Clinical trial NCT06903819: Ketamine for Pain, Opioid Use, and Mental Health in Orthopedic Trauma Patients
Official title: Ketamine's Impact on Opioid Use, Pain, and Mental Health in Polytraumatized Orthopedic Patients: A Randomized Controlled Trial (KOPM)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
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
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn whether a single dose of ketamine during surgery can help lower pain, reduce the need for opioid medications, and improve mental health recovery in adults with serious orthopedic injuries. The main questions it aims to answer are:

Does ketamine lower pain after surgery? Does ketamine help reduce how much opioid medicine participants need? Does ketamine improve symptoms of depression and post-traumatic stress disorder (PTSD)? Researchers will compare participants who receive ketamine during surgery to those who receive standard anesthesia without ketamine.

Participants will:

Receive either ketamine or standard anesthesia during surgery Answer survey questions about pain, depression, and PTSD at several points after surgery (from a few days up to 6 months) Be followed by the research team through clinic visits and phone calls

Detailed description: This randomized controlled trial will evaluate whether giving a single dose of intravenous (IV) ketamine during surgery can improve postoperative outcomes for adults with severe orthopedic injuries. Participants will be adults aged 18-65 undergoing surgery for musculoskeletal trauma at a Level I trauma center. All eligible participants will have an Injury Severity Score (ISS) greater than 15.

Participants will be randomly assigned to receive either standard general anesthesia or anesthesia with an added dose of IV ketamine (0.5 mg/kg). The study will track pain levels, opioid use, and symptoms of depression and post-traumatic stress disorder (PTSD) using validated surveys and pain rating scales. Outcomes will be measured at multiple points after surgery, including 1-7 days, 2-3 weeks, 3 months, and 6 months.

This study will help determine if ketamine can improve both physical and mental recovery in people with complex orthopedic trauma, and whether it should be considered as part of routine trauma care.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Intensity After Surgery
timeFrame: Measured at 1-7 days, 2-3 weeks, 3 months, and 6 months postoperatively
Secondary outcomes:
measure: Postoperative Opioid Consumption
timeFrame: Measured cumulatively at 1-7 days, 2-3 weeks, 3 months, and 6 months postoperatively
Other outcomes:
measure: Depression Symptoms
timeFrame: Measured at 2-3 weeks, 3 months, and 6 months postoperatively
measure: PTSD Symptoms
timeFrame: Measured at 2-3 weeks, 3 months, and 6 months postoperatively
Locations:
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center Lubbock
state: Texas
city: Lubbock
country: United States
facility: University Medical Center
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center Department of Orthopaedic Surgery,
name: Max E. Davis Assistant Professor, MD
role: PRINCIPAL_INVESTIGATOR
References: