Abstract
BackgroundBenzodiazepines are considered first-line treatment for patients experiencing severe acute alcohol withdrawal syndrome (sAAWS). Although several medications have been evaluated as potential adjuvant treatments for sAAWS, barbiturates show particular promise.ObjectiveIn the PHENOMANAL trial, we will assess the feasibility of conducting an allocation-concealed, quadruple-blinded, randomized controlled trial (RCT) comparing symptom-triggered benzodiazepine therapy with either a single dose of adjuvant intravenous (IV) phenobarbital (7.5 mg/kg of ideal body weight) or a single dose of matching IV placebo for patients with sAAWS.MethodsWe will recruit adult patients from the Emergency Department, Intensive Care Unit, or hospital wards with a Clinical Institute of Withdrawal – Adult revised (CIWA-Ar) score of 16 or more after receipt of at least 60 mg of diazepam or equivalent within 16 h of diagnosis of sAAWS, and an anticipated need for hospitalization. We will randomize participants (n=39) in a 2:1 manner to treatment and placebo groups, respectively. The primary objective of the PHENOMANAL pilot trial will be to demonstrate our ability to recruit the desired population over the trial period. As secondary objectives, we will evaluate clinician compliance with the treatment protocols, assess crossover rates from the placebo arm to the treatment arm, and obtain preliminary estimates of treatment effect. All trial participants will be followed for 7 days or until hospital discharge.RelevanceThe PHENOMANAL trial is novel in investigating a new treatment for a common and understudied condition, repurposing an existing medication for a novel indication, and addressing an important evidence gap. Through conduct of the multidisciplinary pilot trial, we aim to advance methodology in acute care research through the use of a hybrid consent model and inform the design of a large-scale trial.Trial registrationClinicalTrials.gov Registration NCT03586089; first registered July 13, 2018.
Highlights
20,000 Canadians are hospitalized each year for alcohol-related conditions at a cost of 150 million CAD/year [1]
Several medications have been evaluated as potential adjuvant treatments for severe acute alcohol withdrawal syndrome (sAAWS) in meta-analyses [8,9,10,11], barbiturates have been highlighted as a promising treatment in four clinical practice guidelines [12,13,14,15] due to their benzodiazepine-sparing effect and excellent safety profile
Multidisciplinary survey of emergency department (ED) physicians, internists, intensivists, and psychiatrists, members of our group found that four medications were commonly used second-line treatments for sAAWS
Summary
20,000 Canadians are hospitalized each year for alcohol-related conditions at a cost of 150 million CAD/year [1]. In a small RCT, Rosenson and coworkers found that a single dose of IV phenobarbital (10 mg/kg), in addition to lorazepam, vs lorazepam alone, significantly decreased the rate of admission to the ICU (25% to 8%) and the need for a lorazepam infusion (31% to 4%), with no increase in complications [16]. This trial was limited to patients presenting to the emergency department (ED) with sAAWS, investigated symptom-triggered lorazepam treatment (not the current standard of care), and only reported on 50% of randomized participants for various reasons including an inability to obtain first-party consent [16]. Several medications have been evaluated as potential adjuvant treatments for sAAWS, barbiturates show particular promise
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