[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05367609":3,"trial-entities:NCT05367609":162,"trial-summary:NCT05367609":166},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":52,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":60,"eligibility_criteria":61,"std_ages":73,"locations":76,"central_contacts":151,"overall_officials":157,"references":160,"see_also_links":161},"NCT05367609","STUDY21090075","Personalized Perioperative Analgesia Platform (PPAP) for Pediatric Spine Fusion Surgery (sIRB)","RECRUITING","2027-10-30","2025-09","2026-04-13","2022-09-20","Senthil Sadhasivam","OTHER",true,"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.","Aim 1. Develop and implement a perioperative precision analgesia platform (PPAP) by linking genomics to opioid metabolism, CPIC guidelines, precision dosing, clinical safety, and personalizing analgesia.\n\nAim 2. Implement and evaluate PPAP in children undergoing major inpatient surgery, posterior spinal fusion (PSF)\n\n1. Determine genetic factors predisposing children to immediate and long-term postoperative methadone and oxycodone related adverse effects including RD, PONV, opioid dependence, and CPSP\n\n   The PI postulate that specific CYP2B6, ABCB1, OPRM1, FAAH, and CYP2D6 variants identify children at risk for poor pain relief, RD, PONV, opioid dependence, and CPSP in the postoperative period.\n2. Determine genetic variants-based perioperative dosing and outpatient prescribing of opioids\n\nThe PI hypothesize that CYP2B6 and CYP2D6 variants will explain pharmacokinetic variations of methadone and oxycodone, determine the right doses, and implement precision opioid use for optimal clinical outcomes",[18,19],"PPAP","Spine Fusion",[18,21,22],"Pediatric","Spine Fusion Surgery","INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},300,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DIAGNOSTIC_TEST","Preoperative Genotyping","Genotype based risk prediction and personalized pain management",[36],"Children undergoing Spine Fusion Surgery",[38,42,46,50],{"measure":39,"description":40,"timeFrame":41},"Look at genetic factors predisposing children to immediate postoperative opioid-adverse effects Respiratory Depression (RD) and Postoperative Nausea and Vomiting (PONV)","The investigators will look at specific CYP2D6, ABCB1, FAAH, OPRM1, and COMT variants to find correlations with children who experience RD and PONV in the immediate post-surgical period (4 days) in the hospital","Immediately post-surgery up to 4 days in patient",{"measure":43,"description":44,"timeFrame":45},"Look at genetic factors predisposing children to postoperative opioid-adverse effects Respiratory Depression (RD) and Postoperative Nausea and Vomiting (PONV) at genetic factors predisposing children to inadequate surgical pain relief with oxycodone","The investigators will look at specific CYP2D6, ABCB1, FAAH, OPRM1, and COMT variants to find correlations with children who experience RD and PONV in the post-surgical period at home up to 1-year","At home up to 1 year post-surgery",{"measure":47,"description":48,"timeFrame":49},"Look at genetic factors predisposing children to inadequate surgical pain relief with oxycodone","The investigators will look at specific CYP2D6, ABCB1, FAAH, OPRM1, and COMT variants to find correlations with children who experience poor pain relief in the immediate post-surgical period (4 days) in the hospital. Poor pain relief will be determined using the Numerical Rating Scale (NRS) which runs on a 0-10 scale; 0 being no pain at all, 10 being the worst pain imaginable.","Immediately post-surgery",{"measure":47,"description":51,"timeFrame":45},"The investigators will look at specific CYP2D6, ABCB1, FAAH, OPRM1, and COMT variants to find correlations with children who experience poor pain relief in the post-surgical period at home up to 1-year. Poor pain relief will be determined using the Numerical Rating Scale (NRS) which runs on a 0-10 scale; 0 being no pain at all, 10 being the worst pain imaginable.",[53],{"measure":54,"description":55,"timeFrame":56},"Look at the impact of CYP2D6 variants on oxycodone's clinical dosing in children to see if specific variants correlate with a need for lower or higher doses of analgesic","The investigators will look at CYP2D6 variants to find correlations in oxycodone's PK sampling and the need for dose adjustments that lead to desired clinical outcomes in children undergoing major inpatient surgeries. Oxycodone will be measured by the IU CTSI's Clinical Pharmacology Analytical Core (CPAC) laboratory using a validated LC\u002FMS\u002FMS as-say,201 and plasma alpha-1 acid glycoprotein (AAG) will be measured using a HPLC\u002FUV assay. Study team will track the subjects choices from their signed consent form regarding PK collections.","Pre-operative to post-operative day 2","ALL","10 Years","21 Years",false,{"inclusion":62,"exclusion":68,"raw_text":72},[63,64,65,66,67],"Children ages 10 to 21","ASA physical status 1 to 3","Undergoing Posterior-Lateral Spinal Fusion","Receives in-patient opioids","Prescribed opioids at discharge",[69,70,71],"Serious illness","Preoperative severe pain","Preoperative opioid use or misuse","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",[74,75],"CHILD","ADULT",[77,94,112,125,138],{"facility":78,"status":7,"city":79,"state":80,"zip":81,"country":82,"contacts":83,"geoPoint":91},"University of California","San Francisco","California","38456","United States",[84,88],{"name":85,"role":86,"email":87},"Ridhima Jain","CONTACT","Ridhma.jain@ucsf.edu",{"name":89,"role":90},"Anshuman Sharma","PRINCIPAL_INVESTIGATOR",{"lat":92,"lon":93},37.77493,-122.41942,{"facility":95,"status":96,"city":97,"state":98,"zip":99,"country":82,"contacts":100,"geoPoint":109},"Children's Orthopaedic and Scoliosis Surgery Associates, LLP","NOT_YET_RECRUITING","St. Petersburg","Florida","33701",[101,105,108],{"name":102,"role":86,"phone":103,"email":104},"Ryan E. Fitzgerald, MD","813-506-5511","rfitzgerald@chortho.com",{"name":106,"role":86,"phone":103,"email":107},"Priscilla Martinez","pmartinez@chortho.com",{"name":102,"role":90},{"lat":110,"lon":111},27.77086,-82.67927,{"facility":113,"status":96,"city":97,"state":98,"zip":99,"country":82,"contacts":114,"geoPoint":124},"Johns Hopkins All Children's Hospital",[115,119,123],{"name":116,"role":86,"phone":117,"email":118},"Frederick Kuo, MD","410-929-2123","frederick.kuo@jhmi.edu",{"name":120,"role":86,"phone":121,"email":122},"Janelle Maddox-Regis, MS, CIP","443-927-1476","Jmaddox3@jhmi.edu",{"name":116,"role":90},{"lat":110,"lon":111},{"facility":126,"status":7,"city":127,"state":128,"zip":129,"country":82,"contacts":130,"geoPoint":135},"Riley Children's Hospital","Indianapolis","Indiana","46202",[131,134],{"name":132,"role":86,"email":133},"Senthil Packiasabhapathy, MD","sepack@iu.edu",{"name":132,"role":90},{"lat":136,"lon":137},39.76838,-86.15804,{"facility":139,"status":7,"city":140,"state":141,"zip":142,"country":82,"contacts":143,"geoPoint":148},"UPMC Children's Hospital","Pittsburgh","Pennsylvania","15224",[144],{"name":145,"role":86,"phone":146,"email":147},"Senthilkumar Sadhasivam, MD, MPH","412-647-2994","sadhasivams@upmc.edu",{"lat":149,"lon":150},40.44062,-79.99589,[152,154],{"name":145,"role":86,"phone":153,"email":147},"4126472994",{"name":155,"role":86,"email":156},"Dayana Alsamsam, BSPS, MSc","alsamsamd@upmc.edu",[158],{"name":145,"affiliation":159,"role":90},"University of Pittsburgh",[],[],{"nct_id":4,"conditions":163,"biomarkers":165},[164],"Spine fusion",[],{"nct_id":4,"found":14,"summary":167,"prompt_version":177},{"design":168,"status":169,"heading":170,"summary":171,"follow_up":172,"word_count":173,"commitments":174,"compensation":175,"drugs_mentioned":176},"This is an interventional study, meaning participants will receive a specific intervention (preoperative genotyping). It aims to enroll 300 participants.","completed","Personalized Pain Management for Pediatric Spine Fusion Surgery","This study is developing a personalized approach to pain management for children and young adults (ages 10-21) undergoing spine fusion surgery. It uses a \"Personalized Perioperative Analgesia Platform\" (PPAP) which involves genetic testing (genotyping) before surgery. The goal is to understand how your genes might affect your response to pain medications like oxycodone and methadone, and your risk of side effects such as breathing problems (respiratory depression) or nausea and vomiting after surgery. Researchers also want to see if this personalized approach can help reduce long-term issues like opioid dependence or ongoing pain. The study aims to enroll 300 participants who are generally healthy, receiving inpatient opioids, and prescribed opioids at discharge.","Participants will be followed immediately after surgery for up to 4 days, and then at home for up to 1 year post-surgery.",112,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]