Phenobarbital in combination benzodiazepine administration compared to benzodiazepine-only Treatment (usual care) for Alcohol Withdrawal Syndrome in the Intensive Care Unit
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 single centre, three-arm, parallel group, electronic medical records embedded and randomised, feasibility trial
The Royal Melbourne Hospital
45 participants
Aug 1, 2025
Interventional
Conditions
Summary
The aim of this study is to determine whether it is feasible within an electronic medical record platform to screen, randomise, and direct the administration of intravenous phenobarbital, as an alternative to usual care, As well as the effect of phenobarbital administration in critically ill patients who are withdrawing from alcohol and are admitted to the Intensive Care Unit. We believe it is feasible to use an electronic medical record platform to guide this study intervention and that, based on current literature, phenobarbital is more effective than current usual care in the setting of alcohol withdrawal requiring ICU admission.
Eligibility
Plain Language Summary
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Interventions
ARM 1. Intravenous infusion Phenobarbital low-dose (4 mg/kg ideal body weight) over 30 minutes + usual care. Thirty minutes after the initial phenobarbital administration, up to two additional intravenous infusion of 2 mg/kg (ideal body weight) can be administered as required in a 48-hour period. Phenobarbital administration will be limited to a 48-hour period of administration. ARM 2. Intravenous infusion Phenobarbital standard-dose (8 mg/kg ideal body weight) over 30 minutes + usual care. Thirty minutes after the initial phenobarbital administration, up to two additional intravenous infusion of 2 mg/kg (ideal body weight) can be administered as required in a 48-hour period. Phenobarbital administration will be limited to a 48-hour period of administration. Adherence to the control will be monitored by confirmation of administration on the electronic medical records system (Epic EMR).
Locations(1)
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ACTRN12625000320459