Ketamine during orthopedic trauma surgery to reduce pain, opioid use, and improve mood
Ketamine's Impact on Opioid Use, Pain, and Mental Health in Polytraumatized Orthopedic Patients: A Randomized Controlled Trial (KOPM)
This study will try a single dose of ketamine during surgery to see if it lowers pain and opioid needs and improves depression and PTSD symptoms in adults having major orthopedic trauma surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Texas Tech University Health Sciences Center Academic / other |
| Locations | 2 sites (Lubbock, Texas and 1 other locations) |
| Trial ID | NCT06903819 on ClinicalTrials.gov |
What this trial studies
This single-blind randomized trial will enroll adults (ages 18–65) undergoing operative fixation for serious musculoskeletal trauma (ISS >15) and randomly assign them to receive a single intraoperative IV dose of ketamine (0.5 mg/kg) or standard anesthesia without ketamine. The anesthesia team will know assignment for safety, but postoperative assessors and patients will be blinded to group when possible. Outcomes include patient-reported pain using a visual analog scale, postoperative opioid consumption, and measures of depression and PTSD symptoms over follow-up. The trial is conducted at two sites in Lubbock, Texas (Texas Tech University Health Sciences Center and University Medical Center).
Who should consider this trial
Good fit: Adults 18–65 undergoing acute operative fixation for musculoskeletal trauma with an Injury Severity Score greater than 15 and able to provide informed consent are ideal candidates.
Not a fit: People younger than 18 or older than 65, those with contraindications or allergies to ketamine, prior ineffective ketamine for MDD/PTSD, severe psychotic disorders, or recent trauma-focused PTSD psychotherapy are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, a single intraoperative dose of ketamine could reduce postoperative pain and opioid use while improving depressive and PTSD symptoms after serious orthopedic injury.
How similar studies have performed: Smaller trials and research in other surgical and psychiatric populations have shown ketamine can reduce acute pain and rapidly improve depressive symptoms, but large randomized data specifically in orthopedic trauma patients are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lubbock, Texas and 1 other locations
- Texas Tech University Health Sciences Center Lubbock — Lubbock, Texas, United States (Recruiting)
- University Medical Center — Lubbock, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Max Evan Davis, MD — Texas Tech University Health Sciences Center Department of Orthopaedic Surgery,
- Study coordinator: Evan J Hernandez, MBA
- Email: evan.j.hernandez@ttuhsc.edu
- Phone: 8067436846
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.