Psychiatry
PHASE4
● Phase IV
Ketamine in Orthopedic Trauma: Potential to Reduce Pain and Opioid Use
ClinicalTrials.gov
Published March 27, 2026
Texas Tech University Health Sciences Center
NCT06903819 ↗
This ongoing Phase 4 clinical trial, sponsored by Texas Tech University Health Sciences Center, aims to evaluate the efficacy of intraoperative ketamine in improving recovery outcomes for adults undergoing orthopedic trauma surgery. The study enrolls 90 participants, who are randomly assigned to receive either a single dose of ketamine or standard general anesthesia during surgery. The primary endpoint is postoperative pain intensity, assessed using the Visual Analog Scale (VAS). Secondary endpoints include opioid consumption, as well as mental health outcomes measured by the PHQ-9 for depression and PCL-5 for PTSD. Participants' opioid prescriptions will be monitored through electronic medical records, and follow-up assessments will occur at multiple time points up to 6 months post-surgery. While ketamine is known for its anesthetic properties, it may offer additional benefits in reducing acute pain, decreasing opioid requirements, and improving depressive symptoms. The study's findings could inform new approaches to managing both physical and psychological recovery in this patient population. Safety and adverse event data will be collected, though specific statistics and outcomes are not yet available.
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· Auto-published
This study involves patients who have had serious injuries requiring orthopedic surgery. Researchers are testing if giving ketamine, a drug often used for anesthesia, during surgery can help these patients recover better. They want to find out if ketamine can reduce pain after surgery, lower the amount of opioid painkillers needed, and improve symptoms of depression and post-traumatic stress disorder (PTSD). If ketamine proves effective, it could mean less pain and better mental health for patients recovering from serious injuries. However, it’s important to remember that this study is still in the early stages, and results are not yet available. Patients will be monitored closely to see how they respond to ketamine compared to standard anesthesia. This research could lead to new ways to help patients heal both physically and mentally after traumatic injuries.
What this means for you: Ketamine may help reduce pain and improve mental health for patients after serious injuries.
View Original Abstract ↓
Status: RECRUITING | Phase: PHASE4
Condition(s): Orthopedic Trauma Surgery Patients, Postoperative Pain, Opioid Use, Depression, Post-traumatic Stress Disorder (PTSD)
Intervention(s): Ketamine (DRUG), standard general anesthesia (DRUG)
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
Detailed: Orthopedic trauma patients often face challenges in both physical and psychological recovery following injury. Pain control is difficult, as effective pain relief must be balanced against the risks of opioid dependence. In addition, rates of depression and post-traumatic stress disorder (PTSD) are high in this population, further complicating recovery. These overlapping challenges highlight the need for new approaches that address both pain and mental health outcomes.
Ketamine, a commonly used anesthetic, has properties that may benefit trauma patients beyond its routine role in surgery. Evidence suggests that low-dose intravenous (IV) ketamine can reduce acute postoperative pain, decrease the need for opioid medications, and have rapid effects on depressive symptoms. Some studies also in
Primary Outcome(s): Pain Intensity (VAS)
Enrollment: 90 (ESTIMATED)
Lead Sponsor: Texas Tech University Health Sciences Center
Start: 2025-11-06 | Primary Completion: 2027-05