DOUBLE-BLIND, MULTICENTER TRIAL TO COMPARE THE EFFICACY OF INTRAMUSCULAR DIHYDROERGOTAMINE PLUS HYDROXYZINE VERSUS INTRAMUSCULAR MEPERIDINEPLUS HYDROXYZINE FOR THE EMERGENCY DEPARTMENT TREATMENT OF ACUTE MIGRAINE HEADACHE

Study objective: To evaluate intramuscular dihydroergotamine in direct comparison with opioid analgesia in the treatment of acute migraine h eadache. Methods: This was a prospective, multicenter, double-blind tr ial performed in the emergency departments of 11 general hospitals in the United States. One hundred seventy-one patients between the ages o f 18 and 60 years who presented to the ED with acute migraine headache were enrolled. Patients were randomly assigned to receive either 1 mg dihydroergotamine (DHE) or 1.5 mg/kg meperidine (MEP) by intramuscula r injection. The anti-nauseant hydroxyzine (H) was coadministered in b oth treatment groups. Results: One hundred fifty-six patients were eva luable. Treatment groups were comparable in sample size, demographics, and baseline measurements of headache pain. Reduction of headache pai n as measured on a 100-mm visual analog scale was 41 +/- 33 mm (53.5% reduction) for the DHE group, and 45 +/- 30 mm (55.7% reduction) for t he MEP group at 60 minutes after treatment (difference=2.2%; 95% confi dence interval [CI] -10%, 14.5%; P = .81). Reduction in the severity o f nausea and improvement in functional ability were similar between tr eatment groups. Central nervous system adverse events were less common in the DHE group (DHE 23.5% versus MEP 37.6%, difference = -14.1%: 95 % CI -28%, 0%). In particular, dizziness was reported less commonly wi th DHE than MEP (2% versus 15%, difference= -13%: 95% CI -21%, -5%). C onclusion: In this prospective, double-blind trial of a convenience sa mple of ED patients randomly assigned to one of two treatment regimens , DHE and MEP were comparable therapies for acute migraine. The use of DHE avoids several problems associated with opioid analgesia, includi ng dizziness.