Ketamine challenged as safe option for severe brain injury in tiny new study
NCT ID NCT06062628
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase study is testing whether a single dose of ketamine is safe for people with severe traumatic brain injury. Researchers will measure changes in brain pressure and oxygen levels in 10 critically ill adults. The goal is to see if ketamine, which has sedative and pain-relieving properties, can be used without causing harm.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ketamine
- What this could lead to
- If successful, this could show that ketamine is safe for severe TBI patients and may help guide better sedation practices.
- What could go wrong
- This is a very small, early-phase pilot study with only 10 participants, so results may not apply broadly. Ketamine has long been thought to raise brain pressure, and this risk is still being investigated.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Severe traumatic brain injury * Placement of intracranial monitor for measurement of intracranial pressure and brain tissue oxygenation * Age greater than or equal to 18 years Exclusion Criteria: * Documented allergy to ketamine * Sinus tachycardia with sustained heart rate \>120 * Any episode of non-sinus tachycardia * Documented history of schizophrenia * Systolic blood pressure \> 180, diastolic blood pressure \> 120 * Documented episode(s) of ICP elevations \>25 mm Hg sustained greater than 5 minutes within 24 hours * Similar episodes as above of PbtO2 \<15 mmHg * Positive pregnancy test and/or is currently breast-feeding
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Parkland Memorial Hospital
RECRUITINGDallas, Texas, 75235, United States
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Parkland Memorial Hospital
RECRUITINGDallas, Texas, 75235, United States
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Other studies related to the condition(s) this trial covers.
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- Machine learning may forecast brain decline after head injury
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