Clinical trial NCT01712776: Vapocoolant (Pain Ease) Use for Venipuncture
Official title: Prospective, Randomized, Blinded,Comparative Efficacy and Safety Trial of Vapocoolant (Pain Ease Medium Stream) for Venipuncture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Vapocoolant
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Gebauer Company
First posted: 2012-10-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the efficacy and safety of vapocoolant spray (Pain Ease Medium Stream) in decreasing the pain of venipuncture ("blood draw")

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Scale on Numeric Rating Scale (NRS) ( 0 to 10)
timeFrame: Less than 10 minutes after stream application.
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Sharon E. Mace, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: Mace SE. Prospective, randomized, double-blind controlled trial comparing vapocoolant spray vs placebo spray in adults undergoing venipuncture. Am J Emerg Med. 2016 May;34(5):798-804. doi: 10.1016/j.ajem.2016.01.002. Epub 2016 Jan 7.