Delirium is frequently diagnosed in critically ill patients and is associated with poor clinical outcomes. Haloperidol ( Haldol, Serenase ) is the most commonly used drug for delirium despite little evidence of its effectiveness.
The aim of a study was to establish whether early treatment with Haloperidol would decrease the time that survivors of critical illness spent in delirium or coma.
Researchers did this double-blind, placebo-controlled randomised trial in a general adult intensive care unit ( ICU ). Critically ill patients ( greater than or equal to 18 years ) needing mechanical ventilation within 72 h of admission were enrolled.
Patients were randomised, in 1:1 ratio, to receive Haloperidol 2.5 mg or 0.9% saline placebo intravenously every 8 h, irrespective of coma or delirium status.
Study drug was discontinued on ICU discharge, once delirium-free and coma-free for 2 consecutive days, or after a maximum of 14 days of treatment, whichever came first.
Delirium was assessed using the confusion assessment method for the ICU ( CAM-ICU ).
The primary outcome was delirium-free and coma-free days, defined as the number of days in the first 14 days after randomisation during which the patient was alive without delirium and not in coma from any cause.
Patients who died within the 14 day study period were recorded as having 0 days free of delirium and coma.
ICU clinical and research staff and patients were masked to treatment throughout the study.
Analyses were by intention to treat.
142 patients were randomised, 141 were included in the final analysis ( 71 Haloperidol, 70 placebo ).
Patients in the haloperidol group spent about the same number of days alive, without delirium, and without coma as did patients in the placebo group ( median 5 days vs 6 days days; p=0.53 ).
The most common adverse events were oversedation ( 11 patients in the Haloperidol group vs six in the placebo group ) and QTc prolongation ( 7 patients in the Haloperidol group vs 6 in the placebo group ).
No patient had a serious adverse event related to the study drug.
These results do not support the hypothesis that Haloperidol modifies duration of delirium in critically ill patients.
Although Haloperidol can be used safely in this population of patients, pending the results of trials in progress, the use of intravenous Haloperidol should be reserved for short-term management of acute agitation. ( Xagena )
Page VJ et al, The Lancet Respiratory Medicine 2013; 1; 515-523