N/A
N=100
Vapocoolant (Pain Ease) Use for Venipuncture
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01712776 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Pain Scale on Numeric Rating Scale (NRS) ( 0 to 10) — 1.7; 4.7 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vapocoolant (Pain Ease) (Device); Nature's Tears Sterile Water (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Scale on Numeric Rating Scale (NRS) ( 0 to 10) |
1.7; 4.7 | — |
Summary
To determine the efficacy and safety of vapocoolant spray (Pain Ease Medium Stream) in decreasing the pain of venipuncture ("blood draw")
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
Data sourced from ClinicalTrials.gov (NCT01712776). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.