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
  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:


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 April 17, 2014