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

NCT ID: NCT01670487

Last Updated: 2025-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-12-31

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.

Detailed Description

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.

Conditions

Pain

Study Design

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

Study Groups

Vapocoolant (Pain Ease Medium Stream)

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

Group Type: ACTIVE_COMPARATOR

No interventions assigned to this group

Nature's Tears

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

Group Type: PLACEBO_COMPARATOR

Sterile water

Intervention Type: DEVICE

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

Interventions

Vapocoolant

Topical stream of 4 to 10 seconds duration to skin

Intervention Type: DEVICE

Sterile water

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

Intervention Type: DEVICE

Other Intervention Names

Pain Ease stream; Nature's Tears by Bio-Logic Aqua Technologies

Eligibility Criteria

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.

• 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

Staff Physician & Research Director, Emergency Services Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sharon E. Mace, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

The Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

References

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)

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.

Reference Type: BACKGROUND

PMID: 20682573 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15102427 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18434455 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19920721 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10876451 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33292081 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28850378 (View on PubMed)

Other Identifiers

GEB-02

Identifier Type: -

Identifier Source: org_study_id