Vapocoolant (Pain Ease Medium Stream) for Intravenous Lines in Emergency Department Patients

NeuroTherapia, Inc.

Status: Completed

Conditions: Pain

Treatments: Device: Sterile water; Device: Vapocoolant

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT01670487

GEB-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups, including a placebo group

Vapocoolant (Pain Ease Medium Stream)

Active Comparator group

Description:

Application of the stream steadily 4 to 10 seconds onto the cannulation site.

Nature's Tears

Placebo Comparator group

Description:

Apply sterile water (see manufacturer above) steadily 4-10 seconds onto the cannulation site.

Treatment:

Device: Sterile water