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OpenTrials
Completed

NCT Number: NCT01670487

Vapocoolant (Pain Ease Medium Stream) for Intravenous Lines in Emergency Department Patients

To determine the efficacy and safety of vapocoolant stream (Pain Ease Medium Stream ) in decreasing the pain of intravenous cannulation.

To compare vapocoolant stream (Pain Ease medium Stream) with control (e.g. sterile water) stream.

Completed

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

Vapocoolant sprays have been used to decrease the pain associated with painful medical procedures such as immunizations, needle aspirations, injections, venipuncture and intravenous cannulation. In general, vapocoolant sprays , have been found to be effective in decreasing the pain of various medical procedures. Moreover, the use of vapocoolant sprays ,unlike other local anesthetics , such as infiltrative lidocaine , is not associated with a painful injection and does affect the success rate of the procedure including intravenous cannulation and may even increase the success rate of the intravenous cannulation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients needing intravenous cannulation
  • Adults age 18 years equal or greater than.
  • Stable patient
  • Mentally competent patient able to understand the consent form

Exclusion criteria

  • Patients with any allergies to the spray components ( e.g.1,1,3,3, pentafluoropropane or 1,1,1,2 tetrafluoroethane )
  • Critically ill or unstable patient (e.g. sepsis or shock)
  • Infants and children of age , <18 years.
  • Pregnant
  • Intravenous cannulation site located in area of compromised blood supply. (ex: patients with Peripheral Vascular Disease , Raynaud's disease, gangrene, Buerger's disease)
  • Intravenous cannulation site located in area of insensitive skin; such as , 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.

Treatment and study plan

Vapocoolant

Device

Topical stream of 4 to 10 seconds duration to skin

Other names: Pain Ease stream

Sterile water

Device

Topical intervention of sterile water stream 4 to 10 seconds to skin.

Other names: Nature's Tears by Bio-Logic Aqua Technologies

Primary outcomes

  1. Pain Score on the Numeric Rating Scale (NRS)

    Time frame: pain of intravenous catheter placement.

    Numeric rating scale (NRS) 0-10 : 0 (no pain) - 5 (moderate pain) - 10 (worst pain). Scores to be utilized after stream device applied and after intravenous catheter placement.

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 Intravenous Cannulation in Emergency Department Patients.

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 22, 2012
Registry last updated
Oct 27, 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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