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NCT Number: NCT07548489

Phenobarbital for Agitated Delirium

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.

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Key information

Conditions

Agitated Delirium Confusion Delirium Confusional State Delirium in the Intensive Care Unit Hyperactive Delirium Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Duke Regional Hospital

Durham, North Carolina, 27704, United States

Location contact

Keith W Van Dusen, M.D.

CONTACT

(919) 684-8111

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult Patients identified by providers to have agitated or hyperactive delirium

Exclusion criteria

  • Pregnancy
  • Incarceration
  • Severe liver disease
  • Allergy or prior adverse reaction to phenobarbital or antipsychotic drugs (depending on the month of therapy initiation)

Treatment and study plan

Phenobarbital

Drug

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

Conventional therapy group

Drug

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

Primary outcomes

  1. Provider Compliance

    Time frame: Six months

    The primary outcome of this study will be provider compliance with the study protocol assessed by selection of Conventional or Phenobarbital Therapy according to the designated month.

Secondary outcomes

  1. Hospital Length of Stay

    Time frame: Six months

    Hospital length of stay will be compared between patients receiving Phenobarbital and Conventional therapies.

  2. ICU Length of Stay

    Time frame: Six months

    ICU length of stay will be compared between patients receiving Phenobarbital and Conventional therapies.

  3. Need for rescue medications

    Time frame: Six months

    Need for additional medications above the Phenobarbital or Conventional therapy regimens will be assessed to determine if patients receiving phenobarbital require fewer doses of additional medications.

Study contacts

Contact information is provided by the study sponsor or research team.

Keith W Van Dusen, M.D.

CONTACT

[email protected]

(919) 684-8111

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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