Skin Refrigerant to Reduce the Pain Associated With IV Insertion

The Use of a Topical Anesthetic Skin Refrigerant to Reduce the Pain Associated With Intravenous Catheter Insertion, A Double Blinded, Patient/Placebo Controlled, Study

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Ethyl Chloride Topical Aerosol Anesthetic; Drug: Nature's Tears Sterile Water

Detailed Description

We recruited 38 emergency department healthcare providers (doctors, physician assistants, nurses and medics) to receive a total of two separate IV canulations - one in one arm and the other in the other. One IV canulation would be pretreated with Ethyl Chloride topical anesthetic (the study product) and the other would be pre-treated with a placebo (sterile water in an aerosol can). Both the participants and the nurses, PAs and medics who placed the IVs were blinded as to which was the Ethyl Chloride and which was the placebo. After the IVs were placed the participants were asked to rate the pain of IV canulation on a scale of 1 to 10 for each of the pre-treatments, to state which one they believed to be superior in reducing the pain of receiving the IV, to state whether or not they would like the intervention that they rated as superior to be used on themselves and finally how likely they were on a 5 point scale to incorporate the intervention they rated as superior into their future practice.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • Brooke Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. History of hypersensitivity to Ethyl Chloride.
2. Break, or swollen in the skin at the proposed IV site.
3. Pregnancy or lactating female.
4. Recent tattoo in either of the two proposed anatomical areas for IV cannulation.
5. Skin infection in either of the two proposed anatomical areas for IV cannulation.
6. Missing a contralateral limb to place the second IV.

7. 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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Topical Ethyl Chloride (Product B); Ethyl Chloride Topical Aerosol Anesthetic applied to arm	Drug: Ethyl Chloride Topical Aerosol Anesthetic; Sprayed on the skin for 5-8 seconds immediately before IV cannulation; Other Names: Study Device or Product B
Placebo Comparator: Topical Sterile Water (Product A); Nature's Tears Sterile water in an aerosol can	Drug: Nature's Tears Sterile Water; Sprayed on the skin for 5-8 seconds immediately before IV cannulation; Other Names: Placebo or Product A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Ordinal pain scale (1-10)	1 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preferred product	Categorical selection of preferred product for use on self prior to IV placement	1 minute
Desire to use on self in future	Binary (yes, no) desire to use on self prior to IV placement in future	1 minute
Desire to use on patients in future	Binary (yes, no) desire to use on patients prior to IV placement in future	1 minute
Likelihood to use on patients in future	5 point likert scale ranging from "very unlikely" to "very likely"	1 minute

Collaborators and Investigators

• Sponsor: Brooke Army Medical Center
• Investigators: Principal Investigator: Kurt Fossum, MPAS, Brooke Army Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: July 14, 2015
• First Submitted That Met QC Criteria: July 15, 2015
• First Posted (Estimate): July 16, 2015

Study Record Updates

• Last Update Posted (Estimate): July 16, 2015
• Last Update Submitted That Met QC Criteria: July 15, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: IV cannulation; Pain Reduction; Ethyl Chloride; Topical Anesthetic
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Local; Anesthetics; Ethyl Chloride
• Other Study ID Numbers: 404187-2