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NCT04207710

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

Completed Phase 4 Results posted Last updated 4 March 2024
What this trial tests

Phase 4 trial testing Gebauer's Pain Ease Top Aerosol Mist Spray in Spray in 72 participants. Completed in 25 February 2022.

Timeline
26 January 2021
Primary endpoint
25 February 2022
25 February 2022

Quick facts

Lead sponsorHenry Ford Health System
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment72
Start date26 January 2021
Primary completion25 February 2022
Estimated completion25 February 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Henry Ford Health System — full company profile →

Who can join

Eligibility, any sex, with Spray or Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Presence of Microbial Growth (1+ CFU) Primary · 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.

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.

Samples with positive growth after application of ChloraPrep followed by topical refrigerant spray
GroupValue95% CI
Wrist, Gebauer's Ethyl Chloride2
Lower Back, Gebauer's Ethyl Chloride1
Wrist, Gebauer's Pain Ease1
Lower Back, Gebauer's Pain Ease1
Samples with positive growth after application of ChloraPrep
GroupValue95% CI
Wrist, Gebauer's Ethyl Chloride1
Lower Back, Gebauer's Ethyl Chloride0
Wrist, Gebauer's Pain Ease0
Lower Back, Gebauer's Pain Ease2
Samples with positive growth before ChloraPrep treatment (positive control)
GroupValue95% CI
Wrist, Gebauer's Ethyl Chloride68
Lower Back, Gebauer's Ethyl Chloride63
Wrist, Gebauer's Pain Ease65
Lower Back, Gebauer's Pain Ease49

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Layer-by-layer assembly: advancing skin repair, one layer at a time.
    Hasan E, Lewis CJ, Hernandez JG, Gentile P, et al · · 2025 · cited 5× · PMID 40303355 · DOI 10.1039/d4ra08115c

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04207710.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing