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
Inclusion Criteria2
- Equals or greater than 18 years old
- Admitted to the ICU and has Alcohol Withdrawal Syndrome requiring treatment; determined as having received greater than 20 mg of diazepam, or diazepam equivalents, within a 6-hour period or greater than 40 mg of diazepam within a 24-hour period.
Exclusion Criteria16
- Greater than 75 years old
- Pregnant or breast feeding
- A cause other than alcohol withdrawal is thought to be more likely for delirium
- Admission with polypharmacy overdose and substantial co-ingestion of a CNS depressant drugs (opioids, benzodiazepines, quetiapine or gamma-hydroxy-butyrate) is documented.
- Taking phenobarbital prior to admission
- Known allergy or hypersensitivity syndrome to phenobarbital, primidone, or carbamazepine
- Allergy or rash with other antiepileptics
- On existing evidence is highly likely to discharge against medical advice or die in the next 24 hours
- Goals of care are B2 or less (i.e., not for tracheal intubation)
- Inability to obtain intravenous access
- Acute Kidney Injury Stage 3
- Phenobarbital contraindicated for patient due to local product information
- o Current treatment with drug known to interact with phenobarbital, i.e., ticagrelor, prasugrel, warfarin, a direct oral anticoagulant, enteral/parenteral calcineurin inhibitor, or HIV-protease inhibitor.
- o History of porphyria
- o History of myasthenia gravis
- o Decompensated liver cirrhosis or severe liver disease (determined by an INR greater than 5.0 due to underlying liver disease).
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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