CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 72 enrolled
Drug / intervention
Gebauer's Pain Ease Top Aerosol Mist Spray +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04207710
NCT04207710Phase 4Completed

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

Henry Ford Health System·interventional·Posted Dec 23, 2019·Updated Mar 4, 2024

In Brief

A Phase 4 clinical trial evaluating Gebauer's Pain Ease Top Aerosol Mist Spray and Gebauer's Ethyl Chloride for Spray and 2 related conditions. Completed, enrolled 72 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsGebauer Company

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedDec 23, 2019
Enrollment StartJan 26, 2021
Primary CompletionFeb 25, 2022
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 6.5 years ago

Interventions

Gebauer's Pain Ease Top Aerosol Mist Spraydrug

Topical refrigerant spray

Gebauer's Ethyl Chloridedrug

Topical refrigerant spray