Phenobarbital for Agitated Delirium
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Keith W. Van Dusen, M.D.
Principal Investigator
Duke University
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either phenobarbital or conventional antipsychotic-based therapy for agitated delirium
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Phenobarbital
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
In alternating months, patients starting therapy for agitated delirium will be assigned to either a phenobarbital regimen or a conventional antipsychotic-based regimen. Patients assigned to Phenobarbital Therapy will receive this drug according to a validated protocol similar to that in use for patients with alcohol withdrawal. Additional "rescue" medications including dexmedetomidine will be available as needed.
In alternating months, patients starting therapy for agitated delirium will be assigned to either a phenobarbital regimen or a conventional antipsychotic-based regimen. Patients assigned to Conventional Therapy will receive antipsychotics as the primary medications for managing their agitation. Additional "rescue" medications including antipsychotics and dexmedetomidine will be available as needed.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
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