Pain Management, Peripheral Intravenous Cannulation
Conditions
Keywords
IV, Intravenous Cannulation, Peripheral Intravenous Cannulation, Pain Management, Topical Anesthetic Spray, Vapocoolant, MLY, Cold spray, Patient satisfaction, PIV, Pain Spray
Brief 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
Detailed description
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.
Interventions
OTHERSterile 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.
DEVICEVapocoolant 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.
Sponsors
Gebauer Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Microbiology lab
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients needing peripheral intravenous (PIV) cannulation. * Adults aged 18 to 75 years. * Mentally competent patients able to understand the consent.
Exclusion criteria
* Patients with any allergies to the spray components (e.g., 1-chloro-3,3,3-trifluoro-1-propene or 1,3,3,3-Tetrafluoropropene). * Critically ill or unstable (e.g., sepsis or shock). * Infants and children of age \<18 years, and adults over the age of 75. * Pregnant. * Peripheral intravenous cannulation site located in area of poor circulation. Examples include: patients with peripheral vascular disease, gangrene, Buerger's disease. * Peripheral intravenous cannulation site located in area of insensitive skin; such as, patients with a peripheral neuropathy including diabetic neuropathy. * Patient intolerant of cold or with hypersensitivity to the cold. Examples include: Raynaud's disease and sickle-cell anemia. * Patient unable or unwilling to give consent. * Patients exhibiting signs of skin irritation at the procedure site (e.g.: urticaria).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demonstrate the superiority of Pain Ease (new formula) versus placebo (Nature's Tears) in reducing pain associated with PIV cannulation. | From enrollment to the end of the observational period (up to 60 minutes) | To be determined by the numeric rating scale. |
| 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. | From enrollment to the end of the observational period (up to 60 minutes) | To be determined by microbial testing in the Microbiology lab. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the success rate of PIV cannulation and satisfaction of treated subjects and healthcare providers with Pain Ease (new formula) or placebo. | From enrollment to the end of the observational period (up to 60 minutes) | To be determined by Patient Reported Outcomes and Healthcare Provided Questionnaires. |
Countries
United States
Contacts
CONTACTAndrew Ditto
CONTACTKathleen Orellana
Outcome results
None listed