[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sharon Levy\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100543018","adolescent-outcomes-of-post-operative-opioid-exposure-100543018",false,"NCT06350409","Adolescent Outcomes of Post-operative Opioid EXposure","APEX","Adolescent Inclusion Criteria\n\n1. Adolescents between the ages of 12 to 17 years old, inclusive, who are scheduled to undergo a scheduled surgical procedure with a greater than 90% likelihood of requiring opioid analgesia for at least 48 hours post-operatively (as an inpatient) or discharged home with at least a 48-hour supply of prescription opioids.\n\n   • Opioid prescribing practices vary by institution; therefore, eligible surgical procedures will be determined on a site-by-site basis.\n2. Adolescents willing and able to provide informed assent and have a parent\u002Fcaregiver willing to provide informed consent.\n\nParent\u002FCaregiver Inclusion Criteria\n\n1. Parent or legal guardian of an eligible adolescent.\n2. Parent or legal guardian willing and able to provide written informed consent.\n\nAdolescent Exclusion Criteria\n\nAdolescents meeting any of the following criteria will be excluded from study participation:\n\n1. Adolescents who have been prescribed opioids in the past 2 years for pain due to a chronic medical condition.\n2. Adolescents who have a current chronic medical condition that requires ongoing opioid pain management and treatment such as sickle cell disease, arthritis, or cancer.\n3. Adolescents who do not have a caregiver who is willing to co-participate in the study.\n4. Adolescents who cannot speak or read English at a 4th-grade level as determined by medical or research staff.\n5. Adolescents who are currently in the custody of the Department of Youth Services, jail\u002Fprison, or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities.\n6. Adolescents who are currently in the custody of the Department of Children and Families or living with a foster family.\n7. Adolescents who are currently pregnant or parenting.\n8. Adolescents that self or parent report of ever having been diagnosed with opioid use disorder, or prescribed buprenorphine, methadone, or naltrexone to treat opioid use disorder.\n9. Adolescents who are currently enrolled in an intervention study that aims to impact opioid prescription or pain management pre-, peri-, or post-operatively.\n\nParent\u002FCaregiver Exclusion Criteria\n\nParents\u002FCaregivers meeting any of the following criteria will be excluded from study participation:\n\n1. Parents\u002FCaregivers who cannot speak or read English or Spanish at a 4th grade level as determined by medical or research staff.\n2. Parents\u002FCaregivers that are currently incarcerated.\n3. Parents\u002FCaregivers that are in physical or mental distress that precludes study participation as determined by clinical or study staff.","ALL","12 Years","17 Years",{"count":20,"type":21},20000,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to examine the factors associated with the transition from medical exposure to opioids with \"signposts\" of future opioid use disorder among adolescent surgical patients. The main question aims to identify factors (moderators, mediators, and covariates) associated with risk factors for opioid use disorder (ROUD) in the 12 months following major surgery with opioid exposure among adolescents aged 12-17. Participants will be asked to complete electronic surveys pre- and post-operatively and approve the collection of peri-operative data from the Electronic Medical Record to assess correlations.",[25,26],"Opioid Use Disorder","Pain, Chronic",[28,29],"Adolescent Opioid Use","Post operative pain","RECRUITING","2026-03-16",{"date":33,"type":34},"2026-03-18","ACTUAL",{"date":36,"type":34},"2024-11-12",{"date":38,"type":21},"2028-02",{"name":40,"class":41},"Sharon Levy","OTHER",5,""]