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Vapocoolant (Pain Ease) Use for Venipuncture

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01712776
First Posted: October 24, 2012
Last Update Posted: March 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Gebauer Company
Information provided by (Responsible Party):
Sharon Mace, The Cleveland Clinic
  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: Nature's Tears Sterile Water Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Sharon Mace, The Cleveland Clinic:

Primary Outcome Measures:
  • Pain Scale on Numeric Rating Scale (NRS) ( 0 to 10) [ Time Frame: Less than 10 minutes after stream application. ]
    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 Sterile Water
Application of sterile water stream (nature's tears) for 4-10 seconds onto the venipuncture site.
Device: Nature's Tears Sterile Water
Topical stream 4-10 seconds duration to skin

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient needing venipuncture ("blood draw') but not intravenous cannulation
  • Adult 18 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 ( < 18 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.
  • Prior experience with vapocoolant spray
  • Currently in another research trial
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sharon Mace, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01712776     History of Changes
Other Study ID Numbers: GEB-01
First Submitted: October 4, 2012
First Posted: October 24, 2012
Results First Submitted: January 9, 2014
Results First Posted: December 11, 2014
Last Update Posted: March 6, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sharon Mace, The Cleveland Clinic:
Vapocoolant

Additional relevant MeSH terms:
Camphor
Menthol
Salicylates
Methyl salicylate
Anti-Infective Agents, Local
Anti-Infective Agents
Antipruritics
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action