[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656070":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":32,"studyPopulation":20,"armGroups":33,"interventions":46,"overallOfficials":20,"centralContacts":57,"locations":68,"responsibleParty":90,"collaborators":20,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":20,"eligibilityCriteria":98,"healthyVolunteers":99,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":20,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":123,"whyStopped":20,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Gebauer Company","NETWORK",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":20},[9,13],{"measure":10,"description":11,"timeFrame":12},"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)",{"measure":14,"description":15,"timeFrame":12},"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.",[17],{"measure":18,"description":19,"timeFrame":12},"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.",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":20,"primaryPurpose":24,"observationalModel":20,"timePerspective":20,"maskingInfo":25},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":26,"maskingDescription":27,"whoMasked":28},"TRIPLE","Microbiology lab",[29,30,31],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","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.",[34,40],{"label":35,"type":36,"description":37,"interventionNames":38},"To study safety and efficacy","ACTIVE_COMPARATOR","Pain Ease (new formula, P\u002FN 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.",[39],"Device: Vapocoolant spray",{"label":41,"type":42,"description":43,"interventionNames":44},"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.",[45],"Other: Sterile water",[47,52],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":20},"OTHER","Sterile water","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.",[41],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":20},"DEVICE","Vapocoolant spray","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.",[35],[58,64],{"name":59,"role":60,"phone":61,"phoneExt":62,"email":63},"Andrew Ditto","CONTACT","216-581-3030","167","andrew.ditto@gebauer.com",{"name":65,"role":60,"phone":66,"phoneExt":20,"email":67},"Kathleen Orellana","440-623-1662","kathleen.orellana@gebauer.com",[69],{"facility":70,"status":20,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Indiana University School of Medicine, Dept of Emergency Medicine","Indianapolis","Indiana","46202","United States","US",{"type":77,"coordinates":78},"Point",[79,80],-86.15804,39.76838,{"lat":80,"lon":79},[83,87],{"name":84,"role":60,"phone":85,"phoneExt":20,"email":86},"Dr. Paul Musey","317-880-3900","pmusey@iu.edu",{"name":88,"role":89,"phone":20,"phoneExt":20,"email":20},"Paul Musey","PRINCIPAL_INVESTIGATOR",{"type":91,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100656070","is-pain-ease-new-formula-safe-and-effective-in-reducing-pain-associated-with-peripheral-intravenous-cannulation-piv-100656070",false,"NCT07821476","Is Pain Ease (New Formula) Safe and Effective in Reducing Pain Associated With Peripheral Intravenous Cannulation (PIV)?","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","Inclusion Criteria:\n\n* Patients needing peripheral intravenous (PIV) cannulation.\n* Adults aged 18 to 75 years.\n* Mentally competent patients able to understand the consent.\n\nExclusion Criteria:\n\n* Patients with any allergies to the spray components (e.g., 1-chloro-3,3,3-trifluoro-1-propene or 1,3,3,3-Tetrafluoropropene).\n* Critically ill or unstable (e.g., sepsis or shock).\n* Infants and children of age \\\u003C18 years, and adults over the age of 75.\n* Pregnant.\n* Peripheral intravenous cannulation site located in area of poor circulation. Examples include: patients with peripheral vascular disease, gangrene, Buerger's disease.\n* Peripheral intravenous cannulation site located in area of insensitive skin; such as, patients with a peripheral neuropathy including diabetic neuropathy.\n* Patient intolerant of cold or with hypersensitivity to the cold. Examples include: Raynaud's disease and sickle-cell anemia.\n* Patient unable or unwilling to give consent.\n* Patients exhibiting signs of skin irritation at the procedure site (e.g.: urticaria).",true,"ALL","18 Years","75 Years",{"count":104,"type":105},100,"ESTIMATED","INTERVENTIONAL",[108],"NA","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:\n\n1. Will Pain Ease (new formula) reduce the amount of pain when receiving an IV?\n2. Will the microbes increase when Pain Ease (new formula) is applied on cleansed skin?\n\nParticipants will:\n\n1. Either have Pain Ease (new formula) or Nature's Tears sprayed on the skin prior to receiving an IV\n2. Complete questionnaires on how the experience was\n3. Complete the study within 60 minutes after the application of either spray, if no reactions occur",[111,112],"Peripheral Intravenous Cannulation","Pain Management",[114,115,111,112,116,117,118,119,120,121,122],"IV","Intravenous Cannulation","Topical Anesthetic Spray","Vapocoolant","MLY","Cold spray","Patient satisfaction","PIV","Pain Spray","NOT_YET_RECRUITING","2026-09-10",{"date":126,"type":127},"2026-09-15","ACTUAL",{"date":129,"type":105},"2026-12",{"date":131,"type":105},"2027-01",{"name":5,"class":6},1]