What is Droperidol (Butyrophenone derivative)?

From the Guidelines

Droperidol should be used with caution and only when first-line drugs are unsuccessful due to its potential for QT prolongation and risk of sudden cardiac death, as indicated by the black-box warning added to its product label 1.

Key Points

• Droperidol is a neuroleptic agent used as an adjunct to standard sedation for complex endoscopic procedures or difficult-to-sedate patients, with an onset of action of 3-10 minutes and a duration of effect of 2-4 hours 1.
• The usual dose of droperidol for endoscopic sedation is 1.25-2.5 mg intravenously, although higher doses have been used 1.
• Major side effects of droperidol include hypotension, prolongation of the QTc interval, and extrapyramidal signs 1.
• Droperidol use is contraindicated in patients with a prolonged QTc interval (440 ms in males, 450 ms in females) and should be avoided in patients at increased risk of developing QT interval prolongation 1.

Recommendations

• Droperidol should be avoided in most circumstances due to its potential risks and the availability of shorter-acting sedatives 1.
• When administering droperidol, cardiac monitoring should be available, and lower doses should be considered in elderly patients or those with hepatic impairment 1.
• Patients with known QT prolongation, electrolyte abnormalities, or concurrent use of other QT-prolonging medications should avoid droperidol 1.

Clinical Considerations

• Droperidol may still be valuable in emergency settings and perioperative care due to its rapid onset and effectiveness against nausea and agitation 1.
• However, its use should be carefully weighed against the potential risks, and alternative sedatives should be considered whenever possible 1.

From the FDA Drug Label

WARNING Cases of QT prolongation and/or torsade de pointes have been reported in patients receiving droperidol at doses at or below recommended doses. Cases of QT prolongation and serious arrhythmias (e.g., torsade de pointes) have been reported in patients treated with droperidol. Droperidol is contraindicated in patients with known or suspected QT prolongation, including patients with congenital long QT syndrome.

Droperidol may cause QT prolongation and/or torsade de pointes, which can be fatal.

• It is contraindicated in patients with known or suspected QT prolongation, including those with congenital long QT syndrome.
• Patients should undergo a 12-lead ECG prior to administration of droperidol to determine if a prolonged QT interval is present.
• ECG monitoring should be performed prior to treatment and continued for 2-3 hours after completing treatment to monitor for arrhythmias 2.

From the Research

Overview of Droperidol

• Droperidol is a butyrophenone used in emergency medicine practice for various purposes, including treatment of nausea, headache, and agitation 3.
• It has antiemetic, sedative, anxiolytic, and analgesic properties, making it a versatile medication in clinical settings 4.

Safety and Efficacy

• Studies have shown that droperidol is effective and safe when used as an analgesic, antiemetic, and sedative in emergency departments 5, 4.
• The medication has been found to have equal or greater efficacy in reducing nausea and vomiting compared to other antiemetics like ondansetron and metoclopramide, with similar adverse effects 4.
• Droperidol has also been shown to be effective in treating migraines and has opioid-sparing effects when used to treat abdominal pain, making it a useful adjunct in patients who are opioid-tolerant 4.

QT Prolongation and Cardiac Risks

• Droperidol carries a boxed warning from the US Food and Drug Administration for QT prolongation and torsades des pointes (TdP) 6.
• However, studies have found that the incidence of QT prolongation and TdP in patients receiving droperidol is extremely rare, suggesting that the FDA's black box warning may be overstated 6.
• The mean QTc interval prolongation after droperidol administration has been found to be significant, but the clinical relevance of this effect is still debated 7, 6.

Clinical Use and Monitoring

• The American Academy of Emergency Medicine has stated that droperidol is an effective and safe medication for the treatment of nausea, headache, and agitation, and that routine electrocardiogram or telemetry monitoring is not necessary for doses less than 2.5 mg 3.
• However, close ECG monitoring may be useful in high-risk patients, such as those with pre-existing cardiac conditions or taking other medications that can prolong the QT interval 6.