Vapocoolant (Pain Ease) Use for Venipuncture

Pain Clinical Trial

Official title:

Prospective, Randomized, Blinded,Comparative Efficacy and Safety Trial of Vapocoolant (Pain Ease Medium Stream) for Venipuncture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01712776
• Other study ID #: GEB-01
• Status: Completed
• Phase: Phase 4
• First received: October 4, 2012
• Last updated: December 7, 2015
• Start date: April 2011
• Est. completion date: February 2012

Study information

• Verified date: December 2015
• 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 spray (Pain Ease Medium Stream) in decreasing the pain of venipuncture ("blood draw")

Description:

This is a prospective, randomized, blinded, comparator study. This study design is considered standard for establishing safety and efficacy data. Active treatment vapocoolant spray (Pain Ease Medium Stream) spray) will be used. There will be a placebo (sterile water) in this study. The population selected for this study, adults (excluding the very old, > 80 years old) represents a patient population that may benefit from vapocoolant spray. This is a patient population that according to the treating health care provider already requires venipuncture for "blood draw" but not intravenous cannulation. Because venipuncture is a painful procedure, vapocoolant may confer benefit for the relief of pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patient needing venipuncture ("blood draw') but not intravenous cannulation

• Adult 18 years and older up to and and including 80 years old

• Stable patient

• Mentally competent patient able to understand the consent form

Exclusion Criteria:

• Patients with any allergies to the spray components (e.g. 1,1,1,3,3 pentafluoropropane or 1,1,1,2, tetrafluoroethane )

• Critically ill or unstable (e.g. sepsis or shock)

• Extremes of age: geriatric (> 80 years) or pediatric ( < 18 years old)

• Pregnant

• Venipuncture site located in area of compromised blood supply. Examples include :

patients with peripheral vascular disease, gangrene, Raynaud's disease, Buerger's disease.

• Venipuncture site located in area of insensitive skin; 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.

• Prior experience with vapocoolant spray

• Currently in another research trial

Study Design

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

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• Vapocoolant (Pain Ease)
Topical stream 4-10 seconds duration to skin.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Gebauer Company

Country where clinical trial is conducted

United States, 

References & Publications (2)

Farion KJ, Splinter KL, Newhook K, Gaboury I, Splinter WM. The effect of vapocoolant spray on pain due to intravenous cannulation in children: a randomized controlled trial. CMAJ. 2008 Jul 1;179(1):31-6. doi: 10.1503/cmaj.070874. — 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scale on Numeric Rating Scale (NRS) ( 0 to 10)	NRS scale: 0-10 ; No pain (0) - (5) moderate pain - Worst pain (10)	Less than 10 minutes after stream application.	No