Peripheral Intravenous CannulationNCT07821476
Is Pain Ease (New Formula) Safe and Effective in Reducing Pain Associated With Peripheral Intravenous Cannulation (PIV)?
A study testing Sterile water and Vapocoolant spray in people with Peripheral Intravenous Cannulation and Pain Management, run by Gebauer Company at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Intravenous Cannulation, Pain Management
- What is being tested?
- Sterile water and Vapocoolant spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients needing peripheral intravenous (PIV) cannulation.
- Adults aged 18 to 75 years.
- Mentally competent patients able to understand the consent.
Who cannot join
- 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.
Show all 9Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Indiana University School of Medicine, Dept of Emergency Medicine
Indianapolis, Indiana, 46202
Dr. Paul Musey, 317-880-3900, pmusey@iu.edu
Paul Musey
About this study
Official title: Prospective, Randomized, Double-Blinded, Comparative Efficacy Safety and Microbial Limits Clinical Trial of Gebauer's Pain Ease (New Formula) Instant Topical Anesthetic Spray for Peripheral Intravenous Cannulation
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:
- Will Pain Ease (new formula) reduce the amount of pain when receiving an IV?
- Will the microbes increase when Pain Ease (new formula) is applied on cleansed skin?
Read more
Participants will:
- Either have Pain Ease (new formula) or Nature's Tears sprayed on the skin prior to receiving an IV
- Complete questionnaires on how the experience was
- Complete the study within 60 minutes after the application of either spray, if no reactions occur
Read the 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.
- Being tested
- Sterile water, Vapocoolant spray
- Keywords
- IV, Intravenous Cannulation, Peripheral Intravenous Cannulation, Pain Management, Topical Anesthetic Spray, Vapocoolant, MLY, Cold spray, Patient satisfaction, PIV, Pain Spray
- Medical subject headings
- Agnosia, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sterile waterOther
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 sprayDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sterile water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
To be determined by Patient Reported Outcomes and Healthcare Provided Questionnaires.
Measured: From enrollment to the end of the observational period (up to 60 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study startDec 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Intravenous CannulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gebauer Company
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821476
- Sponsor's protocol ID
- Pain Ease (new formula)
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double-Blinded, Comparative Efficacy Safety and Microbial Limits Clinical Trial of Gebauer's Pain Ease (New Formula) Instant Topical Anesthetic Spray for Peripheral Intravenous Cannulation
- ClinicalTrials.gov ID
- NCT07821476
- Acronym / sponsor ID
- Pain Ease (new formula)
- Keywords
- IV, Intravenous Cannulation, Peripheral Intravenous Cannulation, Pain Management, Topical Anesthetic Spray, Vapocoolant, MLY, Cold spray
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Gebauer CompanyResearch network
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Will Pain Ease (new formula) reduce the amount of pain when receiving an IV?
- Will the microbes increase when Pain Ease (new formula) is applied on cleansed skin?
Participants will:
- Either have Pain Ease (new formula) or Nature's Tears sprayed on the skin prior to receiving an IV
- Complete questionnaires on how the experience was
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| To study safety and efficacy | Active comparator | Device: Vapocoolant sprayPain 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. |
| To study microbial limits | Placebo comparator | Other: Sterile waterNature'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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients needing peripheral intravenous (PIV) cannulation.
- Adults aged 18 to 75 years.
- Mentally competent patients able to understand the consent.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sterile waterThe 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. | Other | To study microbial limits |
| Vapocoolant sprayThe 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. | Device | To study safety and efficacy |
Primary outcome
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)
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.
Time frame: From enrollment to the end of the observational period (up to 60 minutes)
To be determined by microbial testing in the Microbiology lab.
1 secondary outcome
Evaluate the success rate of PIV cannulation and satisfaction of treated subjects and healthcare providers with Pain Ease (new formula) or placebo.
Time frame: From enrollment to the end of the observational period (up to 60 minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sterile water and Vapocoolant spray in people with Peripheral Intravenous Cannulation and Pain Management, run by Gebauer Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew Ditto (216-581-3030 ext. 167, andrew.ditto@gebauer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026; AzTrials last refreshed its copy on 30 Oct 2026.