Vapocoolant (Pain Ease) Use for Venipuncture

Prospective, Randomized, Blinded,Comparative Efficacy and Safety Trial of Vapocoolant (Pain Ease Medium Stream) for Venipuncture

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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Device: Vapocoolant (Pain Ease); Device: Nature's Tears Sterile Water

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scale on Numeric Rating Scale (NRS) ( 0 to 10)	NRS scale: 0-10 ; No pain (0) - (5) moderate pain - Worst pain (10)	Less than 10 minutes after stream application.

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: Gebauer Company
• Investigators: Principal Investigator: Sharon E. Mace, M.D., The Cleveland Clinic

Publications and helpful links

General Publications

• Farion KJ, Splinter KL, Newhook K, Gaboury I, Splinter WM. The effect of vapocoolant spray on pain due to intravenous cannulation in children: a randomized controlled trial. CMAJ. 2008 Jul 1;179(1):31-6. doi: 10.1503/cmaj.070874.
• Hijazi R, Taylor D, Richardson J. Effect of topical alkane vapocoolant spray on pain with intravenous cannulation in patients in emergency departments: randomised double blind placebo controlled trial. BMJ. 2009 Feb 10;338:b215. doi: 10.1136/bmj.b215.
• Mace SE. Prospective, randomized, double-blind controlled trial comparing vapocoolant spray vs placebo spray in adults undergoing venipuncture. Am J Emerg Med. 2016 May;34(5):798-804. doi: 10.1016/j.ajem.2016.01.002. Epub 2016 Jan 7.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: October 4, 2012
• First Submitted That Met QC Criteria: October 23, 2012
• First Posted (Estimated): October 24, 2012

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Vapocoolant
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain
• Other Study ID Numbers: GEB-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO