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|
|Estimated Study Completion Date:||May 2013|
|Estimated Primary Completion Date:||March 2013 (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
Vapocoolant sprays have been used to decrease the pain associated with painful medical procedures such as immunizations, needle aspirations, injections, venipuncture and intravenous cannulation. In general, vapocoolant sprays , have been found to be effective in decreasing the pain of various medical procedures. Moreover, the use of vapocoolant sprays ,unlike other local anesthetics , such as infiltrative lidocaine , is not associated with a painful injection and does affect the success rate of the procedure including intravenous cannulation and may even increase the success rate of the intravenous cannulation.
|Contact: Sharon A. O'Keefe, RN/BSN||1-800-223-2273 ext email@example.com|
|Contact: Tracy Barbour||1-800-223-2273 ext firstname.lastname@example.org|
|United States, Ohio|
|The Cleveland Clinic||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Sharon A O'Keefe, RN/BSN 216-445-4594 email@example.com|
|Contact: Tracy M Barbour 216-444-0231 firstname.lastname@example.org|
|Principal Investigator: Sharon E Mace, M.D.|
|Principal Investigator:||Sharon E. Mace, M.D.||The Cleveland Clinic|