CompletedNot Applicable

Ketamine for Pain Control After Severe Traumatic Injury

United States93 participantsStarted 2021-01-20

Plain-language 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.

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cumulative opioid morphine equivalent dose

Timeframe: The first 24 hours

Trial details

NCT IDNCT04274361

SponsorMedical College of Wisconsin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-28

View on ClinicalTrials.gov More Hospital Inpatient Trauma Injury trials