Haloperidol of little benefit to ICU patients with delirium

Treatment with haloperidol falls short of improving survival in intensive care unit (ICU) patients who are experiencing delirium, as shown in a study.

The study included 1,000 patients with delirium who had been admitted to the ICU for an acute condition. They were randomized to receive intravenous haloperidol (2.5 mg three times daily plus 2.5 mg as needed up to a total maximum daily dose of 20 mg; n=510) or placebo (n=490). Treatment was administered in the ICU for as long as delirium continued and as needed for recurrences.

A total of 987 patients (98.7 percent) were included in the final analysis, among whom 501 were in the haloperidol group and 486 in the placebo group. The primary outcome was the number of days alive and out of the hospital at 90 days after randomization, with outcome data available for 963 patients.

There was no significant between-group difference in the mean number of days alive and out of the hospital at 90 days (35.8, 95 percent confidence interval [CI], 32.9–38.6 with haloperidol vs 32.9 (9, 5 percent CI, 29.9–35.8 with placebo; adjusted mean difference, 2.9 days, 95 percent CI, −1.2 to 7.0; p=0.22).

Mortality at 90 days was 36.3 percent with haloperidol and 43.3 percent with placebo (adjusted absolute difference, −6.9 percentage points, 95 percent CI, −13.0 to −0.6). Serious adverse reactions occurred in 11 patients who received haloperidol and in nine who received placebo.