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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective,Randomized,Blinded, Comparative,Efficacy and Safety Trial of Vapocoolant (Pain Ease Medium Stream) for Intravenous Cannulation in Emergency Department Patients.

Conditions
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Pain

Intervention / Treatment
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* Device: Vapocoolant
* Device: Sterile water


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vapocoolant (Pain Ease Medium Stream)<br>Application of the stream steadily 4 to 10 seconds onto the cannulation site. | Device: Vapocoolant<br>* Topical stream of 4 to 10 seconds duration to skin<br>* Other names: Pain Ease stream;|
| Placebo Comparator: Nature's Tears<br>Apply sterile water (see manufacturer above) steadily 4-10 seconds onto the cannulation site. | Device: Sterile water<br>* Topical intervention of sterile water stream 4 to 10 seconds to skin.<br>* Other names: Nature's Tears by Bio-Logic Aqua Technologies;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | pain of intravenous catheter placement. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vapocoolant