Actively Recruiting
Ketamine's Impact on Opioid Use, Pain, and Mental Health in Polytraumatized Orthopedic Patients: A Randomized Controlled Trial
Led by Texas Tech University Health Sciences Center ยท Updated on 2026-03-24
90
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating if ketamine given during surgery can improve recovery in adults with serious orthopedic trauma. The study aims to see whether ketamine reduces pain after surgery, lowers the need for opioid pain medications, and improves mental health outcomes like depression and post-traumatic stress disorder (PTSD). This is a single-blind randomized controlled trial comparing ketamine to standard anesthesia in adults aged 18 to 65 undergoing surgical fixation for musculoskeletal trauma. Participants will be randomly assigned to receive either a single intravenous dose of ketamine (0.5 mg/kg) within 30 minutes of anesthesia induction or standard general anesthesia without ketamine. The anesthesia team knows which treatment is given for safety, but participants and postoperative care teams do not. The trial focuses on assessing ketamine's effects on pain, opioid use, and psychological recovery. During the study, participants will report their pain using a Visual Analog Scale at multiple time points from 1 day to 6 months after surgery. They will also complete questionnaires about depression and PTSD symptoms at these intervals. Researchers will track opioid use from electronic medical records. Follow-up visits can be done in clinic or via secure telehealth at 1-7 days, 2-3 weeks, 6 weeks, 3 months, and 6 months post-surgery to monitor recovery and safety.
CONDITIONS
Brief Title
Ketamine for Pain, Opioid Use, and Mental Health in Orthopedic Trauma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18-65
- Undergoing acute operative fixation for musculoskeletal trauma
- Injury Severity Score greater than 15
- Ability to provide informed consent or consent by legally authorized representative
You will not qualify if you...
- 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 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day (surgery day)
Participants receive a single intravenous dose of ketamine or standard anesthesia during surgery for musculoskeletal trauma.
1 intraoperative visit
Duration - Up to 6 months post-surgery
Participants complete assessments of pain, opioid use, and mental health symptoms at multiple time points after surgery.
Visits at 1-7 days, 2-3 weeks, 6 weeks, 3 months, and 6 months postoperatively (in-person or telehealth)
Trial Site Locations
Total: 2 locations
1
Texas Tech University Health Sciences Center Lubbock
Lubbock, Texas, United States, 79415
Actively Recruiting
2
University Medical Center
Lubbock, Texas, United States, 79415
Actively Recruiting
Research Team
E
Evan J Hernandez, MBA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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