Key result
Droperidol administration in the emergency department was associated with an extremely rare incidence of Torsades des Pointes, occurring in only 1 of 16,546 patients (0.006%).
Why the study?
Droperidol carries an FDA boxed warning for QT prolongation and TdP, leading to clinical uncertainty following its reintroduction in the US.
Does parenteral droperidol increase the incidence of QT prolongation and Torsades des Pointes in emergency department patients?
Cohort (n=16,546)
No
Does parenteral droperidol increase the incidence of QT prolongation and Torsades des Pointes in emergency department patients?
The incidence of clinically significant QT prolongation and Torsades des Pointes in ED patients receiving droperidol is extremely rare, suggesting the FDA black box warning may be overstated.
Rare TdP incidence with droperidol in ED supports cautious use; leaves open randomized confirmation versus FDA warning.
INTRODUCTION: Droperidol carries a boxed warning from the United States Food and Drug Administration for QT prolongation and torsades des pointes (TdP). After a six-year hiatus, droperidol again became widely available in the US in early 2019. With its return, clinicians must again make decisions regarding the boxed warning. Thus, the objective of this study was to report the incidence of QT prolongation or TdP in patients receiving droperidol in the ED. METHODS: Patients receiving droperidol at an urban Level I trauma center from 1997-2001 were identified via electronic health record query. All patients were reviewed for cardiac arrest. We reviewed electrocardiogram (ECG) data for both critically-ill and noncritical patients and recorded Bazett's corrected QT intervals (QTc). ECGs from critically-ill patients undergoing resuscitation were further risk-stratified using the QT nomogram. RESULTS: Of noncritical patients, 15,374 received 18,020 doses of droperidol; 2,431 had an ECG. In patients with ECGs before and after droperidol, the mean QTc was 424.3 milliseconds (ms) (95% confidence interval [CI], 419.7-428.9) before and 427.6 ms (95% CI, 424.3-430.9), after droperidol (n = 170). Regarding critically-ill patients, 1,172 received droperidol and 396 had an ECG. In the critically-ill group with ECGs before and after droperidol mean QTc was 435.7 ms (95% CI, 426.7-444.7) before and 435.8 ms (95% CI, 427.5-444.1) after droperidol (n = 114). Of 337 ECGs suitable for plotting on the QT nomogram, 13 (3.8%) were above the "at-risk" line; 3/136 (2.2%; 95% CI, 0.05-6.3%) in the before group, and 10/202 (4.9%; 95% CI, 2.4%-8.9%) in the after group. A single case of TdP occurred in a patient with multiple risk factors that did not reoccur after a droperidol rechallenge. Thus, the incidence of TdP was 1/16,546 (0.006%; 95% CI, 0.00015 - 0.03367%). CONCLUSION: We found the incidence of QTc prolongation and TdP in ED patients receiving droperidol to be extremely rare. Our data suggest the FDA "black box warning" is overstated, and that close ECG monitoring is useful only in high-risk patients.
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Cole et al. (2020) conducted a cohort in Patients receiving droperidol in the emergency department (n=16,546). Droperidol was evaluated on Incidence of Torsades des Pointes (TdP) (95% CI 0.00015-0.03367%). Droperidol administration in the emergency department was associated with an extremely rare incidence of Torsades des Pointes, occurring in only 1 of 16,546 patients (0.006%).
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