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Recruiting Phase 4 NCT06903819

Ketamine for Pain, Opioid Use, and Mental Health in Orthopedic Trauma Patients

Trial Parameters

Condition Orthopedic Trauma Surgery Patients
Sponsor Texas Tech University Health Sciences Center
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 90
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2025-11-06
Completion 2027-05
Interventions
Ketaminestandard general anesthesia

Brief Summary

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). The main questions it aims to answer are: Does ketamine reduce pain after surgery compared to standard anesthesia? Does ketamine reduce the amount of opioids patients need for pain control? Does ketamine improve symptoms of depression and PTSD after orthopedic trauma? Researchers 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. Participants will: Be randomly assigned to receive either a single dose of ketamine or standard anesthesia during surgery. Report their pain using a simple pain scale (Visual Analog Scale, VAS). Complete short surveys about mood and mental health (PHQ-9 for depression and PCL-5 for PTSD) at several time points after surgery. Allow the research team to review their electronic medical records to measure opioid prescriptions during recovery. Attend 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

Eligibility Criteria

Inclusion Criteria: * Adults aged 18-65 * Undergoing acute operative fixation for musculoskeletal trauma * Injury Severity Score (ISS) greater than 15 * Ability to provide informed consent (or consent provided by a legally authorized representative) Exclusion Criteria: * Age under 18 or over 65 * Use of ketamine for preoperative or postoperative sedation * Known allergy or contraindication to ketamine * Prior unsuccessful ketamine therapy for major depressive disorder (MDD) or PTSD * Severe psychiatric conditions or psychotic features * History of dementia or glaucoma * Currently engaged in trauma-focused cognitive behavioral therapy or PTSD psychotherapy started within the past 3 months

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