Title
Phenobarbital for Acute Alcohol Withdrawal
Phenobarbital Versus Placebo for Acute Alcohol Withdrawal
Phase
N/ALead Sponsor
Alameda County Medical CenterStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Alcohol WithdrawalIntervention/Treatment
phenobarbital ...Study Participants
102Intravenous phenobarbital in combination with a symptom-guided standardized lorazepam-based alcohol withdrawal protocol will be associated with decreased need for ICU admission, continuous lorazepam infusion and will not be associated with increased adverse events.
10 mg/kg IV phenobarbital in 100 ml saline
100 m l saline
10 mg/kg IV phenobarbital in 100 ml saline
Inclusion Criteria: Need for admission to hospital for acute alcohol withdrawal Exclusion Criteria: allergy to phenobarbital, lorazepam, age<18 or >65
| Event Type | Organ System | Event Term |
|---|
All study patients are placed on the standardized institutional alcohol withdrawal protocol and receive boluses of lorazepam (1, 2 or 4 mg IV) based on their acute alcohol withdrawal score (AAWS), adminstered serially up to every 15 minutes. Patients who are refractory to the maximum dose of lorazepam allowed by the protocol (up to 4mg lorazepam IV q 15 mins)are placed on a continuous IV lorazepam infusion (or "lorazepam drip"). Thus, continuous lorazepam infusion is a "yes or no" variable (i.e. continuous infusion, or not).
admission to intensive care unit
How much total lorazepam did each study patient receive from inital presentation in the Emergency Department through their discharge from the hospital, in milligrams.
hospital LOS, per patient, in hours from admission to discharge
The outome answeres the question "Did the study patient require endotracheal intubation, or not". This outcome investigates if the phenobarbital intervention is associted with increased incidence of respiratory depression and subsequent increased need for intubation.
Did the study patient require a Licensed Vocational Nurse (LVN) or other hospital staff to serve as a "bedside sitter" to observe the patient and provide additional safety supervision during any portion of their hospitalization.
Did the study patient have a witnessed seizure during their hospitaliztion (yes/no).
mortality in study patients
