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

NCT04207710 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 12932
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spray; Pain; Safety Issues

Keywords

Pain Ease; Ethyl Chloride; Safety; Topical anesthetic; ChloraPrep; Topical refrigerant; Microbial growth

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (4)

Microbial growth on wrist after application of Gebauer's Ethyl Chloride

EXPERIMENTAL

An area of skin on the wrist will be swabbed before and after Chloraprep application, and then each area will be swabbed again after application of Gebauer's Ethyl Chloride topical refrigerant spray. The bacterial growth prior to and after numbing spray application will be evaluated, based on the number of colony forming units that are present.

Drug: Gebauer's Ethyl Chloride

Microbial growth on lower back after application of Gebauer's Ethyl Chloride

EXPERIMENTAL

An area of skin on the lower back will be swabbed before and after Chloraprep application, and then each area will be swabbed again after application of Gebauer's Ethyl Chloride topical refrigerant spray. The bacterial growth prior to and after numbing spray application will be evaluated, based on the number of colony forming units that are present.

Drug: Gebauer's Ethyl Chloride

Microbial growth on wrist after application of Gebauer's Pain Ease

EXPERIMENTAL

An area of skin on the wrist will be swabbed before and after Chloraprep application, and then each area will be swabbed again after application of Gebauer's Pain Ease topical refrigerant spray. The bacterial growth prior to and after numbing spray application will be evaluated, based on the number of colony forming units that are present.

Drug: Gebauer's Pain Ease Top Aerosol Mist Spray

Microbial growth on lower back after application of Gebauer's Pain Ease

EXPERIMENTAL

An area of skin on the lower back will be swabbed before and after Chloraprep application, and then each area will be swabbed again after application of Gebauer's Pain Ease topical refrigerant spray. The bacterial growth prior to and after numbing spray application will be evaluated, based on the number of colony forming units that are present.

Drug: Gebauer's Pain Ease Top Aerosol Mist Spray

Interventions

Gebauer's Pain Ease Top Aerosol Mist Spray DRUG

Topical refrigerant spray

Also known as: Pain Ease

Microbial growth on lower back after application of Gebauer's Pain Ease; Microbial growth on wrist after application of Gebauer's Pain Ease

Gebauer's Ethyl Chloride DRUG

Topical refrigerant spray

Also known as: Ethyl Chloride

Microbial growth on lower back after application of Gebauer's Ethyl Chloride; Microbial growth on wrist after application of Gebauer's Ethyl Chloride

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Henry Ford employees

You may not qualify if:

• People with infections at the site of prep
• People with history of hypersensitivity to numbing sprays or chloraprep

Sponsors & Collaborators

• Henry Ford Health System: lead
• Gebauer Company: collaborator

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Related 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.

  PMID: 26044395 BACKGROUND

• 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.

  PMID: 22257997 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

pain ease refrigerant; Ethyl Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydrocarbons, Chlorinated; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Director of Research, Department of Anesthesiology
• Organization: Henry Ford Health

knowak2@hfhs.org

313-771-7128

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The microbiology lab staff culturing and analyzing the samples for microbial growth will not know what type of treatment each sample received. Each sample will only be labelled with a numerical string. The research staff will have a spreadsheet to determine which numerical string corresponds with which treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 72 participants will have an area of skin on the wrist and lower back swabbed three times each. First, the untreated patch of skin will be swabbed, then it will be treated with ChloraPep and swabbed, then Pain Ease spray will be applied and the area will be swabbed again. The same process will be performed using Ethyl Chloride spray instead of Pain Ease on the opposite wrist and adjacent area on the lower back. The bacterial growth will be compared amongst the different treatments, based on the number of colony forming units that are present.

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 23, 2019
• Study Start: January 26, 2021
• Primary Completion: February 25, 2022
• Study Completion: February 25, 2022
• Last Updated: March 4, 2024
• Results First Posted: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)