Vapocoolant (Pain Ease Medium Stream) for Intravenous Lines in Emergency Department Patients
|ClinicalTrials.gov Identifier: NCT01670487|
Recruitment Status : Completed
First Posted : August 22, 2012
Results First Posted : September 21, 2016
Last Update Posted : September 21, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Pain||Device: Vapocoolant Device: Sterile water||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, 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.|
|Study Start Date :||October 2012|
|Primary Completion Date :||November 2014|
|Study Completion Date :||December 2014|
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
- Pain Score on the Numeric Rating Scale (NRS) [ Time Frame: pain of intravenous catheter placement. ]Numeric rating scale (NRS) 0-10 : 0 (no pain) - 5 (moderate pain) - 10 (worst pain). Scores to be utilized after stream device applied and after intravenous catheter placement.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01670487
|United States, Ohio|
|The Cleveland Clinic|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Sharon E. Mace, M.D.||The Cleveland Clinic|