Prospective,Randomized,Blinded, Comparative,Efficacy and Safety Trial of Vapocoolant (Pain Ease Medium Stream) for Intravenous Cannulation in Emergency Department Patients.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pain
- Sponsor
- The Cleveland Clinic
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Pain Score on the Numeric Rating Scale (NRS)
- Status
- Completed
- Last Updated
- 6 months ago
Overview
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.
Investigators
Sharon Mace
Staff Physician & Research Director, Emergency Services Institute
The Cleveland Clinic
Eligibility Criteria
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.
- •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.
Outcomes
Primary Outcomes
Pain Score on the Numeric Rating Scale (NRS)
Time Frame: 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.