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

The Cleveland Clinic300 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

300

Conditions

Pain

Interventions

VapocoolantDEVICE

Topical stream of 4 to 10 seconds duration to skin

Sterile waterDEVICE

Topical intervention of sterile water stream 4 to 10 seconds to skin.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Cleveland Clinic

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

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.

Data from ClinicalTrials.gov

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