Haldol Fails to Help ICU Patients with Delirium in New Study

Designed to treat schizophrenia and Tourette syndrome, doctors often use Haldol off-label for the treatment of delirium even though it is not approved for that use.

Doctors often prescribe the antipsychotic Haldol to patients in the Intensive Care Unit (ICU) to help treat delirium. However, the findings of a new study suggest Haldol fails to reduce hospital stays or increase the rate at which patients survive.

Haldol (haloperiodol) is an antipsychotic designed to treat schizophrenia and Tourette Syndrome, among other mental health disorders. Now, new research published last week in the New England Journal of Medicine raises questions about the frequent “off-label” use of Haldol to prevent delirium in ICU patients.

Researchers from New Zealand conducted a multi-center, blinded, placebo-controlled trial involving 1,000 adult patients with delirium. The patients had all been admitted to an ICU for an acute condition. They were randomly assigned to either 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, or they were given a placebo.

According to the findings, 90 days after being admitted to the ICU, there was no significant difference between the average number of days the patients lived or the number of days they spent out of the hospital. The Haldol group had 36 days alive and out of the hospital on average, and the placebo group had 33 days.

The percentage of patients who died by the 90-day mark was 36% in the Haldol group and 43% in the placebo group.

While there was a slight improvement in the Haldol group, researchers said this difference was not significant enough to recommend using Haldol.

“Among patients in the ICU with delirium, treatment with haloperidol did not lead to a significantly greater number of days alive and out of the hospital at 90 days than placebo,” the researchers concluded.

ICU Delirium Risks

A study published earlier this year found that patients in the ICU and on mechanical ventilation who experience delirium often have longer hospital stays. This problem came more to the forefront with the widespread use of mechanical ventilators during the COVID-19 pandemic.

Roughly 30-50% of ICU patients experience delirium, which can lead to increased risk of death and other serious complications.

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In response, many doctors prescribe Haldol to treat this delirium, even though it is not approved for this indication. While drug manufacturers are not allowed to advertise or promote drugs for uses not approved by the U.S. Food and Drug Administration, doctors may prescribe medications for any use they deem necessary.

A prior study published in 2019 found the use of antipsychotics like Haldol failed to offer any benefit to patients when treating or preventing delirium in adult patients. Serious adverse reactions occurred in 11 patients in the Haldol group and nine in the placebo group.

In 2016, research also indicated drugs like Haldol and Risperdal not only failed to reduce symptoms of delirium, but worsened the delirium in patients undergoing palliative care. Patients already experiencing mental side effects, such as delirium, only seemed to fare worse when given Haldol, according to that study’s findings.

Many health experts say instead of giving patients sedatives or other drugs to treat delirium, helping patients get out of bed and get moving, addressing underlying health conditions, and getting family members around the patients and involved are more effective treatments.


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