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Dexmedetomidine for the Treatment of Hyperactive Delirium Refractory to Haloperidol in Nonintubated ICU Patients: A Nonrandomized Controlled Trial*

Carrasco, Genís PhD, MD; Baeza, Nacho MD; Cabré, Lluís PhD, MD; Portillo, Eugenia RN; Gimeno, Gemma RN; Manzanedo, David RN; Calizaya, Milagros MD

doi: 10.1097/CCM.0000000000001622
Clinical Investigations

Objectives: To evaluate the clinical effectiveness, safety, and cost of dexmedetomidine for the treatment of agitated delirium refractory to haloperidol in nonintubated critically ill patients.

Design: Nonrandomized, controlled trial.

Setting: Intensive care department of a tertiary care nonprofit hospital.

Patients: All consecutive admissions to a medical-surgical ICU with a diagnosis of agitated delirium.

Interventions: Initial haloperidol titration: all patients received IV bolus doses of haloperidol until agitation was controlled (Richmond Agitation Sedation Scale scoring range, 0 to −2) or reaching the maximum daily dose. Group comparison: patient responders to haloperidol (control group) were compared with nonresponders (dexmedetomidine group).

Measurements and Main Results: A total of 132 nonintubated patients were treated with haloperidol in the initial haloperidol titration phase. Forty-six patients (34.8%; 95% CI, 26.0–43.1%) did not respond to haloperidol, and 86 patients (65.2%; 95% CI, 56.3–73.0%) were responders. During the group comparison phase, dexmedetomidine achieved a higher percentage of time in satisfactory sedation levels than did haloperidol (92.7% [95% CI, 84.5–99.8%] vs 59.3% [95% CI, 48.6–69.3%], respectively; p = 0.0001). Haloperidol was associated with 10 cases (11.6% [95% CI, 6.5–21.2%]) of oversedation and two (2.0% [0.4–8%]) of corrected QT lengthening. Direct cost of dexmedetomidine was 17 times greater than haloperidol, but it achieved a mean savings of $4,370 per patient due to the reduction in length of ICU stay.

Conclusions: In the study conditions, dexmedetomidine shows to be useful as a rescue drug for treating agitation due to delirium in nonintubated patients in whom haloperidol has failed, and it seems to have a better effectiveness, safety, and cost-benefit profile than does haloperidol.

All authors: Department of Intensive Care Medicine, SCIAS Hospital de Barcelona, Barcelona, Spain.

*See also p. 1426.

All authors contributed to the conception and design of this article. Dr. Carrasco contributed to analysis. All authors contributed to interpretation of results. Drs. Carrasco, Baeza, and Cabré contributed to drafting and final version of the article. Dr. Calizaya contributed to critical revisions of the article. Mrs. Portillo and Gimeno and Mr. Manzanedo contributed to data collection.

This study protocol complies with the standards of Transparent Reporting of Evaluations with Nonrandomized Designs (21). This implies that nonrandomized trials should follow the remaining methodological tools employed in randomized trials and the uncertainty introduced by the allocation mechanism should be explicitly reported and, if possible, quantified.

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Supported, in part, by own funds of Intensive Care Service. External funding was not available.

The authors have disclosed that they do not have any potential conflicts of interest.

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