Status:
COMPLETED
Ketamine for Pain Control After Severe Traumatic Injury
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Hospital Inpatient Trauma Injury
Pain Management
Eligibility:
All Genders
18-64 years
Phase:
NA
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 us...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2025
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT04274361
Start Date
January 20 2021
End Date
February 28 2025
Last Update
March 14 2025
Active Locations (1)
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1
Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226