Haloperidol, an antipsychotic drug used in many hospitals to treat delirium in critically ill patients, is no more effective than placebo in reducing the number of days that critically ill patients spend either delirious or in a coma, according to a study.
Although causality between delirium and mortality is not established, critically ill patients who develop delirium are up to three times more likely to die by 6 months than are those who do not. Delirium may also add to the distress and discomfort experienced by critically ill patients and their families.
A group of British researchers led by Valerie Page, MBBCh, tested the effect of haloperidol on delirium in 141 critically ill patients on artificial ventilation in Watford General Hospital in the United Kingdom. For the study, published Aug. 21 on the website of The Lancet Respiratory Medicine, 71 patients received haloperidol to treat delirium and 70 received a placebo.
Haloperidol doses were based on existing clinical practice for the management of delirium, and patients were carefully monitored for adverse reactions to the drug, as well as over-sedation. Both the clinicians administering the study drug and the researchers who analyzed the data were not aware of patients placement in the control or study groups.
The researchers found that compared to the placebo group, haloperidol had no effect on the number of days spent without delirium or without coma, up to 14 days after the study began. Nor did the drug affect mortality rates, length of stay in critical care or the hospital, or number of ventilator-free days up to 28 days after the study began.
Despite its lack of effectiveness in treating delirium, the trial results show that patients given haloperidol seemed to require less sedation than those given placebo, suggesting that the drug may still be useful for short-term management of acute agitation.
“Despite a limited evidence base, increasing numbers of patients are being exposed to haloperidol for the management of delirium,” Page said in a news release. “Our results suggest a commonly used haloperidol dose regimen does not increase delirium in critically ill patients requiring mechanical ventilation, when commenced during early ICU stay.
“Although haloperidol can be used safely in this population of patients, our results do not support the idea that haloperidol modifies duration of delirium in critically ill patients. Identification of a drug to prevent or reduce delirium and improve adverse outcomes, including in the intensive care setting, needs to be a high priority within delirium research.”
In an accompanying commentary, Yoanna Srkobik, MD, FRCP, of the University of Montreal, wrote: “Although haloperidol is used commonly, its use to treat delirium does not seem to be justified.”
Skrobik went on to question whether delirium even needs to be treated with drugs: “Only non-pharmacological prevention measures have been shown to reduce its occurrence in critically ill patients. Non-pharmacological interventions are effective in numerous psychiatric and psychological disturbances. The challenge lies in the distress delirium symptoms cause in caregivers. We should be asking ourselves, are we treating the patients or our own discomfort.”
Study abstract: http://bit.ly/19KpPM7.