[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585550":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":74,"collaborators":26,"id":76,"slug":26,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":26,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":26,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":98,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Texas Tech University Health Sciences Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ketamine Group","EXPERIMENTAL","Participants in this group will receive a single intraoperative dose of intravenous (IV) ketamine (0.5 mg\u002Fkg) within 30 minutes of anesthesia induction. The intervention is designed to assess ketamine's effects on postoperative pain, opioid use, and symptoms of depression and PTSD in patients undergoing surgical fixation for musculoskeletal trauma.",[13],"Drug: Ketamine",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","ACTIVE_COMPARATOR","Participants in this group will receive standard general anesthesia without ketamine. This group serves as a comparison to evaluate the effectiveness of ketamine on postoperative pain levels, opioid consumption, and psychological recovery following orthopedic trauma surgery.",[19],"Drug: standard general anesthesia",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Ketamine","Participants in this group will receive a single intravenous (IV) dose of ketamine at 0.5 mg\u002Fkg, administered within 30 minutes of anesthesia induction during surgical fixation for musculoskeletal trauma. The purpose of the intervention is to evaluate ketamine's effect on postoperative pain, opioid consumption, and psychological recovery, including symptoms of depression and post-traumatic stress disorder (PTSD).",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"standard general anesthesia","Participants in this group will receive standard general anesthesia during surgical fixation for musculoskeletal trauma. No ketamine will be administered. This group serves as a comparison to evaluate the effects of ketamine on pain, opioid use, and psychological recovery.",[15],[32],{"name":33,"affiliation":34,"role":35},"Max Evan Davis, MD","Texas Tech University Health Sciences Center Department of Orthopaedic Surgery,","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Evan J Hernandez, MBA","CONTACT","8067436846","evan.j.hernandez@ttuhsc.edu",[43,63],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Texas Tech University Health Sciences Center Lubbock","RECRUITING","Lubbock","Texas","79415","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-101.85517,33.57786,{"lat":55,"lon":54},[58,61],{"name":59,"role":39,"phone":60,"phoneExt":26,"email":41},"Evan J. Hernandez Project Manager, MBA","806-743-6846",{"name":62,"role":35,"phone":26,"phoneExt":26,"email":26},"Max E. Davis Assistant Professor, MD",{"facility":64,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":65,"geoPoint":67,"contacts":68},"University Medical Center",{"type":52,"coordinates":66},[54,55],{"lat":55,"lon":54},[69,73],{"name":70,"role":39,"phone":71,"phoneExt":26,"email":72},"Ami Knox Program Director of Clinical Research, MBA","806-761-0575","ami.knox@umchealthsystem.com",{"name":62,"role":35,"phone":26,"phoneExt":26,"email":26},{"type":75,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100585550",false,"NCT06903819","Ketamine for Pain, Opioid Use, and Mental Health in Orthopedic Trauma Patients","Ketamine's Impact on Opioid Use, Pain, and Mental Health in Polytraumatized Orthopedic Patients: A Randomized Controlled Trial (KOPM)","Inclusion Criteria:\n\n* Adults aged 18-65\n* Undergoing acute operative fixation for musculoskeletal trauma\n* Injury Severity Score (ISS) greater than 15\n* Ability to provide informed consent (or consent provided by a legally authorized representative)\n\nExclusion Criteria:\n\n* Age under 18 or over 65\n* Use of ketamine for preoperative or postoperative sedation\n* Known allergy or contraindication to ketamine\n* Prior unsuccessful ketamine therapy for major depressive disorder (MDD) or PTSD\n* Severe psychiatric conditions or psychotic features\n* History of dementia or glaucoma\n* Currently engaged in trauma-focused cognitive behavioral therapy or PTSD psychotherapy started within the past 3 months","ALL","18 Years","65 Years",{"count":86,"type":87},90,"ESTIMATED","INTERVENTIONAL",[90],"PHASE4","The goal of this clinical trial is to learn if ketamine, given during surgery, can help improve recovery for adults with serious orthopedic trauma. The study will test whether ketamine reduces pain, lowers the need for opioids, and improves mental health outcomes like depression and post-traumatic stress disorder (PTSD).\n\nThe main questions it aims to answer are:\n\nDoes ketamine reduce pain after surgery compared to standard anesthesia?\n\nDoes ketamine reduce the amount of opioids patients need for pain control?\n\nDoes ketamine improve symptoms of depression and PTSD after orthopedic trauma?\n\nResearchers will compare patients who receive ketamine during surgery with those who receive standard anesthesia without ketamine to see if ketamine helps improve both physical and psychological recovery.\n\nParticipants will:\n\nBe randomly assigned to receive either a single dose of ketamine or standard anesthesia during surgery.\n\nReport their pain using a simple pain scale (Visual Analog Scale, VAS).\n\nComplete short surveys about mood and mental health (PHQ-9 for depression and PCL-5 for PTSD) at several time points after surgery.\n\nAllow the research team to review their electronic medical records to measure opioid prescriptions during recovery.\n\nAttend follow-up visits in clinic or by secure telehealth (e.g., Zoom) at 1-7 days, 2-3 weeks, 6 weeks, 3 months, and 6 months after surgery",[93,94,95,96,97],"Orthopedic Trauma Surgery Patients","Postoperative Pain","Opioid Use","Depression","Post-traumatic Stress Disorder (PTSD)",[23,99,94,100,96,101,102,103],"Orthopedic Trauma","Opioid Reduction","PTSD","Musculoskeletal Injury","Trauma Surgery","2026-03-19",{"date":106,"type":107},"2026-03-24","ACTUAL",{"date":109,"type":107},"2025-11-06",{"date":111,"type":87},"2028-05",{"name":5,"class":6},2]