Ketamine for Pain, Opioid Use, and Mental Health in Orthopedic Trauma Patients
Key facts
- Who runs it
- Texas Tech University Health Sciences Center
- Where
- Lubbock, United StatesSee the 2 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 90 people, planned
- Started
- 6 Nov 2025
- Expected to end
- May 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Ketamine
- standard general anesthesia
- Record updated
- 24 March 2026
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Prior unsuccessful ketamine therapy for major depressive disorder (MDD) or PTSD
- Currently engaged in trauma-focused cognitive behavioral therapy or PTSD psychotherapy started within the past 3 months
- Known allergy or contraindication to ketamine
- Severe psychiatric conditions or psychotic features
- History of dementia or glaucoma
- Age under 18 or over 65
- Use of ketamine for preoperative or postoperative sedation
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in United States
- Texas Tech University Health Sciences Center-LubbockLubbock, United StatesContact: Evan J. Hernandez Project Manager, MBATaking people
- University Medical CenterLubbock, United StatesContact: Ami Knox Program Director of Clinical Research, MBATaking people
About the trial
What the trial wants to find out
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).
Read full original descriptionShow less
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
The 2 groups in the trial
- Ketamine GroupTreatment being tested
Participants in this group will receive a single intraoperative dose of intravenous (IV) ketamine (0.5 mg/kg) 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.
Treatment: Ketamine
- Control GroupExisting treatment, for comparison
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.
Treatment: standard general anesthesia
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Ketamine's Impact on Opioid Use, Pain, and Mental Health in Polytraumatized Orthopedic Patients: A Randomized Controlled Trial (KOPM)
- Fit questions
- Built from NCT06903819, who can take part
- Publications
- Record updated
- 24 March 2026