Pain
Conditions
Keywords
Vapocoolant
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.
Interventions
DEVICEVapocoolant (Pain Ease)
Topical stream 4-10 seconds duration to skin.
Topical stream 4-10 seconds duration to skin
Sponsors
Gebauer Company
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scale on Numeric Rating Scale (NRS) ( 0 to 10) | Less than 10 minutes after stream application. | NRS scale: 0-10 ; No pain (0) - (5) moderate pain - Worst pain (10) |
Countries
United States
Participant flow
Recruitment details
emergency department patients
Participants by arm
| Arm | Count |
|---|---|
| Vapocoolant (Pain Ease Medium Stream ) Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.
Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin. | 50 |
| Nature's Tears Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.
Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin. | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Vapocoolant (Pain Ease Medium Stream ) | Nature's Tears | Total |
|---|---|---|---|
| Age, Continuous | 52.98 years STANDARD_DEVIATION 13.42 | 51.48 years STANDARD_DEVIATION 11.48 | 52.23 years STANDARD_DEVIATION 12.45 |
| Region of Enrollment United States | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 31 Participants | 23 Participants | 54 Participants |
| Sex: Female, Male Male | 19 Participants | 27 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 50 | 1 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Pain Scale on Numeric Rating Scale (NRS) ( 0 to 10)
NRS scale: 0-10 ; No pain (0) - (5) moderate pain - Worst pain (10)
Time frame: Less than 10 minutes after stream application.
Population: equal numbers in both groups by randomization to 50 in each group to look at NRS by change of 2 in NRS scale between the 2 groups
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vapocoolant (Pain Ease Medium Stream ) | Pain Scale on Numeric Rating Scale (NRS) ( 0 to 10) | 1.7 units on a scale | Standard Deviation 2.3 |
| Nature's Tears | Pain Scale on Numeric Rating Scale (NRS) ( 0 to 10) | 4.7 units on a scale | Standard Deviation 2.9 |