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

NCT07821476 | Not Yet Recruiting FDA Device

• 1 other identifier: Pain Ease (new formula)
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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. 1.Will Pain Ease (new formula) reduce the amount of pain when receiving an IV?
2. 2.Will the microbes increase when Pain Ease (new formula) is applied on cleansed skin?
3. 3.Either have Pain Ease (new formula) or Nature's Tears sprayed on the skin prior to receiving an IV
4. 4.Complete questionnaires on how the experience was
5. 5.Complete the study within 60 minutes after the application of either spray, if no reactions occur

Conditions

Pain Management; Peripheral Intravenous Cannulation

Keywords

IV; Intravenous Cannulation; Peripheral Intravenous Cannulation; Pain Management; Topical Anesthetic Spray; Vapocoolant; MLY; Cold spray; Patient satisfaction; PIV; Pain Spray

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From enrollment to the end of the observational period (up to 60 minutes)

Secondary Outcomes (1)

• 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)

Study Arms (2)

To study safety and efficacy

ACTIVE COMPARATOR

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.

Device: Vapocoolant spray

To study microbial limits

PLACEBO COMPARATOR

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.

Other: Sterile water

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.

To study microbial limits

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.

To study safety and efficacy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients needing peripheral intravenous (PIV) cannulation.
• Adults aged 18 to 75 years.
• Mentally competent patients able to understand the consent.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Gebauer Company: lead

Study Sites (1)

Indiana University School of Medicine, Dept of Emergency Medicine

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Agnosia; Patient Satisfaction

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Andrew Ditto

CONTACT

216-581-3030; andrew.ditto@gebauer.com

Kathleen Orellana

CONTACT

440-623-1662; kathleen.orellana@gebauer.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Microbiology lab
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 15, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 15, 2026

Record last verified: 2026-09

Locations

US (1)