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Preventing ICU Subsyndromal Delirium Conversion to Delirium With Low-Dose IV Haloperidol: A Double-Blind,
Nada S Al-Qadheeb1, Yoanna Skrobik, Greg Schumaker
11School of Pharmacy, Northeastern University, Boston, MA.2Department of Medicine, McGill University Health Center, Montreal, Quebec, Canada.3Division of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center, Boston, MA.4Department of Psychiatry, Tufts Medical Center, Boston, MA.5Department of Pharmacy, Tufts Medical Center, Boston, MA.6Research Design Center and Biostatistics Research Center, Tufts Clinical and Translational Science Institute, Tufts Medical Center, Boston, MA.
Insights
Low-dose haloperidol did not prevent delirium in critically ill adults with subsyndromal delirium. While it reduced agitation, it offered little therapeutic advantage and showed similar safety outcomes compared to placebo.
Area of Science:
- Critical Care Medicine
- Neuroscience
- Pharmacology
Background:
- Delirium is a common complication in critically ill patients.
- Subsyndromal delirium may precede overt delirium and warrants investigation for preventive strategies.
- Early intervention in intensive care units (ICUs) is crucial for managing patient outcomes.
Purpose of the Study:
- To evaluate the efficacy of scheduled low-dose haloperidol in preventing delirium in critically ill adults with subsyndromal delirium.
- To assess the safety profile of low-dose haloperidol in this patient population.
- To compare haloperidol's impact on agitation and other key ICU outcomes against a placebo.
Main Methods:
- A randomized, double-blind, placebo-controlled trial was conducted in three ICUs.
- Sixty-eight mechanically ventilated patients with subsyndromal delirium were enrolled.
- Patients received either intravenous haloperidol (1 mg every 6 hours) or placebo until delirium, study completion, or ICU discharge.
Main Results:
- Haloperidol did not significantly reduce the incidence of delirium compared to placebo (35% vs. 23%, p = 0.29).
- Haloperidol significantly decreased hours spent agitated (p = 0.008) but did not improve coma-free or delirium-free ICU shifts, time to delirium, or delirium duration.
- Safety outcomes, including QT-interval prolongation, extrapyramidal symptoms, sedation, and hypotension, were comparable between groups.
Conclusions:
- Scheduled low-dose haloperidol initiated early in the ICU does not prevent delirium in mechanically ventilated, critically ill adults with subsyndromal delirium.
- The drug demonstrated a limited therapeutic advantage, primarily by reducing agitation.
- Further research may be needed to explore alternative delirium prevention strategies in this vulnerable patient group.
Objective:
To compare the efficacy and safety of scheduled low-dose haloperidol versus placebo for the prevention of delirium (Intensive Care Delirium Screening Checklist ≥ 4) administered to critically ill adults with subsyndromal delirium (Intensive Care Delirium Screening Checklist = 1-3).
Design:
Randomized, double-blind, placebo-controlled trial.
Setting:
Three 10-bed ICUs (two medical and one surgical) at an academic medical center in the United States.
Patients:
Sixty-eight mechanically ventilated patients with subsyndromal delirium without complicating neurologic conditions, cardiac surgery, or requiring deep sedation.
Interventions:
Patients were randomly assigned to receive IV haloperidol 1 mg or placebo every 6 hours until delirium occurred (Intensive Care Delirium Screening Checklist ≥ 4 with psychiatric confirmation), 10 days of therapy had elapsed, or ICU discharge.
Measurements And Main Results:
Baseline characteristics were similar between the haloperidol (n = 34) and placebo (n = 34) groups. A similar number of patients given haloperidol (12/34 [35%]) and placebo (8/34 [23%]) developed delirium (p = 0.29). Haloperidol use reduced the hours per study day spent agitated (Sedation Agitation Scale ≥ 5) (p = 0.008), but it did not influence the proportion of 12-hour ICU shifts patients spent alive without coma (Sedation Agitation Scale ≤ 2) or delirium (p = 0.36), the time to first delirium occurrence (p = 0.22), nor delirium duration (p = 0.26). Days of mechanical ventilation (p = 0.80), ICU mortality (p = 0.55), and ICU patient disposition (p = 0.22) were similar in the two groups. The proportion of patients who developed corrected QT-interval prolongation (p = 0.16), extrapyramidal symptoms (p = 0.31), excessive sedation (p = 0.31), or new-onset hypotension (p = 1.0) that resulted in study drug discontinuation was comparable between the two groups.
Conclusions:
Low-dose scheduled haloperidol, initiated early in the ICU stay, does not prevent delirium and has little therapeutic advantage in mechanically ventilated, critically ill adults with subsyndromal delirium.
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