Does low-dose droperidol administration increase the risk of drug-induced QT prolongation and torsade de pointes in the general surgical population?
| Autor: | Kelly A. Jacob, Michael J. Ackerman, Susan K. Wigersma, Gregory A. Nuttall, Bradly J. Narr, Mary E. Shirk Marienau, Erin M. Pawlaski, William C. Oliver, Karen M. Eckerman |
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| Rok vydání: | 2007 |
| Předmět: |
Risk
Quality Assurance Health Care Population Torsades de pointes Anesthesia General QT interval Electrocardiography Torsades de Pointes medicine Droperidol education Cause of death Retrospective Studies education.field_of_study business.industry United States Food and Drug Administration Incidence (epidemiology) Drug-induced QT prolongation Nerve Block medicine.disease Confidence interval United States Long QT Syndrome Anesthesiology and Pain Medicine Anesthesia Postoperative Nausea and Vomiting Antiemetics business medicine.drug Adjuvants Anesthesia |
| Zdroj: | Anesthesiology. 107(4) |
| ISSN: | 0003-3022 |
| Popis: | Background The US Food and Drug Administration issued a black box warning regarding the use of droperidol and the potential for torsade de pointes (TdP). Methods The primary objective of this retrospective study was to determine whether low-dose droperidol administration increased the incidence of TdP in the general surgical population during a 3-yr time period before and after the Food and Drug Administration black box warning. A random sample of 150 surgical patients during each time interval was selected to estimate the droperidol use for each time period. Results During the time period before the black box warning (July 1, 1998 to June 30, 2001), 2,321/139,932 patients (1.66%) had QT prolongation, TdP, or death within 48 h after surgery. We could identify no patients who clearly developed TdP before the black box warning. There was one patient for whom the cause of death could not positively be ruled out as due to TdP. In the time period after the black box warning (July 1, 2002 to June 30, 2005), 2,207 patients (1.46%) had documented QT prolongation, TdP, or death within 48 h after surgery, including only two cases ( Conclusions This indicates that the Food and Drug Administration black box warning for low dose droperidol is excessive and unnecessary. |
| Databáze: | OpenAIRE |
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