Phenobarbital for Acute Alcohol Withdrawal

Study Overview
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Brief Summary
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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.

Official Title
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Phenobarbital Versus Placebo for Acute Alcohol Withdrawal

Conditions
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Alcohol Withdrawal

Intervention / Treatment
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* Drug: 10 mg/kg IV phenobarbital in 100 ml saline
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Need for admission to hospital for acute alcohol withdrawal Exclusion Criteria: allergy to phenobarbital, lorazepam, age<18 or >65

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Phenobarbital group<br>10 mg/kg IV phenobarbital in 100 ml saline | Drug: 10 mg/kg IV phenobarbital in 100 ml saline<br>* 10 mg/kg IV phenobarbital in 100 ml saline<br>|
| Placebo Comparator: Placebo group<br>100 ml saline | Drug: placebo<br>* 100 m l saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 1 year | 
| Percentage of Patients Requiring ICU Admission | admission to intensive care unit | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay | hospital LOS, per patient, in hours from admission to discharge | 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. | 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. | 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). | 1 year | 
| Number of Study Patients With Mortality as a Measure of Safety and Tolerability | mortality in study patients | 1 year |