Vapocoolant (Pain Ease Medium Stream) for Intravenous Lines in Emergency Department Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by The Cleveland Clinic
Sponsor:
Collaborator:
Gebauer Company
Information provided by (Responsible Party):
Sharon Mace, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01670487
First received: August 13, 2012
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Pain
Device: Vapocoolant
Device: Sterile water
Phase 4

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 300
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vapocoolant (Pain Ease Medium Stream)
Application of the stream steadily 4 to 10 seconds onto the cannulation site.
Device: Vapocoolant
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients needing intravenous cannulation
  • Adults age 18 years equal or greater than.
  • Stable patient
  • Mentally competent patient able to understand the consent form

Exclusion Criteria:

  • Patients with any allergies to the spray components ( e.g.1,1,3,3, pentafluoropropane or 1,1,1,2 tetrafluoroethane )
  • Critically ill or unstable patient (e.g. sepsis or shock)
  • Infants and children of age , <18 years.
  • Pregnant
  • Intravenous cannulation site located in area of compromised blood supply. (ex: patients with Peripheral Vascular Disease , Raynaud's disease, gangrene, Buerger's disease)
  • Intravenous cannulation site located in area of insensitive skin; such as , 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670487

Contacts
Contact: Sharon A. O'Keefe, RN/BSN 1-800-223-2273 ext 54594 okeefes@ccf.org
Contact: Tracy Barbour 1-800-223-2273 ext 40231 barbout@ccf.org

Locations
United States, Ohio
The Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Sharon A O'Keefe, RN/BSN    216-445-4594    okeefes@ccf.org   
Contact: Tracy M Barbour    216-444-0231    barbout@ccf.org   
Principal Investigator: Sharon E Mace, M.D.         
Sponsors and Collaborators
The Cleveland Clinic
Gebauer Company
Investigators
Principal Investigator: Sharon E. Mace, M.D. The Cleveland Clinic
  More Information

Publications:
Responsible Party: Sharon Mace, Staff Physician & Research Director, Emergency Services Institute, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01670487     History of Changes
Other Study ID Numbers: GEB-02
Study First Received: August 13, 2012
Last Updated: December 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Vapocoolant

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014