Is Pain Ease (New Formula) Safe and Effective in Reducing Pain Associated With Peripheral Intravenous Cannulation (PIV)?

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Gebauer Company
Study ID
NCT07821476
Status
Not Yet Recruiting

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Conditions

  • Pain Management
  • Peripheral Intravenous Cannulation

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Sterile water — OTHER
    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 — DEVICE
    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.

Study Details

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

Key Dates

First listed
Sep 15, 2026
Start date
Dec 31, 2026
Status verified
Sep 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: To study safety and efficacy
    Pain Ease (new formula, P/N 0386-0008-13) hereafter referred to as "Pain Ease (new formula)" 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). Pain Ease (new formula) 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.
  • Placebo Comparator: To study microbial limits
    Nature's Tears Eye Mist® 3 oz can is sterile water, preservative and chemical free, and non-allergenic. Nature's Tears Eye Mist® 3 oz can is contained in an aerosol packaging consisting of an aluminum can which size and nozzle are comparable to Pain Ease (new formula) package.

Primary Outcome Measure

Demonstrate the superiority of Pain Ease (new formula) versus placebo (Nature's Tears) in reducing pain associated with PIV cannulation. [ Time Frame: From enrollment to the end of the observational period (up to 60 minutes) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University School of Medicine, Dept of Emergency MedicineIndianapolisIndiana46202
Dr. Paul Musey
[email protected]
317-880-3900
Paul Musey (PRINCIPAL_INVESTIGATOR)

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By research site
Indiana University School of Medicine, Dept of Emergency Medicine· Indianapolis, IN

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