Pain
Conditions
Keywords
Vapocoolant
Brief 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.
Detailed 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.
Interventions
DEVICEVapocoolant
Topical stream of 4 to 10 seconds duration to skin
DEVICESterile water
Topical intervention of sterile water stream 4 to 10 seconds to skin.
Sponsors
Gebauer Company
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score on the Numeric Rating Scale (NRS) | pain of intravenous catheter placement. | Numeric rating scale (NRS) 0-10 : 0 (no pain) - 5 (moderate pain) - 10 (worst pain). Scores to be utilized after stream device applied and after intravenous catheter placement. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vapocoolant (Pain Ease Medium Stream) Applied Vapoccolant in a topical stream of 4 to 10 seconds duration to skin | 150 |
| Nature's Tears Applied Nature's Tears in a topical stream of 4 to 10 seconds duration to skin | 150 |
| Total | 300 |
Baseline characteristics
| Characteristic | Vapocoolant (Pain Ease Medium Stream) | Nature's Tears | Total |
|---|---|---|---|
| Age, Continuous | 52 years | 50 years | 51 years |
| Sex: Female, Male Female | 94 Participants | 64 Participants | 158 Participants |
| Sex: Female, Male Male | 56 Participants | 86 Participants | 142 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 150 | 2 / 150 |
| serious Total, serious adverse events | 0 / 150 | 0 / 150 |
Outcome results
Primary
Pain Score on the Numeric Rating Scale (NRS)
Numeric rating scale (NRS) 0-10 : 0 (no pain) - 5 (moderate pain) - 10 (worst pain). Scores to be utilized after stream device applied and after intravenous catheter placement.
Time frame: pain of intravenous catheter placement.
Population: adults undergoing placement of an intravenous line in the emergency department
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vapocoolant (Pain Ease Medium Stream) | Pain Score on the Numeric Rating Scale (NRS) | 2.3 NRS | Standard Deviation 2.4 |
| Placebo (Nature's Tears) | Pain Score on the Numeric Rating Scale (NRS) | 4.3 NRS | Standard Deviation 3 |