Haloperidol Prophylaxis for Elderly Hip‐Surgery Patients at Risk for Delirium: A Randomized Placebo‐Controlled Study

Abstract

Objectives: To study the effectiveness of haloperidol prophylaxis on incidence, severity, and duration of postoperative delirium in elderly hip‐surgery patients at risk for delirium. Design: Randomized, double‐blind, placebo‐controlled trial. Setting: Large medical school–affiliated general hospital in Alkmaar, the Netherlands. Participants: A total of 430 hip‐surgery patients aged 70 and older at risk for postoperative delirium. Intervention: Haloperidol 1.5 mg/d or placebo was started preoperatively and continued for up to 3 days postoperatively. Proactive geriatric consultation was provided for all randomized patients. Measurements: The primary outcome was the incidence of postoperative delirium ( Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition , and Confusion Assessment Method criteria). Secondary outcomes were the severity of delirium (Delirium Rating Scale, revised version‐98 (DRS‐R‐98)), the duration of delirium, and the length of hospital stay. Results: The overall incidence of postoperative delirium was 15.8%. The percentage of patients with postoperative delirium in the haloperidol and placebo treatment condition was 15.1% and 16.5%, respectively (relative risk=0.91, 95% confidence interval (CI)=0.6–1.3); the mean highest DRS‐R‐98 score±standard deviation was 14.4±3.4 and 18.4±4.3, respectively (mean difference 4.0, 95% CI=2.0–5.8; P <.001); delirium duration was 5.4 versus 11.8 days, respectively (mean difference 6.4 days, 95% CI=4.0–8.0; P <.001); and the mean number of days in the hospital was 17.1±11.1 and 22.6±16.7, respectively (mean difference 5.5 days, 95% CI=1.4–2.3; P <.001). No haloperidol‐related side effects were noted. Conclusion: Low‐dose haloperidol prophylactic treatment demonstrated no efficacy in reducing the incidence of postoperative delirium. It did have a positive effect on the severity and duration of delirium. Moreover, haloperidol reduced the number of days patients stayed in the hospital, and the therapy was well tolerated.