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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01670487
• Other study ID #: GEB-02
• Status: Completed
• Phase: Phase 4
• First received: August 13, 2012
• Last updated: December 5, 2014
• Start date: October 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• Vapocoolant
Topical stream of 4 to 10 seconds duration to skin
• Sterile water
Topical intervention of sterile water stream 4 to 10 seconds to skin.

Locations

Country	Name	City	State
United States	The Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Gebauer Company

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score on the visual analog scale	Numeric rating scale (VAS) 0-10 : 0 (no pain) - 5 (moderate pain) - 10 (worst pain). Scores to be utilized after stream device applied and after intravenous catheter placement.	<1 minute after stream device application, , 1 minute after intravenous catheter placement.	No
Secondary	Patient satisfaction with the procedure	Patient self reported satisfaction with the procedure using an eight item questionnaire developed specifically for the study.	Within one hour of intravenous cannulation.	No
Secondary	Health Care Provider satisfaction with the procedure	Health Care provider self reported satisfaction with the procedure using a six item questionnaire developed specifically for the study	Within one hour of intravenous cannulation.	No
Secondary	Ease of insertion of intravenous catheter placement	Questionnaire: Success in one attempt; number of attempts ; location of intravenous catheter placement;Health care provider inserting IV catheter ( Registered Nurse, paramedic, Emergency Medical Technician, Nurse Practitioner /Physician Assistant , Medical Doctor ); years of experience of performing IV's	Duration of time to establish an IV catheter in the Emergency Department	No
Secondary	Number of participants with adverse events.	Utilized as a measure of safety and tolerability.Skin assessment at site of post stream device application /Clinical assessment : description of skin at site: redness, blanching, change in skin color pigmentation. Photograph of site to confirm clinical description.	Within 1 hour after application of the device	Yes