Table 2 Clinical trials evaluating antipsychotics in critically ill patients with delirium.
Author, year | No. of patients | Inclusion criteria | Interventions | Blinding | Randomization | Primary endpoint | Results |
|---|---|---|---|---|---|---|---|
Reade [84], 2009 | 20 | Mechanical ventilation, inability to extubate because of agitation | Dexmedetomidine 0.2-0.7 mcg/kg/h (loading dose was optional) Haloperidol 0.5-2 mg/h (loading dose was optional) | No | Computer-generated random sequence | Time from commencement of study drug to extubation | Patients on dexmedetomidine were extubated sooner than those on haloperidol: 9.9 (IQR 7.3-24) vs. 42.5 (IQR 23.2-117.8) hours, P = 0.016. |
Girard [85], 2010 | 101 | Mechanical ventilation, abnormal level of consciousness, receipt of sedative or analgesic medications | Haloperidol 5 mg Ziprasidone 40 mg placebo. Second dose administered 12 hours after the first if QT < 500 msec; then every 6 hours. | Yes | Computer-generated, permuted-block randomization scheme | Number of days alive without delirium or coma | No significant difference in number of days alive without delirium or coma. P = 0.66. Haloperidol: 14 (IQR 6–18) days Ziprasidone: 15 (IQR 9.1-18) days Placebo: 12.5 (IQR 1.2-17.2) days |
Devlin [86], 2010 | 36 | ICU patients with delirium and an order for as-needed haloperidol | Quetiapine 50 mg every 12 hours titrated upwards on a daily basis if haloperidol was needed. Placebo. | Yes | Computer-generated random sequence | Time to first resolution of delirium | Time to first resolution was shorter with Quetiapine therapy than with placebo, P = 0.001. Quetiapine: 1 (IQR 0.5-3) days Placebo: 4.5 (IQR 2–7) days |
Skrobik [87], 2004 | 73 | ICU patients with delirium | Haloperidol 2.5-5 mg every 8 hours Olanzapine 5 mg daily | Only those assessing outcomes | Even/odds day basis | Not specified | No difference in delirium index scores, P = 0.83. No difference in benzodiazepine use, P = 0.9. |