Objective: To examine Haloperidol prophylaxis compared to placebo for post-operative delirium in elderly hip-surgery patients.
Design: Prospective, double-blind, placebo-controlled study.
Materials and Methods: Included patients were 70 years of age or older and met the Inouye criteria of medium or high risk of developing post-operative delirium. Risk factors were illness severity (APACHE-II), poor vision (Snellen vision test), cognitive disturbances (MMSE), and dehydration (Ureum-Createnine ratio). Patients (n=442) were randomized to placebo or Haloperidol (1.5 mg/day for 5 days, starting on the day of surgery or maximally two days before). Proactive geriatric consultation was provided to all. Primary endpoint was post-operative delirium. Secondary endpoints were delirium duration, severity of delirium and length of hospital stay. Outcome measures were the CAM, DRS, MMSE and Barnes Akathesia Scale. Daily assessments included whether patients met DSM-IV delirium criteria. Patients who did were discontinued per protocol and received regular medical treatment.
Results: Per protocol analysis entailed 408 patients. Prevalence of delirium was 13.5% (n=55), implying a decrease compared to pre trial data (40%). No effect was noted on the primary endpoint measure of post-operative delirium (23 patients on Haloperidol vs. 32 on placebo). Secondary outcome measures did show a significant effect. Delirium duration was less in the Haloperidol group compared to placebo; 4.4 days, SD 3.5 and 12.0 days, SD 7.5, respectively (T=5.0, df: 46,6, p<0.001). Delirium was also less severe compared to placebo; maximum DRS score 13.6, SD 2.8 vs. 18.2, SD 4.9 resp., (Mann-Whitney U: 152.0, Z=-3.7, p<0.001). Length of hospital stay was shorter in the Haloperidol group compared to placebo; 14.8 days, SD 10.3 vs. placebo 23 days, SD 13.2, (t-test = 2.46, df: 52, p=0.017). No Haloperidol side effects were noted.
Conclusion: Low dose Haloperidol prophylaxis was not associated with a significant reduction of post-operative delirium in elderly hip-fracture patients. However, it did significantly reduce delirium duration, delirium severity, and length of hospital stay.
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