Orthopedic Trauma Surgery PatientsPhase 4NCT06903819
Ketamine for Pain, Opioid Use, and Mental Health in Orthopedic Trauma Patients
A Phase 4 study testing Ketamine and standard general anesthesia in people with Orthopedic Trauma Surgery Patients and Postoperative Pain, run by Texas Tech University Health Sciences Center at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Orthopedic Trauma Surgery Patients, Postoperative Pain, Opioid Use
- What is being tested?
- Ketamine and standard general anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Nov 2025to May 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Texas Tech University Health Sciences Center Lubbock
Lubbock, Texas, 79415
Evan J. Hernandez Project Manager, MBA, 806-743-6846, evan.j.hernandez@ttuhsc.edu
Max E. Davis Assistant Professor, MD
- Recruiting
University Medical Center
Lubbock, Texas, 79415
Ami Knox Program Director of Clinical Research, MBA, 806-761-0575, ami.knox@umchealthsystem.com
Max E. Davis Assistant Professor, MD
About this study
Official title: Ketamine's Impact on Opioid Use, Pain, and Mental Health in Polytraumatized Orthopedic Patients: A Randomized Controlled Trial (KOPM)
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:
Read more
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
Read the detailed description
Orthopedic trauma patients often face challenges in both physical and psychological recovery following injury. Pain control is difficult, as effective pain relief must be balanced against the risks of opioid dependence. In addition, rates of depression and post-traumatic stress disorder (PTSD) are high in this population, further complicating recovery. These overlapping challenges highlight the need for new approaches that address both pain and mental health outcomes.
Ketamine, a commonly used anesthetic, has properties that may benefit trauma patients beyond its routine role in surgery. Evidence suggests that low-dose intravenous (IV) ketamine can reduce acute postoperative pain, decrease the need for opioid medications, and have rapid effects on depressive symptoms. Some studies also indicate that ketamine may reduce PTSD-related symptoms by influencing brain pathways involved in stress and memory. However, despite these promising effects, ketamine has not been fully integrated into trauma care protocols, in part due to limited large-scale data in orthopedic populations.
This single-blind randomized controlled trial is designed to evaluate whether a single intraoperative dose of IV ketamine (0.5 mg/kg) improves recovery in adults undergoing surgical fixation for musculoskeletal trauma. Participants will be randomly assigned to receive either ketamine or standard anesthesia without ketamine. While the anesthesia team will be aware of group assignment to ensure patient safety, participants and postoperative care teams will remain blinded.
The study will measure multiple aspects of recovery, including:
Postoperative pain intensity, using a validated Visual Analog Scale (VAS).
Opioid consumption during recovery, quantified from electronic medical records and converted to morphine milligram equivalents (MME).
Psychological outcomes, including symptoms of depression and PTSD, assessed with the PHQ-9 and PCL-5 surveys at defined follow-up intervals.
Follow-up assessments will occur at several time points after surgery, ranging from the early postoperative period (1-7 days) to longer-term recovery (up to 6 months). To accommodate patients unable to attend in-person visits, telehealth-based follow-up is available.
By focusing on both physical and psychological outcomes, this trial aims to determine whether ketamine can serve as a dual-purpose intervention in orthopedic trauma care. Results will provide evidence on the feasibility and potential benefits of incorporating ketamine into standard surgical practice for patients with severe musculoskeletal injuries.
- Conditions
- Orthopedic Trauma Surgery Patients, Postoperative Pain, Opioid Use, Depression, Post-traumatic Stress Disorder (PTSD)
- Being tested
- Ketamine, standard general anesthesia
- Keywords
- Ketamine, Orthopedic Trauma, Postoperative Pain, Opioid Reduction, Depression, PTSD, Musculoskeletal Injury, Trauma Surgery
- Medical subject headings
- Pain, Postoperative, Depression, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
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 anesthesiaDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine Group | Experimental | Participants in this group will receive a single intraoperative dose of intravenous (IV) ketamine (0.5 mg/kg) within 30 minutes of anesthesia induction. The intervention is designed to assess ketamine's effects on postoperative pain, opioid use, and symptoms of depression and PTSD in patients undergoing surgical fixation for musculoskeletal trauma. Receives: Drug: Ketamine |
| Control Group | Active comparator | Participants in this group will receive standard general anesthesia without ketamine. This group serves as a comparison to evaluate the effectiveness of ketamine on postoperative pain levels, opioid consumption, and psychological recovery following orthopedic trauma surgery. Receives: Drug: standard general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1-7 days, 2-3 weeks (±1 week), 6 weeks (±2 weeks), 3 months (±3 weeks), and 6 months (±5 weeks) postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start6 Nov 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthopedic Trauma Surgery PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Max Evan Davis, MD, Principal investigator, Texas Tech University Health Sciences Center Department of Orthopaedic Surgery,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903819
- Sponsor's protocol ID
- IRB-FY2025-75
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Only aggregate results will be published or shared in accordance with ethical guidelines.
Publications
Curran C, Hernandez EJ, Hudnall J, Sra J, Davis ME. Effect of intraoperative ketamine on pain, opioid use, and psychological recovery in orthopedic trauma patients (KOPM trial): protocol for a randomized, single-blind trial. Pain Manag. 2026 Jun 6:1-10. doi: 10.1080/17581869.2026.2682470. Online ahead of print.
PubMed 42251276
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine's Impact on Opioid Use, Pain, and Mental Health in Polytraumatized Orthopedic Patients: A Randomized Controlled Trial (KOPM)
- ClinicalTrials.gov ID
- NCT06903819
- Acronym / sponsor ID
- IRB-FY2025-75
- Conditions
- Orthopedic Trauma Surgery Patients, Postoperative Pain, Opioid Use, Depression, Post-traumatic Stress Disorder (PTSD)
- Keywords
- Ketamine, Orthopedic Trauma, Postoperative Pain, Opioid Reduction, Depression, PTSD, Musculoskeletal Injury, Trauma Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Orthopedic trauma patients often face challenges in both physical and psychological recovery following injury. Pain control is difficult, as effective pain relief must be balanced against the risks of opioid dependence. In addition, rates of depression and post-traumatic stress disorder (PTSD) are high in this population, further complicating recovery. These overlapping challenges highlight the need for new approaches that address both pain and mental health outcomes.
Ketamine, a commonly used anesthetic, has properties that may benefit trauma patients beyond its routine role in surgery. Evidence suggests that low-dose intravenous (IV) ketamine can reduce acute postoperative pain, decrease the need for opioid medications, and have rapid effects on depressive symptoms. Some studies also indicate that ketamine may reduce PTSD-related symptoms by influencing brain pathways involved in stress and memory. However, despite these promising effects, ketamine has not been fully integrated into trauma care protocols, in part due to limited large-scale data in orthopedic populations.
This single-blind randomized controlled trial is designed to evaluate whether a single intraoperative dose of IV ketamine (0.5 mg/kg) improves recovery in adults undergoing surgical fixation for musculoskeletal trauma. Participants will be randomly assigned to receive either ketamine or standard anesthesia without ketamine. While the anesthesia team will be aware of group assignment to ensure patient safety, participants and postoperative care teams will remain blinded.
The study will measure multiple aspects of recovery, including:
Postoperative pain intensity, using a validated Visual Analog Scale (VAS).
Opioid consumption during recovery, quantified from electronic medical records and converted to morphine milligram equivalents (MME).
Psychological outcomes, including symptoms of depression and PTSD, assessed with the PHQ-9 and PCL-5 surveys at defined follow-up intervals.
Follow-up assessments will occur at several time points after surgery, ranging from the early postoperative period (1-7 days) to longer-term recovery (up to 6 months). To accommodate patients unable to attend in-person visits, telehealth-based follow-up is available.
By focusing on both physical and psychological outcomes, this trial aims to determine whether ketamine can serve as a dual-purpose intervention in orthopedic trauma care. Results will provide evidence on the feasibility and potential benefits of incorporating ketamine into standard surgical practice for patients with severe musculoskeletal injuries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine Group | Experimental | Drug: KetamineParticipants in this group will receive a single intraoperative dose of intravenous (IV) ketamine (0.5 mg/kg) within 30 minutes of anesthesia induction. The intervention is designed to assess ketamine's effects on postoperative pain, opioid use, and symptoms of depression and PTSD in patients undergoing surgical fixation for musculoskeletal trauma. |
| Control Group | Active comparator | Drug: standard general anesthesiaParticipants in this group will receive standard general anesthesia without ketamine. This group serves as a comparison to evaluate the effectiveness of ketamine on postoperative pain levels, opioid consumption, and psychological recovery following orthopedic trauma surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineParticipants 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). | Drug | Ketamine Group |
| standard general anesthesiaParticipants 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. | Drug | Control Group |
Primary outcome
Pain Intensity (VAS)
Time frame: 1-7 days, 2-3 weeks (±1 week), 6 weeks (±2 weeks), 3 months (±3 weeks), and 6 months (±5 weeks) postoperatively.
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.
1 secondary outcome
Postoperative Opioid Consumption (MME)
Time frame: 1-7 days, 2-3 weeks (±1 week), 6 weeks (±2 weeks), 3 months (±3 weeks), and 6 months (±5 weeks) postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Derived from this study: PubMed 42251276Curran C, Hernandez EJ, Hudnall J, Sra J, Davis ME. Effect of intraoperative ketamine on pain, opioid use, and psychological recovery in orthopedic trauma patients (KOPM trial): protocol for a randomized, single-blind trial. Pain Manag. 2026 Jun 6:1-10. doi: 10.1080/17581869.2026.2682470. Online ahead of print.
- Individual participant dataSharing planned: No. Only aggregate results will be published or shared in accordance with ethical guidelines.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Max Evan Davis, MD principal investigator
Texas Tech University Health Sciences Center Department of Orthopaedic Surgery,
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine and standard general anesthesia in people with Orthopedic Trauma Surgery Patients and Postoperative Pain, run by Texas Tech University Health Sciences Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evan J Hernandez, MBA (8067436846, evan.j.hernandez@ttuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (VAS) (time frame: 1-7 days, 2-3 weeks (±1 week), 6 weeks (±2 weeks), 3 months (±3 weeks), and 6 months (±5 weeks) postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06903819, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.