Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2025-12-24 @ 12:04 PM
NCT ID:
NCT04274361
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT04274361
Study Brief:
Protocol Section:
NCT04274361