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OpenTrials
Completed

NCT Number: NCT01712776

Vapocoolant (Pain Ease) Use for Venipuncture

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vapocoolant (Pain Ease)

Device

Topical stream 4-10 seconds duration to skin.

Other names: Pain Ease Stream

Nature's Tears Sterile Water

Device

Topical stream 4-10 seconds duration to skin

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Gebauer Company

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 24, 2012
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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