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
The primary objective of the study is to demonstrate the superiority of Pain Ease (new formula) versus placebo (Nature's Tears) in reducing pain associated with PIV cannulation. Additionally, the study aims to evaluate the microbial limits of Pain Ease (new formula) by evaluating the number of viable microbes detected on the PIV site when applying Pain Ease (new formula) after Chlorhexidine Gluconate (CHG) cleaning compared to CHG cleaning only. The secondary objective of the study is to evaluate the success rate of PIV cannulation and satisfaction of treated subjects and healthcare providers with Pain Ease (new formula) or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
100
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.
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.
Indiana University School of Medicine, Dept of Emergency Medicine
Indianapolis, Indiana, United States
Demonstrate the superiority of Pain Ease (new formula) versus placebo (Nature's Tears) in reducing pain associated with PIV cannulation.
To be determined by the numeric rating scale.
Time frame: From enrollment to the end of the observational period (up to 60 minutes)
Evaluate the microbial limits of Pain Ease (new formula) by evaluating the number of viable microbes detected on the PIV site when applying Pain Ease (new formula) after Chlorhexidine Gluconate (CHG) cleaning compared to CHG cleaning only.
To be determined by microbial testing in the Microbiology lab.
Time frame: From enrollment to the end of the observational period (up to 60 minutes)
Evaluate the success rate of PIV cannulation and satisfaction of treated subjects and healthcare providers with Pain Ease (new formula) or placebo.
To be determined by Patient Reported Outcomes and Healthcare Provided Questionnaires.
Time frame: From enrollment to the end of the observational period (up to 60 minutes)
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