Prophylactic haloperidol had no effect on reducing the incidence of delirium, which was diagnosed in 33.3% of haloperidol subjects and 33.0% of placebo patients. Likewise, there were no significant differences between the groups in the number of delirium-free and coma-free days, duration of mechanical ventilation, and ICU and hospital length of stay. The number of reported adverse events with treatment also did not differ significantly between the groups: 0.3% in the 2-mg haloperidol group versus 0.1% in the placebo arm.
The duration of prophylactic therapy was a median of 2 days, but a subgroup analysis in patients treated for more than 2 days also did not show any benefits with haloperidol.
“The study population included severely ill ICU adults whose brains may have been too seriously affected for haloperidol to exert a prophylactic effect, since in non-ICU adults, prophylactic haloperidol may have beneficial effects. But the subgroup of patients with a low severity of illness score also demonstrated no beneficial effects,” the investigators said.
Subjects were a mean of 66.6 years old; 61.4% were men. Most of the ICU admissions were urgent and for medical or surgical reasons.
This study was supported by ZonMw, the Netherlands Organization for Health Research and Development. Dr. van den Boogaard had no disclosures. One author reported grants and consultant and speaker fees from Pfizer, Merck, Astellas, and Gilead, among others.
SOURCE: van den Boogaard M, et al.