Safety of Gebauer's Pain Ease and Gebauer's Ethyl Chloride

Pain Clinical Trial

Official title:

Study to Determine the Safety of Gebauer's Ethyl Chloride and Gebauer's Pain Ease Sprays When Used Following ChloraPrep for Invasive Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04207710
• Other study ID #: 12932
• Status: Completed
• Phase: Phase 4
• Start date: January 26, 2021
• Est. completion date: February 25, 2022

Study information

• Verified date: March 2024
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to determine if Gebauer's Pain Ease or Gebauer's Ethyl Chloride topical anesthetic sprays are safe for use as numbing agents prior to placing epidurals and arterial lines, based on whether they introduce increased microbial growth after application to skin. Due to the recent national shortage of lidocaine, we hope to find a suitable alternative to lidocaine for topical analgesia when placing arterial lines and epidurals. Our hypothesis is that the sprays will not affect the sterility of the area. We will compare microbial growth from three subsequent swabs taken from a single area of skin on the wrist and lower back: one with no treatment, the second after treatment with ChloraPrep, and the third after applying one of the numbing sprays. If there is significantly higher growth in the swabs containing the topical anesthetic spray versus the ChloraPrep alone, this will indicate that the sprays introduce microbes to the sites of skin.

Description:

The purpose of this study is to determine whether Gebauer's Pain Ease and Ethyl Chloride topical anesthetic sprays are safe for application on the areas of skin where epidurals (lower back) and arterial lines (wrist) are placed, based on whether they introduce microbial growth to these areas. The investigators will compare microbial growth by swabbing both of these skin sites following: 1) no treatment 2) ChloraPrep treatment and 3) ChloraPrep plus numbing spray (Ethyl Chloride or Pain Ease) treatment. The cultures will then be incubated to test for anaerobic bacteria, aerobic bacteria, and mold growth. The microbial growth will be compared between the three treatment groups based on the number of colony forming units present.

Funding for the project will be from the manufacturer of the numbing sprays, Gebauer Company.

Based on power analysis, for each of the numbing sprays, a total of 72 subjects must be enrolled, with 6 swabs taken per subject (untreated, ChloraPrep, and topical anesthetic spray samples will be taken from both the wrist and lower back of each subject). A sample size of 72 pairs achieves 80 % power to detect an odds ratio of 24 using a two-sided McNemar test with a significance level of 0.05.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 25, 2022
• Est. primary completion date: February 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Henry Ford employees

Exclusion Criteria:

• People with infections at the site of prep

• People with history of hypersensitivity to numbing sprays or chloraprep

Related Conditions & MeSH terms

• Pain
• Safety Issues
• Spray

Intervention

Drug:
• Gebauer's Pain Ease Top Aerosol Mist Spray
Topical refrigerant spray
• Gebauer's Ethyl Chloride
Topical refrigerant spray

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Henry Ford Health System	Gebauer Company

Country where clinical trial is conducted

United States, 

References & Publications (2)

Mlynek K, Lyahn H, Richards B, Schleicher W, Bassiri Gharb B, Procop G, Tuohy M, Zins J. Skin Sterility After Application of a Vapocoolant Spray Part 2. Aesthetic Plast Surg. 2015 Aug;39(4):597-601. doi: 10.1007/s00266-015-0509-5. Epub 2015 Jun 5. — View Citation

Polishchuk D, Gehrmann R, Tan V. Skin sterility after application of ethyl chloride spray. J Bone Joint Surg Am. 2012 Jan 18;94(2):118-20. doi: 10.2106/JBJS.K.00229. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of Microbial Growth (1+ CFU)	Number of skin samples that were positive for bacterial growth following treatment with ChloraPrep and then application of a topical refrigerant spray (Gebauer's Ethyl Chloride or Gebauer's Pain Ease), when the area was swabbed and cultured for three days. A sample was considered positive if 1 or more colony forming units were present per swab.	Skin samples were swabbed within 20 seconds of Ethyl Chloride or Pain Ease application, and then swabs were cultured for 3 days before checking for the presence of CFU.