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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTexas Tech University Health Sciences Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ketamine

    Drug

    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).

  • standard general anesthesia

    Drug

    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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Ketamine GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain Intensity (VAS)

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.

Time frame
1-7 days, 2-3 weeks (±1 week), 6 weeks (±2 weeks), 3 months (±3 weeks), and 6 months (±5 weeks) postoperatively.

Secondary outcomes

1

Postoperative Opioid Consumption (MME)

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.

Time frame
1-7 days, 2-3 weeks (±1 week), 6 weeks (±2 weeks), 3 months (±3 weeks), and 6 months (±5 weeks) postoperatively.

Other outcomes

1

Depression Symptoms (PHQ-9)

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.

Time frame
1-7 days, 2-3 weeks (±1 week), 6 weeks (±2 weeks), 3 months (±3 weeks), and 6 months (±5 weeks) postoperatively.
2

PTSD Symptoms (PCL-5)

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.

Time frame
1-7 days, 2-3 weeks (±1 week), 6 weeks (±2 weeks), 3 months (±3 weeks), and 6 months (±5 weeks) postoperatively.
3

Adverse Events Related to Ketamine

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.

Time frame
Monitored continuously through 6 months postoperatively.

Sponsors and contacts

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