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Preventing ICU Subsyndromal Delirium Conversion to Delirium With Low-Dose IV Haloperidol: A Double-Blind, Placebo-Controlled Pilot Study.
Crit Care Med 2016; 44(3):583-91CC

Abstract

OBJECTIVE

To compare the efficacy and safety of scheduled low-dose haloperidol versus placebo for the prevention of delirium (Intensive Care Delirium Screening Checklist ≥ 4) administered to critically ill adults with subsyndromal delirium (Intensive Care Delirium Screening Checklist = 1-3).

DESIGN

Randomized, double-blind, placebo-controlled trial.

SETTING

Three 10-bed ICUs (two medical and one surgical) at an academic medical center in the United States.

PATIENTS

Sixty-eight mechanically ventilated patients with subsyndromal delirium without complicating neurologic conditions, cardiac surgery, or requiring deep sedation.

INTERVENTIONS

Patients were randomly assigned to receive IV haloperidol 1 mg or placebo every 6 hours until delirium occurred (Intensive Care Delirium Screening Checklist ≥ 4 with psychiatric confirmation), 10 days of therapy had elapsed, or ICU discharge.

MEASUREMENTS AND MAIN RESULTS

Baseline characteristics were similar between the haloperidol (n = 34) and placebo (n = 34) groups. A similar number of patients given haloperidol (12/34 [35%]) and placebo (8/34 [23%]) developed delirium (p = 0.29). Haloperidol use reduced the hours per study day spent agitated (Sedation Agitation Scale ≥ 5) (p = 0.008), but it did not influence the proportion of 12-hour ICU shifts patients spent alive without coma (Sedation Agitation Scale ≤ 2) or delirium (p = 0.36), the time to first delirium occurrence (p = 0.22), nor delirium duration (p = 0.26). Days of mechanical ventilation (p = 0.80), ICU mortality (p = 0.55), and ICU patient disposition (p = 0.22) were similar in the two groups. The proportion of patients who developed corrected QT-interval prolongation (p = 0.16), extrapyramidal symptoms (p = 0.31), excessive sedation (p = 0.31), or new-onset hypotension (p = 1.0) that resulted in study drug discontinuation was comparable between the two groups.

CONCLUSIONS

Low-dose scheduled haloperidol, initiated early in the ICU stay, does not prevent delirium and has little therapeutic advantage in mechanically ventilated, critically ill adults with subsyndromal delirium.

Authors+Show Affiliations

1School of Pharmacy, Northeastern University, Boston, MA.2Department of Medicine, McGill University Health Center, Montreal, Quebec, Canada.3Division of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center, Boston, MA.4Department of Psychiatry, Tufts Medical Center, Boston, MA.5Department of Pharmacy, Tufts Medical Center, Boston, MA.6Research Design Center and Biostatistics Research Center, Tufts Clinical and Translational Science Institute, Tufts Medical Center, Boston, MA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

26540397

Citation

Al-Qadheeb, Nada S., et al. "Preventing ICU Subsyndromal Delirium Conversion to Delirium With Low-Dose IV Haloperidol: a Double-Blind, Placebo-Controlled Pilot Study." Critical Care Medicine, vol. 44, no. 3, 2016, pp. 583-91.
Al-Qadheeb NS, Skrobik Y, Schumaker G, et al. Preventing ICU Subsyndromal Delirium Conversion to Delirium With Low-Dose IV Haloperidol: A Double-Blind, Placebo-Controlled Pilot Study. Crit Care Med. 2016;44(3):583-91.
Al-Qadheeb, N. S., Skrobik, Y., Schumaker, G., Pacheco, M. N., Roberts, R. J., Ruthazer, R. R., & Devlin, J. W. (2016). Preventing ICU Subsyndromal Delirium Conversion to Delirium With Low-Dose IV Haloperidol: A Double-Blind, Placebo-Controlled Pilot Study. Critical Care Medicine, 44(3), pp. 583-91. doi:10.1097/CCM.0000000000001411.
Al-Qadheeb NS, et al. Preventing ICU Subsyndromal Delirium Conversion to Delirium With Low-Dose IV Haloperidol: a Double-Blind, Placebo-Controlled Pilot Study. Crit Care Med. 2016;44(3):583-91. PubMed PMID: 26540397.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Preventing ICU Subsyndromal Delirium Conversion to Delirium With Low-Dose IV Haloperidol: A Double-Blind, Placebo-Controlled Pilot Study. AU - Al-Qadheeb,Nada S, AU - Skrobik,Yoanna, AU - Schumaker,Greg, AU - Pacheco,Manuel N, AU - Roberts,Russel J, AU - Ruthazer,Robin R, AU - Devlin,John W, PY - 2017/03/01/pmc-release PY - 2015/11/6/entrez PY - 2015/11/6/pubmed PY - 2016/7/13/medline SP - 583 EP - 91 JF - Critical care medicine JO - Crit. Care Med. VL - 44 IS - 3 N2 - OBJECTIVE: To compare the efficacy and safety of scheduled low-dose haloperidol versus placebo for the prevention of delirium (Intensive Care Delirium Screening Checklist ≥ 4) administered to critically ill adults with subsyndromal delirium (Intensive Care Delirium Screening Checklist = 1-3). DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Three 10-bed ICUs (two medical and one surgical) at an academic medical center in the United States. PATIENTS: Sixty-eight mechanically ventilated patients with subsyndromal delirium without complicating neurologic conditions, cardiac surgery, or requiring deep sedation. INTERVENTIONS: Patients were randomly assigned to receive IV haloperidol 1 mg or placebo every 6 hours until delirium occurred (Intensive Care Delirium Screening Checklist ≥ 4 with psychiatric confirmation), 10 days of therapy had elapsed, or ICU discharge. MEASUREMENTS AND MAIN RESULTS: Baseline characteristics were similar between the haloperidol (n = 34) and placebo (n = 34) groups. A similar number of patients given haloperidol (12/34 [35%]) and placebo (8/34 [23%]) developed delirium (p = 0.29). Haloperidol use reduced the hours per study day spent agitated (Sedation Agitation Scale ≥ 5) (p = 0.008), but it did not influence the proportion of 12-hour ICU shifts patients spent alive without coma (Sedation Agitation Scale ≤ 2) or delirium (p = 0.36), the time to first delirium occurrence (p = 0.22), nor delirium duration (p = 0.26). Days of mechanical ventilation (p = 0.80), ICU mortality (p = 0.55), and ICU patient disposition (p = 0.22) were similar in the two groups. The proportion of patients who developed corrected QT-interval prolongation (p = 0.16), extrapyramidal symptoms (p = 0.31), excessive sedation (p = 0.31), or new-onset hypotension (p = 1.0) that resulted in study drug discontinuation was comparable between the two groups. CONCLUSIONS: Low-dose scheduled haloperidol, initiated early in the ICU stay, does not prevent delirium and has little therapeutic advantage in mechanically ventilated, critically ill adults with subsyndromal delirium. SN - 1530-0293 UR - https://www.unboundmedicine.com/medline/citation/26540397/Preventing_ICU_Subsyndromal_Delirium_Conversion_to_Delirium_With_Low_Dose_IV_Haloperidol:_A_Double_Blind_Placebo_Controlled_Pilot_Study_ L2 - http://Insights.ovid.com/pubmed?pmid=26540397 DB - PRIME DP - Unbound Medicine ER -