Metoclopramide for acute migraine: a dose-finding randomized clinical trial
Abstract
Background Intravenous metoclopramide is effective as primary therapy for acute migraine but the optimal dose of this medication is not yet known. Methods This was a randomized, double-blind, dose finding study conducted on patients who presented to our emergency department (ED) meeting International Classification of Headache Disorders criteria for migraine without aura. We randomized patients to 10mg, 20mg, or 40mg of intravenous metoclopramide. We co-administered diphenhydramine to all patients to prevent extra-pyramidal side effects. The primary outcome was improvement in pain on an 11 point Numerical Rating Scale (NRS) at one hour. Secondary outcomes included sustained pain freedom at 48 hours and adverse effects. Results In this study, 356 patients were randomized. Baseline demographics and headache features were comparable among the groups. At one hour, those who received 10mg improved by a mean of 4.7 NRS points (95%CI: 4.2, 5.2); those who received 20mg improved by 4.9 (95%CI: 4.4, 5.4), and those who received 40mg improved by 5.3(95%CI: 4.8, 5.9). Rates of 48 hour sustained pain freedom in the 10, 20, and 40mg groups were: 16% (95%CI:10,24%), 20% (95%CI:14,28%), and 21% (95%CI:15,29%), respectively. The most commonly occurring adverse event was drowsiness, which impaired function in 17% (95%CI: 13,21%) of the overall study population. Akathisia developed in 33 patients. Both drowsiness and akathisia were evenly distributed across the 3 arms of the study. One month…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 356 participants or records.
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