- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04274361
Ketamine for Pain Control After Severe Traumatic Injury
Ketamine Infusion for Pain Control in Severe Traumatic Injury: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Traumatically injured hospital inpatients aged 18 - 64 will be enrolled into the study within 24 hours of admission to the hospital. The patients randomized to the experimental arm will receive early ketamine infusion therapy at a rate of 3 mcg/kg/min. All ketamine infusions will be calculated based on ideal body weight (IBW), unless actual body weight is less than ideal. IBW will be calculated for males as 50kg + 2.3*(number of inches above 5 feet) and for women as 45.5kg + 2.3*(number of inches over 5 feet). The 65 patients randomized to the control arm will receive placebo saline solution at a rate equivalent. Time zero will be defined as the time at which the "ketamine / placebo" infusion is begun. For inclusion in the study, initiation of ketamine / placebo infusions must take place within 12 hours of presentation to Froedtert Memorial Lutheran Hospital (FMLH).
Prior to starting the investigational infusion, a single IV push of 50mcg of fentanyl will be administered to any patient with a numeric pain score between 7-10. This is done to achieve more rapid pain control as poor pain control has been shown to lead to higher rates of chronic pain and PTSD.
Patient controlled analgesia will be provided using either morphine or hydromorphone with an initial starting dose of Morphine (1.5mg bolus, 12 min lockout, no continuous rate) or Hydromorphone (0.2mg, 12 min lockout, no continuous rate). Dose or lockout adjustments to the PCA should be done only after first adjusting the Investigational Drug dose. For example, if a patient continues to complain of severe pain (≥6) after 2-4 hours of initiation of the Investigational Drug then the rate of the infusion should be increased (as described below). The adjustments can be initiated by either the RAAPS team or Trauma service. No more than 1 change to PCA or Investigational Drug rate should be performed every 4 hours (ie if PCA was adjusted at midnight, then an adjustment to the Investigational Drug should not be made before 4 am).
At the completion of the 48-hour infusion the inpatient team has the option of transitioning the patient from the PCA to oral pain medications. Additional adjuncts to pain control including epidural or other regional techniques are at the discretion of the primary team but ideally would be delayed until the investigational infusion is completed.
Ketamine infusions will be prepared by the IDS service but will be hung and administered by the inpatient nursing staff. Ketamine infusion therapy will be continued for 48 hours. At 2-4 hours post-infusion the patient's pain will be reassessed. If the NPS is more than 5 the infusion will be increased to 5mcg/kg/min. Following each change in the infusion rate the patient's pain will be reassessed at 2-4 hours and adjustments made accordingly. Maximum infusion rate will be set at 9mcg/kg/min. Conversely, The RAAPS team should be notified if neurologic symptoms (hallucinations, delusions, disturbing dreams, vertigo) are developing and, at the discretion of the RAAPS service, a single dose of lorazepam or midazolam may be utilized. The infusion can be decreased from in 2 mcg/kg/min increments if there are symptoms believed to be related to the infusion that do not respond to benzodiazepines.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Margo Mantz-Wichman, BS, RN
- Phone Number: 414-955-1751
- Email: mmantzwichman@mcw.edu
Study Locations
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Recruiting
- Froedtert Hospital
-
Contact:
- Thomas Carver, MD
- Phone Number: 414-955-1751
- Email: Tcarver@mcw.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18-64
- ISS >15
- Infusion can be started within 24 hrs of arrival to FMLH (time of injury irrelevant)
- Admitted to Inpatient hospital trauma service (not Ortho/Plastics/Neurosurgery etc)
Exclusion Criteria:
- Age <18 or >64
- History of adverse reaction to ketamine therapy
- Chronic opioid therapy defined as > 3 weeks of >30mg oral morphine equivalents per day
- Current substance abuse with opioids including prescription and/or heroin
- Intubation on arrival or need for urgent intubation on arrival
- GCS <13, significant traumatic brain injury, or suspicion of elevated intracranial pressure resulting in the patient's inability to communicate
- History of psychosis
- Active delirium
- Glaucoma
- Ischemic heart disease defined as active acute coronary syndrome
- Severe, poorly controlled hypertension (SBP >200) on more than two readings
- Aortic Injury requiring HR and BP control
- Concurrent use of monoamine oxidase inhibitors (MAOIs)
- Pregnancy
- Prisoners
- Inability to start investigational drug infusion within 24 hours of arrival
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ketamine arm
Early ketamine infusion therapy at a rate of 3 mcg/kg/min.
All ketamine infusions will be calculated based on ideal body weight (IBW), unless actual body weight is less than ideal.
Ketamine infusion therapy will be continued for 48 hours.
At 2-4 hours post-infusion the patient's pain will be reassessed.
If the NPS is more than 5 the infusion will be increased to 5mcg/kg/min.
Following each change in the infusion rate the patient's pain will be reassessed at 2-4 hours and adjustments made accordingly.
Maximum infusion rate will be set at 9mcg/kg/min.
Conversely, The RAAPS team should be notified if neurologic symptoms (hallucinations, delusions, disturbing dreams, vertigo) are developing and, at the discretion of the RAAPS service, a single dose of lorazepam or midazolam may be utilized.
The infusion can be decreased from in 2 mcg/kg/min increments if there are symptoms believed to be related to the infusion that do not respond to benzodiazepines.
|
Ketamine infusion
|
Placebo Comparator: Placebo arm
The 65 patients randomized to the control arm will receive placebo saline solution at a rate equivalent.
|
Placebo infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative opioid morphine equivalent dose
Time Frame: The first 24 hours
|
The cumulative OME will be compared within the two groups.
|
The first 24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thomas Carver, MD, Medical College of WI
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Wounds and Injuries
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID Numbers
- PRO#00037017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain Management
-
Assiut UniversityNot yet recruitingPain Management | Neonates Pain Management
-
Wolfson Medical CenterUnknownPain Management | Post Surgical Management | Inflamation ManagementIsrael
-
Sintetica SACross S.A.CompletedPhase 1: Pain Management | Phase 2: Pain ManagementSwitzerland
-
Värmland County Council, SwedenSykehuset Telemark; Örebro University, Sweden; Dalarna County Council, Sweden; Region... and other collaboratorsCompletedInfant Pain Management | Parent-driven Pain ManagementSweden
-
Cedars-Sinai Medical CenterCompletedImmersive Virtual Reality Intervention for Non-Opioid Pain Management: A Randomized Controlled TrialPain | Pain ManagementUnited States
-
VA Office of Research and DevelopmentCompleted
-
Trakya UniversityCompletedPain | Pain Management | Fear of Pain | Patient EducationTurkey
-
Uludag UniversityRecruiting
-
The University of Texas Health Science Center at...Recruiting
-
Carilion ClinicChorda Pharma, Inc.Completed
Clinical Trials on Ketamine
-
Grace Lim, MD, MSNational Institute of Mental Health (NIMH)RecruitingPain, Postoperative | Depression, PostpartumUnited States
-
Ullevaal University HospitalUniversity of OsloCompleted
-
Assistance Publique - Hôpitaux de ParisCompletedArthroplasty, Replacement, HipFrance
-
Assiut UniversityCompletedKetamine Causing Adverse Effects in Therapeutic UseEgypt
-
Lawson Health Research InstituteUnknownBone Fractures | Dislocations
-
The University of Texas Health Science Center,...TerminatedPost Partum DepressionUnited States
-
Lotus Clinical Research, LLCiX Biopharma Ltd.Completed
-
Eye & ENT Hospital of Fudan UniversityCompletedPain, Procedural | Emotions | Separation AnxietyChina
-
Antonios LikourezosCompleted