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Ketamine for Pain Control After Severe Traumatic Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04274361
Recruitment Status : Recruiting
First Posted : February 18, 2020
Last Update Posted : December 16, 2021
Sponsor:
Information provided by (Responsible Party):
Thomas Carver, Medical College of Wisconsin

Brief Summary:
This study evaluates if the early utilization of ketamine infusion therapy among acutely injured adult trauma hospital inpatients with an ISS >15 will decrease the amount of opioid pain medication used as compared with placebo group. Ketamine infusion therapy initiated within 12 hours of hospital arrival will lead to decreased total opiate consumption (standardized to oral morphine equivalent units) in the first 24 and 48 hours compared to controls.

Condition or disease Intervention/treatment Phase
Hospital Inpatient Trauma Injury Pain Management Drug: Ketamine Drug: Placebo Not Applicable

Detailed Description:

Traumatically injured hospital inpatients aged 18 - 64 will be enrolled into the study within 12 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ketamine Infusion for Pain Control in Severe Traumatic Injury: A Randomized Controlled Trial
Actual Study Start Date : January 4, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

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.
Drug: Ketamine
Ketamine infusion

Placebo Comparator: Placebo arm
The 65 patients randomized to the control arm will receive placebo saline solution at a rate equivalent.
Drug: Placebo
Placebo infusion




Primary Outcome Measures :
  1. Cumulative opioid morphine equivalent dose [ Time Frame: The first 24 hours ]
    The cumulative OME will be compared within the two groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-64
  • ISS >15
  • Infusion can be started within 12 hrs of arrival to FMLH (time of injury irrelevant)
  • Admitted to Inpatient hospital trauma service (not Ortho/Plastics/Neurosurgery etc)
  • Not going to OR immediately

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 12 hours of arrival

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04274361


Contacts
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Contact: Margo Mantz-Wichman, BS, RN 414-955-1751 mmantzwichman@mcw.edu
Contact: Amber Brandolino, MS 414-955-1728 abrandolino@mcw.edu

Locations
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United States, Wisconsin
Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Thomas Carver, MD    414-955-1751    Tcarver@mcw.edu   
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
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Principal Investigator: Thomas Carver, MD Medical College of WI
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Thomas Carver, Associate Professor, General Surgery, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT04274361    
Other Study ID Numbers: PRO#00037017
First Posted: February 18, 2020    Key Record Dates
Last Update Posted: December 16, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Wounds and Injuries
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action