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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

August 13, 2012
December 13, 2013
October 2012
December 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01670487 on ClinicalTrials.gov Archive Site
  • 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.
satisfaction of patient and health care provider. [ Time Frame: Within one hour of intravenous cannulation. ] [ Designated as safety issue: No ]
Questionnaire for both the patient and the healthcare provider to be completed after the intravenous cannulation.
Not Provided
  • Number of participants with adverse events. [ Time Frame: <10 minutes after the use of the stream device ] [ Designated as safety issue: Yes ]
    Utilized as a measure of safety and tolerability.
  • Skin assessment at site of post stream device application / Intravenous catheter placement [ Time Frame: Within 10 minutes after intravenous cannulation. ] [ Designated as safety issue: Yes ]
    Clinical assessment : description of skin at site: redness, blanching, change in skin color pigmentation. Photograph of site to confirm clinical description.
 
Vapocoolant (Pain Ease Medium Stream) for Intravenous Lines in Emergency Department Patients
Prospective,Randomized,Blinded, Comparative,Efficacy and Safety Trial of Vapocoolant (Pain Ease Medium Stream) for Intravenous Cannulation 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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Pain
  • Device: Vapocoolant
    Topical stream of 4 to 10 seconds duration to skin
    Other Name: Pain Ease stream
  • 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
  • Active Comparator: Vapocoolant (Pain Ease Medium Stream)
    Application of the stream steadily 4 to 10 seconds onto the cannulation site.
    Intervention: Device: Vapocoolant
  • Placebo Comparator: Nature's Tears
    Apply sterile water (see manufacturer above) steadily 4-10 seconds onto the cannulation site.
    Intervention: Device: Sterile water

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
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
United States
 
NCT01670487
GEB-02
Yes
Sharon Mace, The Cleveland Clinic
The Cleveland Clinic
Gebauer Company
Principal Investigator: Sharon E. Mace, M.D. The Cleveland Clinic
The Cleveland Clinic
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP