Vapocoolant (Pain Ease) Use for Venipuncture

NCT ID: NCT01712776

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-02-29

Brief Summary

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

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vapocoolant (Pain Ease Medium Stream )

Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.

Group Type: ACTIVE_COMPARATOR

Vapocoolant (Pain Ease)

Intervention Type: DEVICE

Topical stream 4-10 seconds duration to skin.

Nature's Tears Sterile Water

Application of sterile water stream (nature's tears) for 4-10 seconds onto the venipuncture site.

Group Type: PLACEBO_COMPARATOR

Nature's Tears Sterile Water

Intervention Type: DEVICE

Topical stream 4-10 seconds duration to skin

Interventions

Vapocoolant (Pain Ease)

Topical stream 4-10 seconds duration to skin.

Intervention Type: DEVICE

Nature's Tears Sterile Water

Topical stream 4-10 seconds duration to skin

Intervention Type: DEVICE

Other Intervention Names

Pain Ease Stream

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gebauer Company

NETWORK

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Sharon Mace

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sharon E. Mace, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 18591524 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19208703 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26979261 (View on PubMed)

Other Identifiers

GEB-01

Identifier Type: -

Identifier Source: org_study_id