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NOT YET RECRUITING
NCT07548489
PHASE3

Phenobarbital for Agitated Delirium

Sponsor: Duke University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-06

Completion Date

2027-07

Last Updated

2026-04-23

Healthy Volunteers

No

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.

Locations (1)

Duke Regional Hospital

Durham, North Carolina, United States