ Designated as safety issue: No ]Numeric rating scale (VAS) 0-10 : 0 (no pain) - 5 (moderate pain) - 10 (worst pain). Scores to be utilized after stream device applied and after intravenous catheter placement.
- Patient satisfaction with the procedure [ Time Frame: Within one hour of intravenous cannulation. ] [ Designated as safety issue: No ]Patient self reported satisfaction with the procedure using an eight item questionnaire developed specifically for the study.
- Health Care Provider satisfaction with the procedure [ Time Frame: Within one hour of intravenous cannulation. ] [ Designated as safety issue: No ]Health Care provider self reported satisfaction with the procedure using a six item questionnaire developed specifically for the study
- Ease of insertion of intravenous catheter placement [ Time Frame: Duration of time to establish an IV catheter in the Emergency Department ] [ Designated as safety issue: No ]Questionnaire: Success in one attempt; number of attempts ; location of intravenous catheter placement;Health care provider inserting IV catheter ( Registered Nurse, paramedic, Emergency Medical Technician, Nurse Practitioner /Physician Assistant , Medical Doctor ); years of experience of performing IV's
- Number of participants with adverse events. [ Time Frame: Within 1 hour after application of the device ] [ Designated as safety issue: Yes ]Utilized as a measure of safety and tolerability.Skin assessment at site of post stream device application /Clinical assessment : description of skin at site: redness, blanching, change in skin color pigmentation. Photograph of site to confirm clinical description.
|Study Start Date:||October 2012|
|Study Completion Date:||December 2014|
|Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Vapocoolant (Pain Ease Medium Stream)
Application of the stream steadily 4 to 10 seconds onto the cannulation site.
Topical stream of 4 to 10 seconds duration to skin
Other Name: Pain Ease stream
Placebo Comparator: Nature's Tears
Apply sterile water (see manufacturer above) steadily 4-10 seconds onto the cannulation site.
Device: Sterile water
Topical intervention of sterile water stream 4 to 10 seconds to skin.
Other Name: Nature's Tears by Bio-Logic Aqua Technologies
Please refer to this study by its ClinicalTrials.gov identifier: NCT01670487
|United States, Ohio|
|The Cleveland Clinic|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Sharon E. Mace, M.D.||The Cleveland Clinic|