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

ConditionsPeripheral Intravenous CannulationPain Management
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGebauer Company

About 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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients needing peripheral intravenous (PIV) cannulation.

Adults aged 18 to 75 years.

Mentally competent patients able to understand the consent.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sterile water

    Other intervention

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: To study safety and efficacyActive comparator 1 intervention
Group B: To study microbial limitsPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to the end of the observational period (up to 60 minutes)
2

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.

Time frame
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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gebauer Company

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: