Phenobarbital ICU Agitated Delirium Phase 3 Trial
Summary
NIH has registered a Phase 3 clinical trial (NCT07548489) to evaluate whether phenobarbital is as effective as conventional therapy for treating agitated delirium in adult intensive care unit patients. The trial will monitor ICU and hospital length of stay as well as the amount of additional calming medications required. Participants will be divided between phenobarbital treatment and conventional therapy groups, with close safety monitoring throughout the study.
“The goal of this clinical trial is to test whether the medication phenobarbital is as effective for treating agitated delirium among adult patients admitted to the intensive care unit.”
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What changed
NIH has registered a new Phase 3 clinical trial (NCT07548489) on ClinicalTrials.gov to study phenobarbital as a treatment for agitated delirium in adult ICU patients. The trial will compare phenobarbital against conventional therapy and measure outcomes including ICU length of stay, hospital stay duration, and additional calming medication requirements. This is an informational registration entry for an ongoing clinical investigation.
Healthcare providers and clinical investigators involved in ICU delirium management may encounter phenobarbital as an alternative intervention under study. Pharmaceutical manufacturers producing phenobarbital or related sedatives should be aware of this trial's focus on ICU delirium applications. No compliance obligations are created by this clinical trial registration.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Phenobarbital for Agitated Delirium
Phase 3 NCT07548489 Kind: PHASE3 Apr 23, 2026
Abstract
The goal of this clinical trial is to test whether the medication phenobarbital is as effective for treating agitated delirium among adult patients admitted to the intensive care unit. Agitated delirium is a condition involving confusion and impulsiveness which is dangerous to both patients and healthcare providers.
The main questions this trial aims to answer include:
- Can phenobarbital decrease the amount of time patients with agitated delirium spend in the intensive care unit and the hospital?
- Does phenobarbital decrease the amount of additional calming medications patients with agitated delirium need?
Researchers in this study will compare phenobarbital to other medications commonly used to treat agitated delirium.
Participants will be monitored closely to make sure they remain safe and to measure how well their agitation and confusion are managed while they are in the ICU.
Conditions: Agitated Delirium, Delirium Confusional State, Delirium in the Intensive Care Unit, Hyperactive Delirium
Interventions: Phenobarbital, Conventional therapy group
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