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

Phase 4

Completed

• Conditions: Pain
• Interventions: Device: Vapocoolant; Device: Sterile water

• Registration Number: NCT01670487
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study First Submitted: 2012-08-13
• Study First Submitted QC: 2012-08-20
• Study First Posted: 2012-08-22
• Study Start: 2012-10
• Primary Completion: 2014-11
• Study Completion: 2014-12
• Results First Submitted: 2016-02-01
• Status Verified: 2016-07
• Results First Submitted QC: 2016-07-29
• Last Update Submitted: 2016-07-29
• Results First Posted: 2016-09-21
• Last Update Posted: 2016-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vapocoolant (Pain Ease Medium Stream)	Vapocoolant	Application of the stream steadily 4 to 10 seconds onto the cannulation site.
Nature's Tears	Sterile water	Apply sterile water (see manufacturer above) steadily 4-10 seconds onto the cannulation site.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States