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

This study is currently recruiting participants.
Verified October 2012 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: October 20, 2012
Last verified: October 2012
History of Changes
  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:

MedlinePlus related topics: Drinking Water
U.S. FDA Resources

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: May 2013
Estimated Primary Completion Date: March 2013 (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
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: October 20, 2012
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 June 17, 2013