Is Pain Ease (New Formula) Safe and Effective in Reducing Pain Associated With Peripheral Intravenous Cannulation (PIV)?
10. september 2026 oppdatert av: Gebauer Company
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?
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
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
100
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Andrew Ditto
- Telefonnummer: 167 216-581-3030
- E-post: andrew.ditto@gebauer.com
Studer Kontakt Backup
- Navn: Kathleen Orellana
- Telefonnummer: 440-623-1662
- E-post: kathleen.orellana@gebauer.com
Studiesteder
-
-
Indiana
-
Indianapolis, Indiana, Forente stater, 46202
- Indiana University School of Medicine, Dept of Emergency Medicine
-
Hovedetterforsker:
- Paul Musey
-
Ta kontakt med:
- Dr. Paul Musey
- Telefonnummer: 317-880-3900
- E-post: pmusey@iu.edu
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Patients needing peripheral intravenous (PIV) cannulation.
- Adults aged 18 to 75 years.
- Mentally competent patients able to understand the consent.
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).
- 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).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
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.
|
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Placebo komparator: 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.
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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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Demonstrate the superiority of Pain Ease (new formula) versus placebo (Nature's Tears) in reducing pain associated with PIV cannulation.
Tidsramme: From enrollment to the end of the observational period (up to 60 minutes)
|
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.
Tidsramme: From enrollment to the end of the observational period (up to 60 minutes)
|
To be determined by microbial testing in the Microbiology lab.
|
From enrollment to the end of the observational period (up to 60 minutes)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Evaluate the success rate of PIV cannulation and satisfaction of treated subjects and healthcare providers with Pain Ease (new formula) or placebo.
Tidsramme: From enrollment to the end of the observational period (up to 60 minutes)
|
To be determined by Patient Reported Outcomes and Healthcare Provided Questionnaires.
|
From enrollment to the end of the observational period (up to 60 minutes)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. desember 2026
Primær fullføring (Antatt)
1. januar 2027
Studiet fullført (Antatt)
1. januar 2027
Datoer for studieregistrering
Først innsendt
10. september 2026
Først innsendt som oppfylte QC-kriteriene
10. september 2026
Først lagt ut (Faktiske)
15. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Pain Ease (new formula)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
produkt produsert i og eksportert fra USA
Nei
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