RecruitingPhase 4NCT06903819

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

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

Sponsor

Texas Tech University Health Sciences Center

Enrollment

90 participants

Start Date

Nov 6, 2025

Study Type

INTERVENTIONAL

Conditions

Opioid Use Postoperative Pain Depression Orthopedic Trauma Surgery Patients

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether low-dose ketamine — a medication already used for pain and mood — can reduce opioid use and improve mental health outcomes in people recovering from serious bone and joint injuries requiring surgery. **You may be eligible if...** - You are between 18 and 65 years old - You are having emergency surgery to repair a bone or joint injury - Your injury is considered severe (Injury Severity Score above 15) - You can give consent yourself or have someone who can do so on your behalf **You may NOT be eligible if...** - You are under 18 or over 65 - You have a known allergy or other medical reason to avoid ketamine - Ketamine was already tried for depression or PTSD without success - You have a severe psychiatric condition or psychosis - You have a history of dementia or glaucoma - You are currently enrolled in trauma-focused therapy or PTSD counseling started in the past 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKetamine

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).

DRUGstandard 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.