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: December 5, 2014
Last verified: December 2014
  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)
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

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Pain Scale on Numeric Rating Scale (NRS) (1 to 10) [ Time Frame: Less than 10 minutes after stream application. ] [ Designated as safety issue: No ]
    NRS scale: 0-10 ; No pain (0) - (5) moderate pain - Worst pain (10)


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.

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, adults (excluding the very old, > 80 years old) 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:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient needing venipuncture ("blood draw') but not intravenous cannulation
  • Adult 21 years and older up to and and including 80 years old
  • Stable patient
  • Mentally competent patient able to understand the consent form

Exclusion Criteria:

  • Patients with any allergies to the spray components (e.g. 1,1,1,3,3 pentafluoropropane or 1,1,1,2, tetrafluoroethane )
  • Critically ill or unstable (e.g. sepsis or shock)
  • Extremes of age: geriatric (> 80 years) or pediatric ( < 21 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 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: NCT01712776

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
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
Results First Received: January 9, 2014
Last Updated: December 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Vapocoolant

ClinicalTrials.gov processed this record on March 30, 2015