Phase 4
N=72
Safety of Gebauer's Pain Ease and Gebauer's Ethyl Chloride
Spray · Pain · Safety Issues
Bottom Line
View on ClinicalTrials.gov: NCT04207710 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Presence of Microbial Growth (1+ CFU) — 2; 1; 1; 1 Number of samples with 1+ CFU — p=0.317
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Gebauer's Pain Ease Top Aerosol Mist Spray (Drug); Gebauer's Ethyl Chloride (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Henry Ford Health System
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Presence of Microbial Growth (1+ CFU) |
2; 1; 1; 1; 1; 0 | 0.317 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04207710). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.