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

NCT01670487 | Completed Results DMC

• 1 other identifier: GEB-02
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Keywords

Vapocoolant

Outcome Measures

Primary Outcomes (1)

• Pain Score on the Numeric Rating Scale (NRS)

  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.

  pain of intravenous catheter placement.

Study Arms (2)

Vapocoolant (Pain Ease Medium Stream)

ACTIVE COMPARATOR

Application of the stream steadily 4 to 10 seconds onto the cannulation site.

Nature's Tears

PLACEBO COMPARATOR

Apply sterile water (see manufacturer above) steadily 4-10 seconds onto the cannulation site.

Device: Sterile water

Interventions

Vapocoolant DEVICE

Topical stream of 4 to 10 seconds duration to skin

Also known as: Pain Ease stream

Sterile water DEVICE

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

Also known as: Nature's Tears by Bio-Logic Aqua Technologies

Nature's Tears

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Gebauer Company: collaborator

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (8)

• 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.

  PMID: 19208703 BACKGROUND

• Page DE, Taylor DM. Vapocoolant spray vs subcutaneous lidocaine injection for reducing the pain of intravenous cannulation: a randomized, controlled, clinical trial. Br J Anaesth. 2010 Oct;105(4):519-25. doi: 10.1093/bja/aeq198. Epub 2010 Aug 3.

  PMID: 20682573 BACKGROUND

• Biro P, Meier T, Cummins AS. Comparison of topical anaesthesia methods for venous cannulation in adults. Eur J Pain. 1997;1(1):37-42. doi: 10.1016/s1090-3801(97)90051-3.

  PMID: 15102427 BACKGROUND

• Hartstein BH, Barry JD. Mitigation of pain during intravenous catheter placement using a topical skin coolant in the emergency department. Emerg Med J. 2008 May;25(5):257-61. doi: 10.1136/emj.2006.044776.

  PMID: 18434455 BACKGROUND

• Baxter AL, Leong T, Mathew B. External thermomechanical stimulation versus vapocoolant for adult venipuncture pain: pilot data on a novel device. Clin J Pain. 2009 Oct;25(8):705-10. doi: 10.1097/AJP.0b013e3181af1236.

  PMID: 19920721 BACKGROUND

• Patterson P, Hussa AA, Fedele KA, Vegh GL, Hackman CM. Comparison of 4 analgesic agents for venipuncture. AANA J. 2000 Feb;68(1):43-51.

  PMID: 10876451 BACKGROUND

• Barbour T, O'Keefe S, Mace SE. Topical Refrigerant Spray for IVs: Patient/Provider Responses - Prospective, Double-blind, Randomized Study. West J Nurs Res. 2021 Aug;43(8):762-769. doi: 10.1177/0193945920976061. Epub 2020 Dec 8.

  PMID: 33292081 DERIVED

• Mace SE. Prospective, double blind, randomized, controlled trial comparing vapocoolant spray versus placebo spray in adults undergoing intravenous cannulation. Scand J Pain. 2017 Oct;17:8-15. doi: 10.1016/j.sjpain.2017.06.002. Epub 2017 Jul 10.

  PMID: 28850378 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Sharon Mace
• Organization: Cleveland Clinic

maces@ccf.org

216-445-4598

Study Officials

• Sharon E. Mace, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician & Research Director, Emergency Services Institute

Study Record Dates

• First Submitted: August 13, 2012
• First Posted: August 22, 2012
• Study Start: October 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 27, 2025
• Results First Posted: September 21, 2016

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)