[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100467503":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":20,"centralContacts":24,"locations":32,"responsibleParty":115,"collaborators":119,"id":123,"slug":19,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":124,"sex":129,"minAge":130,"maxAge":131,"enrollmentInfo":132,"targetDuration":19,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":142,"overallStatus":35,"whyStopped":19,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Children undergoing Spine Fusion Surgery","This arm will include approximately 300 children undergoing spine fusion surgery\n\n1. Pharmacokinetic (PK): collection of 10-13 serial blood samples to determine serum levels of methadone\u002Foxycodone and its metabolites\n2. Pharmacogenetic (PG): Preoperative CYP2D6 genotyping (for preferential recruitment of CYP2D6 PMs and UMs). This will be collected in the pre-operative clinic via blood if there are clinical labs needed for standard of care. If no blood is needed in the pre-op clinic, the investigators will collect this via saliva.\n\nPostoperative Analgesia Dose and PK Sampling Schedule:\n\nClinical care providers are blinded to CYP2D6\u002FCYP2B6 when prescribing oxycodone\u002Fmethadone; and genetic analysis of proposed targeted genes. Results of these samples will be used to determine personalized analgesia plan.",[12],"Diagnostic Test: Preoperative Genotyping",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DIAGNOSTIC_TEST","Preoperative Genotyping","Genotype based risk prediction and personalized pain management",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Senthilkumar Sadhasivam, MD, MPH","PRINCIPAL_INVESTIGATOR",[25,29],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},"CONTACT","4126472994","sadhasivams@upmc.edu",{"name":30,"role":26,"phone":19,"phoneExt":19,"email":31},"Dayana Alsamsam, BSPS, MSc","alsamsamd@upmc.edu",[33,52,72,87,102],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"University of California","RECRUITING","San Francisco","California","38456","United States",{"type":41,"coordinates":42},"Point",[43,44],-122.41942,37.77493,{"lat":44,"lon":43},[47,50],{"name":48,"role":26,"phone":19,"phoneExt":19,"email":49},"Ridhima Jain","Ridhma.jain@ucsf.edu",{"name":51,"role":23,"phone":19,"phoneExt":19,"email":19},"Anshuman Sharma",{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":39,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Children's Orthopaedic and Scoliosis Surgery Associates, LLP","NOT_YET_RECRUITING","St. Petersburg","Florida","33701",{"type":41,"coordinates":59},[60,61],-82.67927,27.77086,{"lat":61,"lon":60},[64,68,71],{"name":65,"role":26,"phone":66,"phoneExt":19,"email":67},"Ryan E. Fitzgerald, MD","813-506-5511","rfitzgerald@chortho.com",{"name":69,"role":26,"phone":66,"phoneExt":19,"email":70},"Priscilla Martinez","pmartinez@chortho.com",{"name":65,"role":23,"phone":19,"phoneExt":19,"email":19},{"facility":73,"status":54,"city":55,"state":56,"zip":57,"country":39,"cosmosGeoPoint":74,"geoPoint":76,"contacts":77},"Johns Hopkins All Children's Hospital",{"type":41,"coordinates":75},[60,61],{"lat":61,"lon":60},[78,82,86],{"name":79,"role":26,"phone":80,"phoneExt":19,"email":81},"Frederick Kuo, MD","410-929-2123","frederick.kuo@jhmi.edu",{"name":83,"role":26,"phone":84,"phoneExt":19,"email":85},"Janelle Maddox-Regis, MS, CIP","443-927-1476","Jmaddox3@jhmi.edu",{"name":79,"role":23,"phone":19,"phoneExt":19,"email":19},{"facility":88,"status":35,"city":89,"state":90,"zip":91,"country":39,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Riley Children's Hospital","Indianapolis","Indiana","46202",{"type":41,"coordinates":93},[94,95],-86.15804,39.76838,{"lat":95,"lon":94},[98,101],{"name":99,"role":26,"phone":19,"phoneExt":19,"email":100},"Senthil Packiasabhapathy, MD","sepack@iu.edu",{"name":99,"role":23,"phone":19,"phoneExt":19,"email":19},{"facility":103,"status":35,"city":104,"state":105,"zip":106,"country":39,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"UPMC Children's Hospital","Pittsburgh","Pennsylvania","15224",{"type":41,"coordinates":108},[109,110],-79.99589,40.44062,{"lat":110,"lon":109},[113],{"name":22,"role":26,"phone":114,"phoneExt":19,"email":28},"412-647-2994",{"type":116,"investigatorFullName":117,"investigatorTitle":118,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"SPONSOR_INVESTIGATOR","Senthil Sadhasivam","Professor",[120],{"name":121,"class":122},"National Institute on Drug Abuse (NIDA)","NIH","100467503",false,"NCT05367609","Personalized Perioperative Analgesia Platform (PPAP) for Pediatric Spine Fusion Surgery (sIRB)","PPAP Spine","Inclusion Criteria:\n\n* Children ages 10 to 21\n* ASA physical status 1 to 3\n* Undergoing Posterior-Lateral Spinal Fusion\n* Receives in-patient opioids\n* Prescribed opioids at discharge\n\nExclusion Criteria:\n\n* Serious illness\n* Preoperative severe pain\n* Preoperative opioid use or misuse","ALL","10 Years","21 Years",{"count":133,"type":134},300,"ESTIMATED","INTERVENTIONAL",[137],"NA","The purpose of this collaborative CTSA application is to develop an innovative perioperative precision analgesia platform (PPAP) to improve analgesia and reduce serious immediate and long-term adverse outcomes of perioperative opioids in children undergoing painful surgery.",[140,141],"PPAP","Spine Fusion",[140,143,144],"Pediatric","Spine Fusion Surgery","2026-04-07",{"date":147,"type":148},"2026-04-13","ACTUAL",{"date":150,"type":148},"2022-09-20",{"date":152,"type":134},"2027-10-30",{"name":117,"class":6},5]