Acute migraine treatment with droperidol - A randomized, double-blind, placebo-controlled trial

Background: The treatment of a migraine attack can be difficult when first-line medication is unsuccessful and options for parenteral "rescue" therapy are limited. Methods: A randomized, double-blind, placebo-controlled, dose-ranging, multicenter study was conducted to assess the efficacy and tolerability of droperidol 0.1 mg, 2.75 mg, 5.5 mg, and 8.25 mg for the acute treatment of moderate to severe migraine headache in adults. Results: A total of 331 patients were enrolled; 305 were treated. Headache response at 2 hours was better (p < 0.002) in the treatment groups receiving droperidol IM at doses of 2.75 mg (87%), 5.5 mg (81%), and 8.25 mg (85%) compared with placebo (57%). The percent of patients achieving a pain-free response at 2 hours after treatment was significantly greater than placebo for the droperidol 2.75-mg, 5.5-mg, and 8.25-mg dose groups. The frequency of headache recurrence (within 24 hours) for patients initially responding by 2 hours was lower in patients treated with droperidol than placebo, but differences failed to reach significance. A significantly greater percentage of patients receiving droperidol 2.75 mg reported the elimination of migraine-associated symptoms (nausea, vomiting, photophobia, and phonophobia) than those who received placebo. Although most adverse events were of mild or moderate intensity, anxiety, akathisia, and somnolence were rated as severe in 30% of patients who experienced those symptoms. Hypotension was uncommon. No patient had QT prolongation.