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NCT04207710 · ClinicalTrials.gov registry record · Phase 4
Safety of Gebauer's Pain Ease and Gebauer's Ethyl Chloride
A Phase 4 study, sponsored by Henry Ford Health System.
- Completed
- Registry status
- Phase 4
- Development phase
- 72
- Enrollment target
NCT04207710: Completed Phase 4 study, sponsored by Henry Ford Health System.
NCT04207710 is a Phase 4 study that has completed, run by Henry Ford Health System. The registered enrollment target is 72 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04207710, a Phase 4 study, has completed, sponsored by Henry Ford Health System.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 72 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Gebauer's Pain Ease Top Aerosol Mist Spray
- DRUG Gebauer's Ethyl Chloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2021-01-26 |
| Est. Completion | 2022-02-25 |
| Phase | Phase 4 |
What the finished NCT04207710 record still lists
NCT04207710 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Gebauer's Pain Ease Top Aerosol Mist Spray is the first listed.
NCT04207710 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04207710 about?
NCT04207710 is a clinical study titled "Safety of Gebauer's Pain Ease and Gebauer's Ethyl Chloride". 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...
What is the current status of trial NCT04207710?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 72 participants. The study started on 2021-01-26. Estimated completion is 2022-02-25.
What interventions are being tested in trial NCT04207710?
The interventions under investigation include: Gebauer's Pain Ease Top Aerosol Mist Spray (DRUG), Gebauer's Ethyl Chloride (DRUG).
Who is sponsoring clinical trial NCT04207710?
This trial is sponsored by Henry Ford Health System, which has 234 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04207710's enrollment target sits among peer trials
72 1035th of 2000 higher than 961 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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