Results All 1789 randomized patients (mean, age years [SD, ]; 1099 men [%]) completed the study. The 1-mg haloperidol group was prematurely stopped because of futility. There was no difference in the median days patients survived in 28 days, 28 days in the 2-mg haloperidol group vs 28 days in the placebo group, for a difference of 0 days (95% CI, 0-0; P = .93) and a hazard ratio of (95% CI, -, P =.82). All of the 15 secondary outcomes were not statistically different. These included delirium incidence (mean difference, %, 95% CI, −% to %), delirium-free and coma-free days (mean difference, 0 days, 95% CI, 0-0 days), and duration of mechanical ventilation, ICU, and hospital length of stay (mean difference, 0 days, 95% CI, 0-0 days for all 3 measures). The number of reported adverse effects did not differ between groups (2 [%] for the 2-mg haloperidol group vs 1 [%] for the placebo group).
As with all antipsychotic agents Haloperidol has been associated with persistent dyskinesias. Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may appear in some patients on long-term therapy or may occur after drug therapy has been discontinued. The risk appears to be greater in elderly patients on high-dose therapy, especially females. The symptoms are persistent and in some patients appear irreversible. The syndrome is characterized by rhythmical involuntary movements of tongue, face, mouth or jaw (., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements). Sometimes these may be accompanied by involuntary movements of extremities and the trunk.
Haldol is available in sterile vials containing 5 mg strength Haldol per 1 ml of fluid used for injection. Usual starting dose is -5 mg intramuscularly. Dose may vary according to patient response to the drug. Switch to an oral form of this drug is recommended as soon as possible. Haldol may interact with other drugs so the patient needs close observation or monitoring to determine if other side effects develop. Haldol should only be used during pregnancy or in women likely to become pregnant only if the benefit clearly justifies a potential risk to the fetus; fetal abnormalities and fetal exposure to Haldol in the third trimester have shown dependence at birth. Women who are breastfeeding should not take Haldol because the drug may affect the infant. Although reports of use for behavior modification exist, the drug is not approved for use in children.