[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100472875":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":194,"collaborators":198,"id":202,"slug":25,"hasResults":203,"nctId":204,"briefTitle":205,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":203,"sex":208,"minAge":209,"maxAge":25,"enrollmentInfo":210,"targetDuration":25,"studyType":213,"phases":214,"briefSummary":216,"conditions":217,"keywords":219,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":234},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ketamine Hydrochloride","EXPERIMENTAL","2 blinded doses 2.5mg\u002Fml ketamine hydrochloride in separately sealed pre-filled syringes Subjects will be administered the first dose over approximately 2 minutes via slow IV push. Pain assessment following administration will be obtained and recorded every 15 minutes. Redosing may occur after approximately 15 minutes if the subject has a qualifying pain score, there are no contraindications to pain medication per local protocol, and no exclusion criteria have been met.",[13],"Drug: Ketamine Hydrochloride",{"label":15,"type":16,"description":17,"interventionNames":18},"Fentanyl Citrate","ACTIVE_COMPARATOR","2 blinded doses 10mcg\u002Fml in separately sealed pre-filled syringes Subjects will be administered the first dose over approximately 2 minutes via slow IV push. Pain assessment following administration will be obtained and recorded every 15 minutes. Redosing may occur after approximately 15 minutes if the subject has a qualifying pain score, there are no contraindications to pain medication per local protocol, and no exclusion criteria have been met.",[19],"Drug: Fentanyl Citrate",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","ketamine hydrochloride 2.5mg\u002Fml packaged in pre-filled syringe",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"fentanyl citrate 10mcg\u002Fml packaged in pre-filled syringe",[15],[30],{"name":31,"affiliation":5,"role":32},"Jason Sperry, MD","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},"CONTACT","412-802-8270","sperryjl@upmc.edu",[39,57,71,86,101,116,131,140,154,168,183],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"University of California, San Diego","RECRUITING","San Diego","California","92103","United States",{"type":47,"coordinates":48},"Point",[49,50],-117.16472,32.71571,{"lat":50,"lon":49},[53],{"name":54,"role":35,"phone":55,"phoneExt":25,"email":56},"Laura Haines, MD","619-543-7200","lhaines@health.ucsd.edu",{"facility":58,"status":41,"city":59,"state":43,"zip":60,"country":45,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Zuckerberg San Francisco General Hospital","San Francisco","94110",{"type":47,"coordinates":62},[63,64],-122.41942,37.77493,{"lat":64,"lon":63},[67],{"name":68,"role":35,"phone":69,"phoneExt":25,"email":70},"Lucy Kornblith, MD","415-609-6924","Lucy.Kornblith@ucsf.edu",{"facility":72,"status":41,"city":73,"state":74,"zip":75,"country":45,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Cooper University Health Care","Camden","New Jersey","08103",{"type":47,"coordinates":77},[78,79],-75.11962,39.92595,{"lat":79,"lon":78},[82],{"name":83,"role":35,"phone":84,"phoneExt":25,"email":85},"Tanya Egodage","856-342-3341","egodage-tanya@cooperhealth.edu",{"facility":87,"status":41,"city":88,"state":89,"zip":90,"country":45,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Atrium Health and Carolinas Medical Center","Charlotte","North Carolina","28203",{"type":47,"coordinates":92},[93,94],-80.84313,35.22709,{"lat":94,"lon":93},[97],{"name":98,"role":35,"phone":99,"phoneExt":25,"email":100},"Addison May, MD","704 446-2504","addison.may@atriumhealth.org",{"facility":102,"status":41,"city":103,"state":104,"zip":105,"country":45,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"University of Cincinnati","Cincinnati","Ohio","45267",{"type":47,"coordinates":107},[108,109],-84.51439,39.12711,{"lat":109,"lon":108},[112],{"name":113,"role":35,"phone":114,"phoneExt":25,"email":115},"Jason McMullan, MD","513-675-3072","Jason.McMullan@uc.edu",{"facility":117,"status":41,"city":118,"state":119,"zip":120,"country":45,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Allegheny Health Network (AHN) Allegheny General Hospital","Pittsburgh","Pennsylvania","15212",{"type":47,"coordinates":122},[123,124],-79.99589,40.44062,{"lat":124,"lon":123},[127],{"name":128,"role":35,"phone":129,"phoneExt":25,"email":130},"Philip Nawrocki, MD","4124876590","philip.nawrocki@ahn.org",{"facility":5,"status":41,"city":118,"state":119,"zip":132,"country":45,"cosmosGeoPoint":133,"geoPoint":135,"contacts":136},"15213",{"type":47,"coordinates":134},[123,124],{"lat":124,"lon":123},[137,139],{"name":31,"role":35,"phone":138,"phoneExt":25,"email":37},"412-647-3065",{"name":31,"role":32,"phone":25,"phoneExt":25,"email":25},{"facility":141,"status":41,"city":142,"state":119,"zip":143,"country":45,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Guthrie Robert Packer Hospital","Sayre","18840",{"type":47,"coordinates":145},[146,147],-76.5155,41.97896,{"lat":147,"lon":146},[150],{"name":151,"role":35,"phone":152,"phoneExt":25,"email":153},"Jon Rittenberger, MD","570-887-4318","Jon.Rittenberger@guthrie.org",{"facility":155,"status":41,"city":156,"state":157,"zip":158,"country":45,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"University of Utah","Salt Lake City","Utah","84132",{"type":47,"coordinates":160},[161,162],-111.89105,40.76078,{"lat":162,"lon":161},[165],{"name":166,"role":35,"phone":25,"phoneExt":25,"email":167},"Scott Youngquist, MD","scott.youngquist@hsc.utah.edu",{"facility":169,"status":41,"city":170,"state":171,"zip":172,"country":45,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"The University of Vermont Larner College of Medicine","Burlington","Vermont","05405",{"type":47,"coordinates":174},[175,176],-73.21207,44.47588,{"lat":176,"lon":175},[179],{"name":180,"role":35,"phone":181,"phoneExt":25,"email":182},"Daniel Wolfson, MD, FACEP, FAEMS","802-847-2434","daniel.wolfson@uvmhealth.org",{"facility":184,"status":185,"city":186,"state":187,"zip":188,"country":45,"cosmosGeoPoint":189,"geoPoint":193,"contacts":25},"Medical College of Wisconsin","SUSPENDED","Milwaukee","Wisconsin","53266",{"type":47,"coordinates":190},[191,192],-87.90647,43.0389,{"lat":192,"lon":191},{"type":195,"investigatorFullName":196,"investigatorTitle":197,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Jason Sperry","Professor",[199],{"name":200,"class":201},"United States Department of Defense","FED","100472875",false,"NCT05437575","Prehospital Analgesia INtervention Trial (PAIN)","PAIN","Inclusion Criteria:\n\n* Transport after injury to a participating PAIN Trauma center\n* 2\\. Patient with compensated shock as defined by Shock Index (SI) ≥0.9 or Heart Rate (HR) ≥115.\n* Intravenous pain medication indicated (CPOT≥2, NRS≥5) prior to arrival at the trauma center\n\nExclusion Criteria:\n\n* No IV access\n* Age \\\u003C18 years\n* Females \\\u003C50 years of age\n* SBP\\>180 mmHg at time of enrollment\n* Advanced airway management prior to first dose administration\n* Known allergy to fentanyl citrate or ketamine hydrochloride\n* Known prisoner\n* Objection to study voiced by subject or family member at scene\n* Pain treatment contraindicated by local protocol\n* Wearing a \"NO PAIN STUDY\" bracelet","ALL","18 Years",{"count":211,"type":212},994,"ESTIMATED","INTERVENTIONAL",[215],"PHASE3","The Prehospital Analgesia INtervention trial (PAIN) is a proposed 4 year (3-year enrollment) multicenter, prehospital, randomized, double-blind, clinical trial that will enroll approximately 994 patients at select LITES Network sites. The objective is to perform a prospective, interventional, randomized trial among prehospital trauma patients with compensated shock (SI≥0.9 or HR ≥115) and an indication for pain management, comparing patient centered outcomes following prehospital administration of ketamine hydrochloride versus fentanyl citrate.",[218],"Traumatic Injury",[220,221,222,223,224],"Trauma","ketamine hydrochloride","fentanyl citrate","shock","pain","2026-03-05",{"date":227,"type":228},"2026-03-09","ACTUAL",{"date":230,"type":228},"2023-11-27",{"date":232,"type":212},"2029-07",{"name":196,"class":6},11]