Pain Ease Spray for IV-Related Pain Management

AD
KO
Overseen ByKathleen Orellana
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Gebauer Company

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

This trial is for people who need an IV placed and are able to answer questions about their experience. Those with allergies or skin reactions to the sprays, open wounds at the site, or other conditions that could interfere may not be eligible.

Inclusion Criteria

Patients needing peripheral intravenous (PIV) cannulation
I am mentally able to understand and agree to the study.
I am between 18 and 75 years old.

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)
My IV site is in an area with poor blood flow or circulation problems.
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What Are the Treatments Tested in This Trial?

Interventions

  • Pain Ease (new formula)

Trial Overview

The study compares two sprays—Pain Ease (new formula) and Nature's Tears—to see which better reduces pain when getting an IV. Participants are randomly assigned one spray before IV placement and complete surveys afterward.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: To study safety and efficacyActive Control1 Intervention
Group II: To study microbial limitsPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Gebauer Company

Lead Sponsor

Trials
4
Recruited
490+