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Is Pain Ease (New Formula) Safe and Effective in Reducing Pain Associated With Peripheral Intravenous Cannulation (PIV)?
Sponsor: Gebauer Company
Summary
The goal of this clinical trial is to learn if Pain Ease (new formula) is more effective than Nature's Tears in reducing pain associated with Peripheral Intravenous Cannulation (PIV), also known as an IV. This clinical trial will also learn if Pain Ease (new formula) increases the germs at the application site. The main questions it aims to answer are: 1. Will Pain Ease (new formula) reduce the amount of pain when receiving an IV? 2. Will the microbes increase when Pain Ease (new formula) is applied on cleansed skin? Participants will: 1. Either have Pain Ease (new formula) or Nature's Tears sprayed on the skin prior to receiving an IV 2. Complete questionnaires on how the experience was 3. Complete the study within 60 minutes after the application of either spray, if no reactions occur
Official title: Prospective, Randomized, Double-Blinded, Comparative Efficacy Safety and Microbial Limits Clinical Trial of Gebauer's Pain Ease (New Formula) Instant Topical Anesthetic Spray for Peripheral Intravenous Cannulation
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-12
Completion Date
2027-01
Last Updated
2026-09-15
Healthy Volunteers
Yes
Interventions
Sterile water
The sterile water is preservative and chemical free, and non-allergenic. The sterile water can is contained in an aerosol packaging consisting of an aluminum can which size and nozzle are comparable to Pain Ease (new formula) package.
Vapocoolant spray
The vapocoolant spray is a blend of high purity hydrofluoroolefins (HFO)-1233zd (1-Chloro-3,3,3-trifluoroprop-1-ene) and high purity HFO-1234ze (1,3,3,3-Tetrafluoroprop-1-ene). The vapocoolant is contained in an aerosol packaging consisting of a lined aluminum can, coated aluminum-cup valve with an elastomer stem gasket, plastic dip tube, and a plastic actuator.
Locations (1)
Indiana University School of Medicine, Dept of Emergency Medicine
Indianapolis, Indiana, United States