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

Authors

  • Kees J. Kalisvaart MD,

    1. From the *Departments of Geriatric Medicine and Orthopedic Surgery, Medical Center Alkmaar, Alkmaar, the NetherlandsDepartment of Pharmacy, Reinier de Graaf Group, Delft, the NetherlandsDepartment of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, the NetherlandsDepartments of §PsychiatryNeurology, Academic Medical Center, University of Amsterdam, Amsterdam, the NetherlandsFree University of Amsterdam, Amsterdam, the Netherlands.
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  • Jos F. M. De Jonghe PhD,

    1. From the *Departments of Geriatric Medicine and Orthopedic Surgery, Medical Center Alkmaar, Alkmaar, the NetherlandsDepartment of Pharmacy, Reinier de Graaf Group, Delft, the NetherlandsDepartment of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, the NetherlandsDepartments of §PsychiatryNeurology, Academic Medical Center, University of Amsterdam, Amsterdam, the NetherlandsFree University of Amsterdam, Amsterdam, the Netherlands.
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  • Marja J. Bogaards PharmD,

    1. From the *Departments of Geriatric Medicine and Orthopedic Surgery, Medical Center Alkmaar, Alkmaar, the NetherlandsDepartment of Pharmacy, Reinier de Graaf Group, Delft, the NetherlandsDepartment of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, the NetherlandsDepartments of §PsychiatryNeurology, Academic Medical Center, University of Amsterdam, Amsterdam, the NetherlandsFree University of Amsterdam, Amsterdam, the Netherlands.
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  • Ralph Vreeswijk RN, MSc,

    1. From the *Departments of Geriatric Medicine and Orthopedic Surgery, Medical Center Alkmaar, Alkmaar, the NetherlandsDepartment of Pharmacy, Reinier de Graaf Group, Delft, the NetherlandsDepartment of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, the NetherlandsDepartments of §PsychiatryNeurology, Academic Medical Center, University of Amsterdam, Amsterdam, the NetherlandsFree University of Amsterdam, Amsterdam, the Netherlands.
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  • Toine C. G. Egberts PhD,

    1. From the *Departments of Geriatric Medicine and Orthopedic Surgery, Medical Center Alkmaar, Alkmaar, the NetherlandsDepartment of Pharmacy, Reinier de Graaf Group, Delft, the NetherlandsDepartment of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, the NetherlandsDepartments of §PsychiatryNeurology, Academic Medical Center, University of Amsterdam, Amsterdam, the NetherlandsFree University of Amsterdam, Amsterdam, the Netherlands.
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  • Bart J. Burger MD, PhD,

    1. From the *Departments of Geriatric Medicine and Orthopedic Surgery, Medical Center Alkmaar, Alkmaar, the NetherlandsDepartment of Pharmacy, Reinier de Graaf Group, Delft, the NetherlandsDepartment of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, the NetherlandsDepartments of §PsychiatryNeurology, Academic Medical Center, University of Amsterdam, Amsterdam, the NetherlandsFree University of Amsterdam, Amsterdam, the Netherlands.
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  • Piet Eikelenboom MD, PhD,

    1. From the *Departments of Geriatric Medicine and Orthopedic Surgery, Medical Center Alkmaar, Alkmaar, the NetherlandsDepartment of Pharmacy, Reinier de Graaf Group, Delft, the NetherlandsDepartment of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, the NetherlandsDepartments of §PsychiatryNeurology, Academic Medical Center, University of Amsterdam, Amsterdam, the NetherlandsFree University of Amsterdam, Amsterdam, the Netherlands.
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  • Willem A. Van Gool MD, PhD

    1. From the *Departments of Geriatric Medicine and Orthopedic Surgery, Medical Center Alkmaar, Alkmaar, the NetherlandsDepartment of Pharmacy, Reinier de Graaf Group, Delft, the NetherlandsDepartment of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, the NetherlandsDepartments of §PsychiatryNeurology, Academic Medical Center, University of Amsterdam, Amsterdam, the NetherlandsFree University of Amsterdam, Amsterdam, the Netherlands.
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  • A paper with the preliminary results was accepted for presentation at the meeting of the American Geriatrics Society in Baltimore, Maryland, 2003. Because of illness, no presentation was made. Abstract was published in the Journal of the American Geriatrics Society, May 2003.

Address correspondence to K. J. Kalisvaart, MD, Medical Center Alkmaar, PO Box 501, 1800 AM Alkmaar, the Netherlands. E-mail: k.kalisvaart@mca.nl

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.

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