Study of Ketamine to Improve Pain, Reduce Opioid Use, and Support Mental Health in Adults Undergoing Orthopedic Trauma Surgery
Led by Texas Tech University Health Sciences Center · Updated on 2026-03-24
90
Participants Needed
2
Research Sites
52 weeks
Total Duration
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 mgkg 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 ketamines 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
Research Team
E
Evan J Hernandez, MBA
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
Ketamine (investigated)
Standard anesthesia (control)
What it is
An investigational single intravenous bolus of ketamine 0.5 mg/kg given during anesthesia induction in orthopedic trauma surgery
Standard general anesthesia without ketamine
Role in trial
Investigational arm evaluating ketamine’s effects on pain, opioid use, and psychological outcomes
Active comparator arm using standard anesthesia to assess baseline recovery
Primary use
Studied as an adjunct during surgery to reduce postoperative pain, opioid requirement, and depressive/PTSD symptoms
Represents usual intraoperative anesthesia without ketamine to assess standard recovery trajectory
How it is given or performed
Single IV bolus of ketamine at 0.5 mg per kg given within 30 minutes of anesthesia induction
Standard general anesthesia with no ketamine administered
Evidence status
Preliminary external evidence supports perioperative IV ketamine reduces opioid use postoperatively and may modestly reduce pain in early recovery
Standard anesthesia is established current practice without ketamine adjunct
Important risks
Safety profile appears comparable to opioid‑only regimens with no consistent increase in adverse events; some studies note less sedation and pruritus
Safety reflects standard anesthesia risks, without ketamine‑associated effects
Important limitations
Evidence on pain reduction is variable; benefits may be time‑limited and dosing protocols vary
Applicable to perioperative standard anesthesia; does not address mental health outcomes without intervention
Patient impact
May reduce postoperative opioid consumption and opioid‑related side effects, with possible early pain reduction
Represents typical recovery path without ketamine effect
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 18Years - 65Years
All Genders
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
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single day (surgery day)
Participants receive a single intravenous dose of ketamine or standard anesthesia during surgery for musculoskeletal trauma.
1 intraoperative visit
Post-operative Follow-up
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)
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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Published Research Related To This Trial
Effect of intraoperative ketamine on pain, opioid use, and psychological recovery in orthopedic trauma patients (KOPM trial): protocol for a randomized, single-blind trial.
Camas Curran, Evan J Hernandez, Jennifer Hudnall...