Effectiveness and safety of droperidol in a United States emergency department

Response to: “Limitations of Retrospective Chart Reviews to Determine Rare Events, and the Unknown Relative Risk of Droperidol”

“…We believe, regardless of the precision of our measurement, our data reflect truth in the universe: that droperidol-induced TdP is exceedingly rare, as has been confirmed in other studies both outside 6 and within the ED. 7,8 While the exact incidence of droperidol-induced TdP can be debated, we believe one of the more important findings of our study is that we did find such a case. Drug-induced TdP, in general, is quite rare.…”

The Incidence of QT Prolongation and Torsades des Pointes in Patients Receiving Droperidol in an Urban Emergency Department

“…41 Recently another American group evaluated 6,353 ED encounters where patients received droperidol and found the incidence of a QTc>500 ms was 1.2% in the six months prior to receiving droperidol, and 0.7% after receiving droperidol. 42 None of these patients suffered TdP or died. We recently published a review that included 4,947 patients who received a median dose of 5 mg intramuscular (IM) droperidol for acute behavioral disturbance from 2012-2013; no patients suffered cardiac arrest.…”

“…Because the risk of drug-induced TdP is directly proportional to the heart rate (bradycardia prolongs the vulnerable period where a depolarization could trigger TdP) Bazett’s correction over-estimates the risk of the QT interval in tachycardic patients, and under-estimates the risk in bradycardic patients. 26 Nevertheless, Bazett’s correction is commonly used in the droperidol literature, 42 and is the most common formula used by toxicologists to risk stratify patients for TdP. 47 We attempted to account for this limitation by using the QT nomogram, a tool with greater sensitivity and specificity for detecting drug-induced TdP.…”

Clinical Pharmacist Services in the Emergency Department

“…Five of these deaths involved exposure to doses of 2.5 mg or less. 8 Eventually, the FDA conceded that the black box warning did not apply for doses of droperidol less than 2.5 mg. 9 Since that time, droperidol use has been studied in thousands of ED cases without any occurrence of fatal dysrhythmias, with dosing in many cases more than 10 mg. 10,11 Multiple trials published since the black box warning confirm the safety and potential superiority of low-dose droperidol for the treatment of nausea and vomiting in the ED. 12 A study of ED patients presenting with nausea showed that droperidol (1.25 mg given intravenously) reduced symptoms better than metoclopramide or prochlorperazine (change in nausea on 100 mm visual analog scale: -54.5 mm, -40.2 mm, and -40.5 mm, respectively), with the only adverse effect being selfreported restlessness or anxiety at 24-hour follow-up (71%, 25%, and 35%, respectively), with more than 90% satisfaction regardless of group.…”