Phenobarbital as an Adjuvant to benzodiazepine administration when compared to Single-agent benzodiazepine Treatment (usual care) for Alcohol Withdrawal Syndrome in the Intensive Care Unit (PASTA): a study protocol for a feasibility trial that embeds screening, enrolment and randomization within the electronic medical records

Background Abrupt cessation of alcohol consumption following hospital admission can induce alcohol withdrawal syndrome. This syndrome is challenging to manage and is associated with considerable morbidity and mortality. Current management of alcohol withdrawal syndrome in Australia is generally titrated benzodiazepine administration. In some regions, phenobarbital is preferred but evidence to support its superiority is weak. Methods: We will conduct a single centre, three-arm, open-label, parallel group, randomized clinical trial. Our primary objective is to determine the feasibility of embedding a randomized clinical trial within an electronic medical record to compare phenobarbital to single-agent benzodiazepine for patients with alcohol withdrawal. We will screen and randomize 45 patients using the Epic electronic medical record system. Patients will receive either low- or standard-dose intravenous phenobarbital (4 or 8 milligrams per kilogram), or usual care (benzodiazepine regimen). The primary outcome is feasibility, determined by useability, screening rates, enrolment rates, and compliance. Secondary outcomes include alcohol withdrawal scale scores, dose of benzodiazepine administered, health utilisation, adjuvant drug treatments, and patient outcomes. Discussion: There are limited high quality data evaluating the use of phenobarbital administration for alcohol withdrawal syndrome. Additionally, there is limited data evaluating the embedding of screening, randomization, and administration of a sedative drug within the electronic medical record. Our feasibility trial will establish whether this is possible within our health care system. In this protocol paper we detail how we will embed this trial within the electronic medical record Epic. Trial registration The study (RMH2024.320 v2 06/01/2025) is registered with Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12625000320459. Registered 17 April 2025, https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=ACTRN12625000320459. Trial Sponsor: The Royal Melbourne Hospital.