NCT01712776

Brief Summary

To determine the efficacy and safety of vapocoolant spray (Pain Ease Medium Stream) in decreasing the pain of venipuncture ("blood draw")

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2012

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 24, 2012

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

December 11, 2014

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

10 months

First QC Date

October 4, 2012

Results QC Date

January 9, 2014

Last Update Submit

August 11, 2025

Conditions

Pain

Keywords

Vapocoolant

Outcome Measures

Primary Outcomes (1)

  • Pain Scale on Numeric Rating Scale (NRS) ( 0 to 10)

    NRS scale: 0-10 ; No pain (0) - (5) moderate pain - Worst pain (10)

    Less than 10 minutes after stream application.

Study Arms (2)

Vapocoolant (Pain Ease Medium Stream )

ACTIVE COMPARATOR

Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.

Device: Vapocoolant (Pain Ease)

Nature's Tears Sterile Water

PLACEBO COMPARATOR

Application of sterile water stream (nature's tears) for 4-10 seconds onto the venipuncture site.

Device: Nature's Tears Sterile Water

Interventions

Vapocoolant (Pain Ease)DEVICE

Topical stream 4-10 seconds duration to skin.

Also known as: Pain Ease Stream
Vapocoolant (Pain Ease Medium Stream )
Nature's Tears Sterile WaterDEVICE

Topical stream 4-10 seconds duration to skin

Nature's Tears Sterile Water

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient needing venipuncture ("blood draw') but not intravenous cannulation
  • Adult 18 years and older up to and and including 80 years old
  • Stable patient
  • Mentally competent patient able to understand the consent form

You may not qualify if:

  • Patients with any allergies to the spray components (e.g. 1,1,1,3,3 pentafluoropropane or 1,1,1,2, tetrafluoroethane )
  • Critically ill or unstable (e.g. sepsis or shock)
  • Extremes of age: geriatric (\> 80 years) or pediatric ( \< 18 years old)
  • Pregnant
  • Venipuncture site located in area of compromised blood supply. Examples include : patients with peripheral vascular disease, gangrene, Raynaud's disease, Buerger's disease.
  • Venipuncture site located in area of insensitive skin; 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.
  • Prior experience with vapocoolant spray
  • Currently in another research trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (3)

  • Farion KJ, Splinter KL, Newhook K, Gaboury I, Splinter WM. The effect of vapocoolant spray on pain due to intravenous cannulation in children: a randomized controlled trial. CMAJ. 2008 Jul 1;179(1):31-6. doi: 10.1503/cmaj.070874.

    PMID: 18591524BACKGROUND

  • Hijazi R, Taylor D, Richardson J. Effect of topical alkane vapocoolant spray on pain with intravenous cannulation in patients in emergency departments: randomised double blind placebo controlled trial. BMJ. 2009 Feb 10;338:b215. doi: 10.1136/bmj.b215.

    PMID: 19208703BACKGROUND

  • Mace SE. Prospective, randomized, double-blind controlled trial comparing vapocoolant spray vs placebo spray in adults undergoing venipuncture. Am J Emerg Med. 2016 May;34(5):798-804. doi: 10.1016/j.ajem.2016.01.002. Epub 2016 Jan 7.

    PMID: 26979261DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

This study enrolled only adults. No pediatric patients were enrolled. However, an earlier study by Farion KJ et al in CMAJ in 2008 found that the use of a vapocoolant (pain-ease) significantly decreased the pain of intravenous cannulation in children

Results Point of Contact

Title
Dr. Sharon E. Mace, Director of Research, ESI
Organization
Cleveland Clinic
maces@ccf.org
(216) 445-4598

Study Officials

  • Sharon E. Mace, M.D.

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 4, 2012

First Posted

October 24, 2012

Study Start

April 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

August 29, 2025

Results First Posted

December 11, 2014

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)