Skin Refrigerant to Reduce the Pain Associated With IV Insertion

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02499965
• Other study ID #: 404187-2
• Status: Completed
• Phase: N/A
• First received: July 14, 2015
• Last updated: July 15, 2015
• Start date: April 2015
• Est. completion date: May 2015

Study information

• Verified date: July 2015
• Source: Brooke Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Ethyl Chloride Topical Aerosol Anesthetic
Sprayed on the skin for 5-8 seconds immediately before IV cannulation
• Nature's Tears Sterile Water
Sprayed on the skin for 5-8 seconds immediately before IV cannulation

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	Fort Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Brooke Army Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Ordinal pain scale (1-10)	1 minute	No
Secondary	Preferred product	Categorical selection of preferred product for use on self prior to IV placement	1 minute	No
Secondary	Desire to use on self in future	Binary (yes, no) desire to use on self prior to IV placement in future	1 minute	No
Secondary	Desire to use on patients in future	Binary (yes, no) desire to use on patients prior to IV placement in future	1 minute	No
Secondary	Likelihood to use on patients in future	5 point likert scale ranging from "very unlikely" to "very likely"	1 minute	No