[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100472875":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":195,"collaborators":199,"id":203,"slug":204,"hasResults":205,"nctId":206,"briefTitle":207,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":205,"sex":210,"minAge":211,"maxAge":25,"enrollmentInfo":212,"targetDuration":25,"studyType":215,"phases":216,"briefSummary":218,"conditions":219,"keywords":221,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":236},{"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",[39,58,72,87,102,117,132,141,155,169,184],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"University of California, San Diego","RECRUITING","San Diego","California","92103","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-117.16472,32.71571,{"lat":51,"lon":50},[54],{"name":55,"role":35,"phone":56,"phoneExt":25,"email":57},"Laura Haines, MD","619-543-7200","lhaines@health.ucsd.edu",{"facility":59,"status":41,"city":60,"state":43,"zip":61,"country":45,"countryCode":46,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Zuckerberg San Francisco General Hospital","San Francisco","94110",{"type":48,"coordinates":63},[64,65],-122.41942,37.77493,{"lat":65,"lon":64},[68],{"name":69,"role":35,"phone":70,"phoneExt":25,"email":71},"Lucy Kornblith, MD","415-609-6924","Lucy.Kornblith@ucsf.edu",{"facility":73,"status":41,"city":74,"state":75,"zip":76,"country":45,"countryCode":46,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Cooper University Health Care","Camden","New Jersey","08103",{"type":48,"coordinates":78},[79,80],-75.11962,39.92595,{"lat":80,"lon":79},[83],{"name":84,"role":35,"phone":85,"phoneExt":25,"email":86},"Tanya Egodage","856-342-3341","egodage-tanya@cooperhealth.edu",{"facility":88,"status":41,"city":89,"state":90,"zip":91,"country":45,"countryCode":46,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Atrium Health and Carolinas Medical Center","Charlotte","North Carolina","28203",{"type":48,"coordinates":93},[94,95],-80.84313,35.22709,{"lat":95,"lon":94},[98],{"name":99,"role":35,"phone":100,"phoneExt":25,"email":101},"Addison May, MD","704 446-2504","addison.may@atriumhealth.org",{"facility":103,"status":41,"city":104,"state":105,"zip":106,"country":45,"countryCode":46,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"University of Cincinnati","Cincinnati","Ohio","45267",{"type":48,"coordinates":108},[109,110],-84.51439,39.12711,{"lat":110,"lon":109},[113],{"name":114,"role":35,"phone":115,"phoneExt":25,"email":116},"Jason McMullan, MD","513-675-3072","Jason.McMullan@uc.edu",{"facility":118,"status":41,"city":119,"state":120,"zip":121,"country":45,"countryCode":46,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Allegheny Health Network (AHN) Allegheny General Hospital","Pittsburgh","Pennsylvania","15212",{"type":48,"coordinates":123},[124,125],-79.99589,40.44062,{"lat":125,"lon":124},[128],{"name":129,"role":35,"phone":130,"phoneExt":25,"email":131},"Philip Nawrocki, MD","4124876590","philip.nawrocki@ahn.org",{"facility":5,"status":41,"city":119,"state":120,"zip":133,"country":45,"countryCode":46,"cosmosGeoPoint":134,"geoPoint":136,"contacts":137},"15213",{"type":48,"coordinates":135},[124,125],{"lat":125,"lon":124},[138,140],{"name":31,"role":35,"phone":139,"phoneExt":25,"email":37},"412-647-3065",{"name":31,"role":32,"phone":25,"phoneExt":25,"email":25},{"facility":142,"status":41,"city":143,"state":120,"zip":144,"country":45,"countryCode":46,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Guthrie Robert Packer Hospital","Sayre","18840",{"type":48,"coordinates":146},[147,148],-76.5155,41.97896,{"lat":148,"lon":147},[151],{"name":152,"role":35,"phone":153,"phoneExt":25,"email":154},"Jon Rittenberger, MD","570-887-4318","Jon.Rittenberger@guthrie.org",{"facility":156,"status":41,"city":157,"state":158,"zip":159,"country":45,"countryCode":46,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"University of Utah","Salt Lake City","Utah","84132",{"type":48,"coordinates":161},[162,163],-111.89105,40.76078,{"lat":163,"lon":162},[166],{"name":167,"role":35,"phone":25,"phoneExt":25,"email":168},"Scott Youngquist, MD","scott.youngquist@hsc.utah.edu",{"facility":170,"status":41,"city":171,"state":172,"zip":173,"country":45,"countryCode":46,"cosmosGeoPoint":174,"geoPoint":178,"contacts":179},"The University of Vermont Larner College of Medicine","Burlington","Vermont","05405",{"type":48,"coordinates":175},[176,177],-73.21207,44.47588,{"lat":177,"lon":176},[180],{"name":181,"role":35,"phone":182,"phoneExt":25,"email":183},"Daniel Wolfson, MD, FACEP, FAEMS","802-847-2434","daniel.wolfson@uvmhealth.org",{"facility":185,"status":186,"city":187,"state":188,"zip":189,"country":45,"countryCode":46,"cosmosGeoPoint":190,"geoPoint":194,"contacts":25},"Medical College of Wisconsin","SUSPENDED","Milwaukee","Wisconsin","53266",{"type":48,"coordinates":191},[192,193],-87.90647,43.0389,{"lat":193,"lon":192},{"type":196,"investigatorFullName":197,"investigatorTitle":198,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Jason Sperry","Professor",[200],{"name":201,"class":202},"United States Department of Defense","FED","100472875","phase-3-prehospital-analgesia-intervention-trial-pain-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":213,"type":214},994,"ESTIMATED","INTERVENTIONAL",[217],"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.",[220],"Traumatic Injury",[222,223,224,225,226],"Trauma","ketamine hydrochloride","fentanyl citrate","shock","pain","2026-03-05",{"date":229,"type":230},"2026-03-09","ACTUAL",{"date":232,"type":230},"2023-11-27",{"date":234,"type":214},"2029-07",{"name":197,"class":6},11]