Is Pain Ease (New Formula) Safe and Effective in Reducing Pain Associated With Peripheral Intravenous Cannulation (PIV)?
10 september 2026 uppdaterad 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
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
100
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Andrew Ditto
- Telefonnummer: 167 216-581-3030
- E-post: andrew.ditto@gebauer.com
Studera Kontakt Backup
- Namn: Kathleen Orellana
- Telefonnummer: 440-623-1662
- E-post: kathleen.orellana@gebauer.com
Studieorter
-
-
Indiana
-
Indianapolis, Indiana, Förenta staterna, 46202
- Indiana University School of Medicine, Dept of Emergency Medicine
-
Huvudutredare:
- Paul Musey
-
Kontakt:
- Dr. Paul Musey
- Telefonnummer: 317-880-3900
- E-post: pmusey@iu.edu
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / 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.
|
|
Placebo-jämförare: 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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Demonstrate the superiority of Pain Ease (new formula) versus placebo (Nature's Tears) in reducing pain associated with PIV cannulation.
Tidsram: 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.
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Evaluate the success rate of PIV cannulation and satisfaction of treated subjects and healthcare providers with Pain Ease (new formula) or placebo.
Tidsram: 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)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 december 2026
Primärt slutförande (Beräknad)
1 januari 2027
Avslutad studie (Beräknad)
1 januari 2027
Studieregistreringsdatum
Först inskickad
10 september 2026
Först inskickad som uppfyllde QC-kriterierna
10 september 2026
Första postat (Faktisk)
15 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
15 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Pain Ease (new formula)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
produkt tillverkad i och exporterad från U.S.A.
Nej
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