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RecruitingPhase 4

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

NCT06903819 · Texas Tech University Health Sciences Center

Recruiting
Status
Accepting participants
Phase 4
Phase
90
Target enrolment
2
Study sites
1 US states

What it is testing

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

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Pain Intensity (VAS)

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

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

2 study sites

FacilityCityRegionCountry
Texas Tech University Health Sciences Center LubbockLubbockTexasUnited States
University Medical CenterLubbockTexasUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06903819 on ClinicalTrials.gov →

Last updated in the registry 2026-03-24. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits