Vapocoolant (Pain Ease) Use for Venipuncture

Phase 4

Completed

• Conditions: Pain
• Interventions: Device: Nature's Tears Sterile Water; Device: Vapocoolant (Pain Ease)

• Registration Number: NCT01712776
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Study First Submitted: 2012-10-04
• Study First Submitted QC: 2012-10-23
• Study First Posted: 2012-10-24
• Results First Submitted: 2014-01-09
• Results First Submitted QC: 2014-12-05
• Results First Posted: 2014-12-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nature's Tears Sterile Water	Nature's Tears Sterile Water	Application of sterile water stream (nature's tears) for 4-10 seconds onto the venipuncture site.
Vapocoolant (Pain Ease Medium Stream )	Vapocoolant (Pain Ease)	Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States