NCT02499965

Brief Summary

The purpose of this study is to determine whether or not the pain of IV catheter insertion in the Emergency Department can be reduced significantly with the use of a rapid acting topical anesthetic spray and to determine whether or not healthcare providers who undergo such treatment are likely to endorse its use in their future practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable pain

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, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2015

Completed
Last Updated

July 16, 2015

Status Verified

July 1, 2015

Enrollment Period

1 month

First QC Date

July 14, 2015

Last Update Submit

July 15, 2015

Conditions

Pain

Keywords

Topical AnestheticEthyl ChloridePain ReductionIV cannulation

Outcome Measures

Primary Outcomes (1)

  • Pain

    Ordinal pain scale (1-10)

    1 minute

Secondary Outcomes (4)

  • Preferred product

    1 minute

  • Desire to use on self in future

    1 minute

  • Desire to use on patients in future

    1 minute

  • Likelihood to use on patients in future

    1 minute

Study Arms (2)

Topical Ethyl Chloride (Product B)

ACTIVE COMPARATOR

Ethyl Chloride Topical Aerosol Anesthetic applied to arm

Drug: Ethyl Chloride Topical Aerosol Anesthetic

Topical Sterile Water (Product A)

PLACEBO COMPARATOR

Nature's Tears Sterile water in an aerosol can

Drug: Nature's Tears Sterile Water

Interventions

Ethyl Chloride Topical Aerosol AnestheticDRUG

Sprayed on the skin for 5-8 seconds immediately before IV cannulation

Also known as: Study Device or Product B
Topical Ethyl Chloride (Product B)
Nature's Tears Sterile WaterDRUG

Sprayed on the skin for 5-8 seconds immediately before IV cannulation

Also known as: Placebo or Product A
Topical Sterile Water (Product A)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years of age
  • A healthcare worker who routinely orders or places IV catheters.
  • Consents to participate in the study.

You may not qualify if:

  • History of hypersensitivity to Ethyl Chloride.
  • Break, or swollen in the skin at the proposed IV site.
  • Pregnancy or lactating female.
  • Recent tattoo in either of the two proposed anatomical areas for IV cannulation.
  • Skin infection in either of the two proposed anatomical areas for IV cannulation.
  • Missing a contralateral limb to place the second IV.
  • Recent trauma to one of the upper extremities or any neuropathic or radicular condition that could affect the participant's perception of pain in the antecubital fossa of each arm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (8)

  • Fung S, Phadke CP, Kam A, Ismail F, Boulias C. Effect of topical anesthetics on needle insertion pain during botulinum toxin type A injections for limb spasticity. Arch Phys Med Rehabil. 2012 Sep;93(9):1643-7. doi: 10.1016/j.apmr.2012.03.012. Epub 2012 Mar 23.

    PMID: 22449552BACKGROUND

  • Mawhorter S, Daugherty L, Ford A, Hughes R, Metzger D, Easley K. Topical vapocoolant quickly and effectively reduces vaccine-associated pain: results of a randomized, single-blinded, placebo-controlled study. J Travel Med. 2004 Sep-Oct;11(5):267-72. doi: 10.2310/7060.2004.19101.

    PMID: 15544709BACKGROUND

  • Hartstein BH, Barry JD. Mitigation of pain during intravenous catheter placement using a topical skin coolant in the emergency department. Emerg Med J. 2008 May;25(5):257-61. doi: 10.1136/emj.2006.044776.

    PMID: 18434455BACKGROUND

  • 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

  • Costello M, Ramundo M, Christopher NC, Powell KR. Ethyl vinyl chloride vapocoolant spray fails to decrease pain associated with intravenous cannulation in children. Clin Pediatr (Phila). 2006 Sep;45(7):628-32. doi: 10.1177/0009922806291013.

    PMID: 16928840BACKGROUND

  • Ducharme, J. (2011). Acute Pain Management in Adults. In J. E. Tintinalli, J. S. Stapczynski, O. J. Ma, D. M. Cline, R. K. Cydulka, & G. D. Meckler, Tintinalli

    BACKGROUND

  • Fossum K, Love SL, April MD. Topical ethyl chloride to reduce pain associated with venous catheterization: a randomized crossover trial. Am J Emerg Med. 2016 May;34(5):845-50. doi: 10.1016/j.ajem.2016.01.039. Epub 2016 Feb 13.

    PMID: 26971823DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kurt Fossum, MPAS

    Brooke Army Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Major, USA

Study Record Dates

First Submitted

July 14, 2015

First Posted

July 16, 2015

Study Start

April 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

July 16, 2015

Record last verified: 2015-07

Locations

US(1)