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

March 19, 2026 updated by: Texas Tech University Health Sciences Center

Ketamine's Impact on Opioid Use, Pain, and Mental Health in Polytraumatized Orthopedic Patients: A Randomized Controlled Trial (KOPM)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 indicate that ketamine may reduce PTSD-related symptoms by influencing brain pathways involved in stress and memory. However, despite these promising effects, ketamine has not been fully integrated into trauma care protocols, in part due to limited large-scale data in orthopedic populations.

This single-blind randomized controlled trial is designed to evaluate whether a single intraoperative dose of IV ketamine (0.5 mg/kg) improves recovery in adults undergoing surgical fixation for musculoskeletal trauma. Participants will be randomly assigned to receive either ketamine or standard anesthesia without ketamine. While the anesthesia team will be aware of group assignment to ensure patient safety, participants and postoperative care teams will remain blinded.

The study will measure multiple aspects of recovery, including:

Postoperative pain intensity, using a validated Visual Analog Scale (VAS).

Opioid consumption during recovery, quantified from electronic medical records and converted to morphine milligram equivalents (MME).

Psychological outcomes, including symptoms of depression and PTSD, assessed with the PHQ-9 and PCL-5 surveys at defined follow-up intervals.

Follow-up assessments will occur at several time points after surgery, ranging from the early postoperative period (1-7 days) to longer-term recovery (up to 6 months). To accommodate patients unable to attend in-person visits, telehealth-based follow-up is available.

By focusing on both physical and psychological outcomes, this trial aims to determine whether ketamine can serve as a dual-purpose intervention in orthopedic trauma care. Results will provide evidence on the feasibility and potential benefits of incorporating ketamine into standard surgical practice for patients with severe musculoskeletal injuries.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Lubbock, Texas, United States, 79415
        • Recruiting
        • Texas Tech University Health Sciences Center Lubbock
        • Contact:
        • Principal Investigator:
          • Max E. Davis Assistant Professor, MD
      • Lubbock, Texas, United States, 79415
        • Recruiting
        • University Medical Center
        • Principal Investigator:
          • Max E. Davis Assistant Professor, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketamine Group
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.
Drug: Ketamine
Participants in this group will receive a single intravenous (IV) dose of ketamine at 0.5 mg/kg, 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).
Active Comparator: Control Group
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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity (VAS)
Time Frame: 1-7 days, 2-3 weeks (±1 week), 6 weeks (±2 weeks), 3 months (±3 weeks), and 6 months (±5 weeks) postoperatively.
Pain intensity will be assessed using the Visual Analog Scale (VAS), a validated 0-100 continuous scale (or 0-10 categorical equivalent). Higher scores indicate greater pain. This outcome evaluates whether intraoperative ketamine reduces postoperative pain compared to standard anesthesia.
1-7 days, 2-3 weeks (±1 week), 6 weeks (±2 weeks), 3 months (±3 weeks), and 6 months (±5 weeks) postoperatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Opioid Consumption (MME)
Time Frame: 1-7 days, 2-3 weeks (±1 week), 6 weeks (±2 weeks), 3 months (±3 weeks), and 6 months (±5 weeks) postoperatively.
Opioid use will be quantified from prescription records in the electronic medical record (EMR) and converted into morphine milligram equivalents (MME). This will assess whether intraoperative ketamine reduces opioid requirements compared to the control group.
1-7 days, 2-3 weeks (±1 week), 6 weeks (±2 weeks), 3 months (±3 weeks), and 6 months (±5 weeks) postoperatively.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression Symptoms (PHQ-9)
Time Frame: 1-7 days, 2-3 weeks (±1 week), 6 weeks (±2 weeks), 3 months (±3 weeks), and 6 months (±5 weeks) postoperatively.
Depression severity will be measured with the Patient Health Questionnaire-9 (PHQ-9), a validated self-report survey. Higher scores indicate greater depressive symptom burden.
1-7 days, 2-3 weeks (±1 week), 6 weeks (±2 weeks), 3 months (±3 weeks), and 6 months (±5 weeks) postoperatively.
PTSD Symptoms (PCL-5)
Time Frame: 1-7 days, 2-3 weeks (±1 week), 6 weeks (±2 weeks), 3 months (±3 weeks), and 6 months (±5 weeks) postoperatively.
Post-traumatic stress disorder symptoms will be measured using the PTSD Checklist for DSM-5 (PCL-5), a validated self-report survey. Higher scores indicate more severe PTSD symptoms.
1-7 days, 2-3 weeks (±1 week), 6 weeks (±2 weeks), 3 months (±3 weeks), and 6 months (±5 weeks) postoperatively.
Adverse Events Related to Ketamine
Time Frame: Monitored continuously through 6 months postoperatively.
Frequency and severity of adverse events (e.g., nausea, vomiting, dizziness, hypertension, dissociative symptoms, allergic reactions, or prolonged psychotomimetic effects) will be recorded. Participants scoring ≥20 on the PHQ-9 or ≥50 on the PCL-5 will trigger automated alerts and referral to psychiatric care. All serious adverse events (SAEs) related or possibly related to ketamine will be documented.
Monitored continuously through 6 months postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Tech University Health Sciences Center

Investigators

  • Principal Investigator: Max Evan Davis, MD, Texas Tech University Health Sciences Center Department of Orthopaedic Surgery,

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

April 1, 2025

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-FY2025-75

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only aggregate results will be published or shared in accordance with ethical guidelines.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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