N/A N=300 Randomized Quadruple-blind Supportive Care

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

Pain

Bottom Line

View on ClinicalTrials.gov: NCT01670487 ↗

Enrolled (actual)

300

Serious AEs

0.0%

Results posted

Sep 2016

Primary outcome: Primary: Pain Score on the Numeric Rating Scale (NRS) — 2.3; 4.3 NRS

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Vapocoolant (Device); Sterile water (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Cleveland Clinic
Primary completion: Nov 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Score on the Numeric Rating Scale (NRS)	2.3; 4.3	—

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.

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.
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.

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Data sourced from ClinicalTrials.gov (NCT01670487). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.