Pain, Safety Issues, Spray
Conditions
Keywords
Pain Ease, Ethyl Chloride, Safety, Topical anesthetic, ChloraPrep, Topical refrigerant, Microbial growth
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.
Detailed description
The purpose of this study is to determine whether Gebauer's Pain Ease and Ethyl Chloride topical anesthetic sprays are safe for application on the areas of skin where epidurals (lower back) and arterial lines (wrist) are placed, based on whether they introduce microbial growth to these areas. The investigators will compare microbial growth by swabbing both of these skin sites following: 1) no treatment 2) ChloraPrep treatment and 3) ChloraPrep plus numbing spray (Ethyl Chloride or Pain Ease) treatment. The cultures will then be incubated to test for anaerobic bacteria, aerobic bacteria, and mold growth. The microbial growth will be compared between the three treatment groups based on the number of colony forming units present. Funding for the project will be from the manufacturer of the numbing sprays, Gebauer Company. Based on power analysis, for each of the numbing sprays, a total of 72 subjects must be enrolled, with 6 swabs taken per subject (untreated, ChloraPrep, and topical anesthetic spray samples will be taken from both the wrist and lower back of each subject). A sample size of 72 pairs achieves 80 % power to detect an odds ratio of 24 using a two-sided McNemar test with a significance level of 0.05.
Interventions
DRUGGebauer's Pain Ease Top Aerosol Mist Spray
Topical refrigerant spray
Topical refrigerant spray
Sponsors
Gebauer Company
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Microbial Growth (1+ CFU) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Microbial Growth on Skin After Application of Gebauer's Ethyl Chloride or Pain Ease In a split-person design, each subject had four areas of skin swabbed as follows:
* Left wrist swabbed before and after Chloraprep application, and again after application of Gebauer's Ethyl Chloride topical refrigerant spray
* Right wrist swabbed before and after Chloraprep application, and again after application of Gebauer's Pain Ease.
* Low back swabbed before and after Chloraprep application, and then after application of Gebauer's Ethyl Chloride topical refrigerant spray.
* Another section of low back swabbed before and after Chloraprep application, and then after application of Gebauer's Pain Ease topical refrigerant spray.
The bacterial growth prior to and after numbing spray application were evaluated based on the number of colony forming units that were present. | 72 |
| Total | 72 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | — years |
| Race and Ethnicity Not Collected | — Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 72 | 0 / 72 | 0 / 72 |
| other Total, other adverse events | 0 / 72 | 0 / 72 | 0 / 72 | 0 / 72 |
| serious Total, serious adverse events | 0 / 72 | 0 / 72 | 0 / 72 | 0 / 72 |
Outcome results
Primary
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Wrist, Gebauer's Ethyl Chloride | Presence of Microbial Growth (1+ CFU) | Samples with positive growth after application of ChloraPrep followed by topical refrigerant spray | 2 Number of samples with 1+ CFU |
| Wrist, Gebauer's Ethyl Chloride | Presence of Microbial Growth (1+ CFU) | Samples with positive growth before ChloraPrep treatment (positive control) | 68 Number of samples with 1+ CFU |
| Wrist, Gebauer's Ethyl Chloride | Presence of Microbial Growth (1+ CFU) | Samples with positive growth after application of ChloraPrep | 1 Number of samples with 1+ CFU |
| Lower Back, Gebauer's Ethyl Chloride | Presence of Microbial Growth (1+ CFU) | Samples with positive growth after application of ChloraPrep followed by topical refrigerant spray | 1 Number of samples with 1+ CFU |
| Lower Back, Gebauer's Ethyl Chloride | Presence of Microbial Growth (1+ CFU) | Samples with positive growth before ChloraPrep treatment (positive control) | 63 Number of samples with 1+ CFU |
| Lower Back, Gebauer's Ethyl Chloride | Presence of Microbial Growth (1+ CFU) | Samples with positive growth after application of ChloraPrep | 0 Number of samples with 1+ CFU |
| Wrist, Gebauer's Pain Ease | Presence of Microbial Growth (1+ CFU) | Samples with positive growth after application of ChloraPrep | 0 Number of samples with 1+ CFU |
| Wrist, Gebauer's Pain Ease | Presence of Microbial Growth (1+ CFU) | Samples with positive growth after application of ChloraPrep followed by topical refrigerant spray | 1 Number of samples with 1+ CFU |
| Wrist, Gebauer's Pain Ease | Presence of Microbial Growth (1+ CFU) | Samples with positive growth before ChloraPrep treatment (positive control) | 65 Number of samples with 1+ CFU |
| Lower Back, Gebauer's Pain Ease | Presence of Microbial Growth (1+ CFU) | Samples with positive growth after application of ChloraPrep followed by topical refrigerant spray | 1 Number of samples with 1+ CFU |
| Lower Back, Gebauer's Pain Ease | Presence of Microbial Growth (1+ CFU) | Samples with positive growth before ChloraPrep treatment (positive control) | 49 Number of samples with 1+ CFU |
| Lower Back, Gebauer's Pain Ease | Presence of Microbial Growth (1+ CFU) | Samples with positive growth after application of ChloraPrep | 2 Number of samples with 1+ CFU |
Comparison: Comparison of incidence of positive growth in samples obtained following application of ChloraPrep vs. ChloraPrep followed by Gebauer's Ethyl Chloride.p-value: 0.317Friedman
Comparison: Comparison of incidence of positive growth in samples obtained following application of ChloraPrep vs. ChloraPrep followed by Gebauer's Ethyl Chloride.p-value: 0.317Friedman
Comparison: Comparison of incidence of positive growth in samples obtained following application of ChloraPrep vs. ChloraPrep followed by Gebauer's Pain Ease.p-value: 0.317Friedman
Comparison: Comparison of incidence of positive growth in samples obtained following application of ChloraPrep vs. ChloraPrep followed by Gebauer's Pain Ease.p-value: 0.317Friedman