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October 26, 2022

Haloperidol for the Treatment of Delirium in ICU Patients

Mazen Kherallah

Summarized by: 

What was the research question?

  • In patients with delirium, does haloperidol improve outcomes compared to placebo?

How did they do it?

  • A multicenter, blinded, placebo-controlled trial at 18 general ICUs in Denmark, Finland, the United Kingdom, Italy, and Spain.

  • 1000 patients with delirium were randomized to receive 2.5 mg 3 times daily plus 2.5 mg as needed up to 20 mg (510 patients) or placebo (490 patients).

  • The primary outcome was the number of days alive and out of the hospital at 90 days after randomization.

What did they find?

  • The mean number of days alive and out of the hospital at day 90 was not significantly different between the haloperidol group and the placebo group (35.8 vs. 32.9 days, adjusted mean difference of 2.9 days; 95% CI: −1.2 to 7.0, P=0.22).

  • Mortality at 90 days was lower in the haloperidol group compared to the placebo group but not statistically different (36.3% vs 43.3%, adjusted absolute difference, −6.9% [95% CI, −13.0 to −0.6]).

  • Serious adverse reactions occurred in 11 patients in the haloperidol group and in 9 patients in the placebo group.

Were there any limitations?

  • Limited generalizability due to a low number of patients from international sites.

  • The interpretation of the results of the study may have been challenged by the composite nature of the primary outcome.

  • Sparse data on existing conditions other than risk factors for delirium, and no data on other sedatives, pain medications, or nonpharmacologic interventions administered to patients.

What does it mean?

  • Compared to placebo, haloperidol had no significant effect on the number of days alive and out of the hospital at 90 days for ICU patients with delirium.

  • In patients with hyperactive delirium that is impeding management to the point of endangering their care (e.g., may remove lines or tubes), haloperidol could be used to help manage them safely.


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