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Vapocoolant (Pain Ease) Use for Venipuncture

This study has been completed.
Sponsor:
Collaborator:
Gebauer Company
Information provided by (Responsible Party):
Sharon Mace, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01712776
First received: October 4, 2012
Last updated: October 23, 2012
Last verified: October 2012
History of Changes
  Purpose

To determine the efficacy and safety of vapocoolant spray (Pain Ease Medium Stream) in decreasing the pain of venipuncture ("blood draw")


Condition Intervention Phase
Pain
 Device: Vapocoolant (Pain Ease)
Device: Sterile water (Nature's Tears)
 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: Treatment
Official Title: Prospective, Randomized, Blinded,Comparative Efficacy and Safety Trial of Vapocoolant (Pain Ease Medium Stream) for Venipuncture

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 scale on Visual Analog Scale (adults)and Wong Baker Faces pain scale for children: ages 3-8 years of age. [ Time Frame: Less thjan 10 minutes after stream application. ] [ Designated as safety issue: No ]

    Adult: VAS scale: 0-10 ; No pain (0) - (5) moderate pain - Worst pain (10)

    Pediatric: Wong Baker Faces scale 0-10 : 0 ( No hurt) 6 (Hurts Even More) to 10 (Hurts worst)



Secondary Outcome Measures:
  • Satisfaction of Patient /Parent or Guardian and Health Care provider [ Time Frame: Within 60 minutes after stream application of vewnipuncture ] [ Designated as safety issue: No ]
    Questionnaire for: patient , Parent/ Guardian, Health Care Provider


Other Outcome Measures:
  • Number of participants with adverse events [ Time Frame: Less than 10 minutes after use of stream device. ] [ Designated as safety issue: Yes ]
    Utilized as a measure of safety and tolerability.

  • Skin assessment at site of post stream application /venipuncture site. [ Time Frame: Less thasn 10 minutes after venipuncture. ] [ Designated as safety issue: Yes ]

    Clinical assessment: description of skin at venipuncture site.redness, blanching, change in skin color and pigmentation.

    Photograph of site to confirm clinical description.



Enrollment: 100
Study Start Date: April 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vapocoolant (Pain Ease Medium Stream )
Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.
 Device: Vapocoolant (Pain Ease)
Topical stream 4-10 seconds duration to skin.
Other Name: Pain Ease Stream
Placebo Comparator: Nature's Tears
Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.
 Device: Sterile water (Nature's Tears)
Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin.
Other Name: Nature's Tears bu Biologic Aqua Technologies

Detailed Description:

This is a prospective, randomized, blinded, comparator study. This study design is considered standard for establishing safety and efficacy data. Active treatment vapocoolant spray (Pain Ease Medium Stream) spray) will be used. There will be a placebo (sterile water) in this study. The population selected for this study, adult nongeriatric patients and pediatric patients (excluding the very young) represents a patient population that may benefit from vapocoolant spray. This is a patient population that according to the treating health care provider already requires venipuncture for "blood draw" but not intravenous cannulation. Because venipuncture is a painful procedure, vapocoolant may confer benefit for the relief of pain.

  Eligibility

Ages Eligible for Study:   3 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient needing venipuncture ("blood draw') but not intravenous cannulation
  • Non-geriatric adult age less than or equal to 21 years of age and less than or equal 75 years; or a child age (less than or equl years of age up to 21 years of age.
  • Stable patient
  • Mentally competent patient or parent/guardian (if applicable) able to understand the consent form and child able to understand the assent form (if applicable)

Exclusion Criteria:

  • Patients with any allergies to the spray components (e.g. 1,1,1,3,3 pentafluoropropane or 1,1,1,2, tetrafluoroethane )
  • Critically ill or unstable (e.g. sepsis or shock)
  • Extremes of age: geriatric (> 75 years) or very young ( e.g. infant /toddler, age < 3 years old)
  • Pregnant
  • Venipuncture site located in area of compromised blood supply. Examples include : patients with peripheral vascular disease ,gangrene, Raynaud's disease, Buerger's disease.
  • Venipuncture site located in area of insensitive skin; patients with a peripheral neuropathy including diabetic neuropathy.
  • Patient intolerant of cold or with hypersensitivity to the cold.
  • Patient or parent/guardian (if applicable ) unable or unwilling to give consent/assent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712776

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, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01712776     History of Changes
Other Study ID Numbers: GEB-01
Study First Received: October 4, 2012
Last Updated: October 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Vapocoolant

ClinicalTrials.gov processed this record on May 21, 2013