NCT06903819 Ketamine for Pain, Opioid Use, and Mental Health in Orthopedic Trauma Patients
| NCT ID | NCT06903819 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Texas Tech University Health Sciences Center |
| Condition | Orthopedic Trauma Surgery Patients |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-11-06 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 90 participants in total. It began in 2025-11-06 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Max Evan Davis, MD
PRINCIPAL INVESTIGATOR
Texas Tech University Health Sciences Center Department of Orthopaedic Surgery,
Frequently Asked Questions
Who can join the NCT06903819 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Orthopedic Trauma Surgery Patients. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06903819 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06903819 currently recruiting?
Yes, NCT06903819 is actively recruiting participants. Contact the research team at evan.j.hernandez@ttuhsc.edu for enrollment information.
Where is the NCT06903819 trial being conducted?
This trial is being conducted at Lubbock, United States, Lubbock, United States.
Who is sponsoring the NCT06903819 clinical trial?
NCT06903819 is sponsored by Texas Tech University Health Sciences Center. The principal investigator is Max Evan Davis, MD at Texas Tech University Health Sciences Center Department of Orthopaedic Surgery,. The trial plans to enroll 90 participants.