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Vapocoolant (Pain Ease) Use for Venipuncture

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.
ClinicalTrials.gov Identifier: NCT01712776
Recruitment Status : Completed
First Posted : October 24, 2012
Results First Posted : December 11, 2014
Last Update Posted : March 6, 2017
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Pain Device: Vapocoolant (Pain Ease) Device: Nature's Tears Sterile Water Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
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
Study Start Date : April 2011
Primary Completion Date : February 2012
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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)

Eligibility Criteria

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

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

United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Gebauer Company
Principal Investigator: Sharon E. Mace, M.D. The Cleveland Clinic
More Information

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 Posted: October 24, 2012    Key Record Dates
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:

Additional relevant MeSH terms:
Methyl salicylate
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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