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

Primary Purpose

Pain

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Vapocoolant

Sterile water

About this trial

This is an interventional supportive care trial for Pain focused on measuring Vapocoolant

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vapocoolant (Pain Ease Medium Stream)

Nature's Tears

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01670487

First Posted

August 13, 2012

Last Updated

July 29, 2016

Sponsor

The Cleveland Clinic

Collaborators

Gebauer Company

1. Study Identification

Unique Protocol Identification Number

NCT01670487

Brief Title

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

Official Title

Prospective,Randomized,Blinded, Comparative,Efficacy and Safety Trial of Vapocoolant (Pain Ease Medium Stream) for Intravenous Cannulation in Emergency Department Patients.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Cleveland Clinic

Collaborators

Gebauer Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain

Keywords

Vapocoolant

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vapocoolant (Pain Ease Medium Stream)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Nature's Tears

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Vapocoolant

Other Intervention Name(s)

Pain Ease stream

Intervention Description

Topical stream of 4 to 10 seconds duration to skin

Intervention Type

Device

Intervention Name(s)

Sterile water

Other Intervention Name(s)

Nature's Tears by Bio-Logic Aqua Technologies

Intervention Description

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

Primary Outcome Measure Information:

Title

Pain Score on the Numeric Rating Scale (NRS)

Description

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.

Time Frame

pain of intravenous catheter placement.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sharon E. Mace, M.D.

Organizational Affiliation

The Cleveland Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Cleveland Clinic

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

19208703

Citation

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.

Results Reference

background

PubMed Identifier

20682573

Citation

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.

Results Reference

background

PubMed Identifier

15102427

Citation

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.

Results Reference

background

PubMed Identifier

18434455

Citation

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.

Results Reference

background

PubMed Identifier

19920721

Citation

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.

Results Reference

background

PubMed Identifier

10876451

Citation

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.

Results Reference

background

PubMed Identifier

33292081

Citation

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.

Results Reference

derived

PubMed Identifier

28850378

Citation

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.

Results Reference

derived

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

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