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Phenobarbital for Agitated Delirium

NCT07548489 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-04-23

No results posted yet for this study

Summary

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

DRUG

Phenobarbital

Patients assigned to Phenobarbital Therapy will receive a validated regimen of this medication to manage their symptoms of agitation and impulsiveness.

DRUG

Conventional therapy group

Patients assigned to Conventional Therapy will receive antipsychotics as the primary medication class used to manage their agitation and impulsiveness.

Sponsors & Collaborators

Principal Investigators

  • Keith W. Van Dusen, M.D. · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-01-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07548489 on ClinicalTrials.gov