The goal of this study will aim to determine if adding phenobarbital or ketamine to a symptom-triggered benzodiazepine regimen decreases the rate of intensive care unit admissions during the treatment of alcohol withdrawal syndrome when compared to symptom-triggered benzodiazepine therapy alone.
The primary objective of this study is to compare phenobarbital and ketamine adjunctive therapies to lorazepam-based therapy in the treatment of acute alcohol withdrawal syndrome. It is hypothesized that the use of an alternative agent, either phenobarbital or ketamine, when used as an adjunct to symptom-triggered lorazepam therapy will significantly reduce the rate of intensive care unit admissions and thereby reduce the total cost associated with hospital admission for treatment of alcohol withdrawal syndrome. Enrolled patients will be admitted to Santa Barbara Cottage Hospital where they will be monitored with continuous pulse oximetry and cardiac telemetry. They will remain hospitalized while undergoing study-guided therapy in addition to supportive care for acute alcohol withdrawal syndrome. Patients will undergo standard of care therapy with lorazepam symptom-triggered therapy regardless of study participation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Ketamine infusion
Phenobarbital intravenous injection
Standard of Care
Intensive Care Unit admission rate
Number of admissions to the intensive care unit
Time frame: Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years
Incidence of withdrawal seizures
Number of patients with documented seizures while treated for alcohol withdrawal syndrome
Time frame: Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years
Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) scores
CIWA-Ar scores (initial, maximum, discharge); Total score is cumulative of subscale measures: Minimum score is 0 (no evidence of alcohol withdrawal), Maximum score is 67 (severe alcohol withdrawal) Subscale measures: A) Nausea and vomiting (score 0-7); B) Tremor (score 0-7); C) Paroxysmal sweats (score 0-7); D) Anxiety (score 0-7); E) Tactile disturbances (score 0-7); F) Auditory disturbances (score 0-7); G) Visual disturbances (score 0-7); H) Headache, fullness in head (score 0-7); I) Agitation (score 0-7); J) Orientation and clouding of sensorium (score 0-4)
Time frame: Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years
Cumulative dose of medication/s administered
Cumulative dose of Lorazepam, Ketamine, and Phenobarbital
Time frame: Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years
Incidence of refractory alcohol withdrawal requiring alternative sedation with dexmedetomidine, propofol or midazolam infusions
Number of patients who require Dexmedetomidine, Propofol or Benzodiazepine continuous infusions and average dose while being treated for alcohol withdrawal syndrome
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Placebo injection
Placebo infusion
Time frame: Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years
Rate of mechanical ventilation
Rate of intubation
Time frame: Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years
Incidence of alcohol withdrawal hallucinations
Number of patients with documented auditory or visual hallucinations
Time frame: Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years