Intravenous 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
102
10 mg/kg IV phenobarbital in 100 ml saline
100 m l saline
Alameda County Medical Center
Oakland, California, United States
Number of Patients Requiring Continuous Lorazepam Infusion
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).
Time frame: 1 year
Percentage of Patients Requiring ICU Admission
admission to intensive care unit
Time frame: 1 year
Total Lorazepam Required Per Patient Per Admission
How much total lorazepam did each study patient receive from inital presentation in the Emergency Department through their discharge from the hospital, in milligrams.
Time frame: 1 year
Length of Stay
hospital LOS, per patient, in hours from admission to discharge
Time frame: 1 year
Number of Patients Requiring Endotracheal Intubation as a Measure of Safety and Tolerability
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.
Time frame: 1 year
Percentage of Patients Requiring a Bedside Sitter as a Measure of Safety and Tolerability
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.
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Time frame: 1 year
Number of Study Patients With Seizure as a Measure of Safety and Tolerability
Did the study patient have a witnessed seizure during their hospitaliztion (yes/no).
Time frame: 1 year
Number of Study Patients With Mortality as a Measure of Safety and Tolerability
mortality in study patients
Time frame: 1 year