[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100467503":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":20,"centralContacts":24,"locations":32,"responsibleParty":116,"collaborators":120,"id":124,"slug":125,"hasResults":126,"nctId":127,"briefTitle":128,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":126,"sex":131,"minAge":132,"maxAge":133,"enrollmentInfo":134,"targetDuration":19,"studyType":137,"phases":138,"briefSummary":140,"conditions":141,"keywords":144,"overallStatus":35,"whyStopped":19,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"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",[33,53,73,88,103],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"University of California","RECRUITING","San Francisco","California","38456","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-122.41942,37.77493,{"lat":45,"lon":44},[48,51],{"name":49,"role":26,"phone":19,"phoneExt":19,"email":50},"Ridhima Jain","Ridhma.jain@ucsf.edu",{"name":52,"role":23,"phone":19,"phoneExt":19,"email":19},"Anshuman Sharma",{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":39,"countryCode":40,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Children's Orthopaedic and Scoliosis Surgery Associates, LLP","NOT_YET_RECRUITING","St. Petersburg","Florida","33701",{"type":42,"coordinates":60},[61,62],-82.67927,27.77086,{"lat":62,"lon":61},[65,69,72],{"name":66,"role":26,"phone":67,"phoneExt":19,"email":68},"Ryan E. Fitzgerald, MD","813-506-5511","rfitzgerald@chortho.com",{"name":70,"role":26,"phone":67,"phoneExt":19,"email":71},"Priscilla Martinez","pmartinez@chortho.com",{"name":66,"role":23,"phone":19,"phoneExt":19,"email":19},{"facility":74,"status":55,"city":56,"state":57,"zip":58,"country":39,"countryCode":40,"cosmosGeoPoint":75,"geoPoint":77,"contacts":78},"Johns Hopkins All Children's Hospital",{"type":42,"coordinates":76},[61,62],{"lat":62,"lon":61},[79,83,87],{"name":80,"role":26,"phone":81,"phoneExt":19,"email":82},"Frederick Kuo, MD","410-929-2123","frederick.kuo@jhmi.edu",{"name":84,"role":26,"phone":85,"phoneExt":19,"email":86},"Janelle Maddox-Regis, MS, CIP","443-927-1476","Jmaddox3@jhmi.edu",{"name":80,"role":23,"phone":19,"phoneExt":19,"email":19},{"facility":89,"status":35,"city":90,"state":91,"zip":92,"country":39,"countryCode":40,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Riley Children's Hospital","Indianapolis","Indiana","46202",{"type":42,"coordinates":94},[95,96],-86.15804,39.76838,{"lat":96,"lon":95},[99,102],{"name":100,"role":26,"phone":19,"phoneExt":19,"email":101},"Senthil Packiasabhapathy, MD","sepack@iu.edu",{"name":100,"role":23,"phone":19,"phoneExt":19,"email":19},{"facility":104,"status":35,"city":105,"state":106,"zip":107,"country":39,"countryCode":40,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"UPMC Children's Hospital","Pittsburgh","Pennsylvania","15224",{"type":42,"coordinates":109},[110,111],-79.99589,40.44062,{"lat":111,"lon":110},[114],{"name":22,"role":26,"phone":115,"phoneExt":19,"email":28},"412-647-2994",{"type":117,"investigatorFullName":118,"investigatorTitle":119,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"SPONSOR_INVESTIGATOR","Senthil Sadhasivam","Professor",[121],{"name":122,"class":123},"National Institute on Drug Abuse (NIDA)","NIH","100467503","personalized-perioperative-analgesia-platform-ppap-for-pediatric-spine-fusion-surgery-sirb-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":135,"type":136},300,"ESTIMATED","INTERVENTIONAL",[139],"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.",[142,143],"PPAP","Spine Fusion",[142,145,146],"Pediatric","Spine Fusion Surgery","2026-04-07",{"date":149,"type":150},"2026-04-13","ACTUAL",{"date":152,"type":150},"2022-09-20",{"date":154,"type":136},"2027-10-30",{"name":118,"class":6},5]