Metoclopramide versus sumatriptan in the treatment of migraine in the emergency department: a single-center, open-label, cluster-randomized controlled non-inferiority trial

Abstract Background Migraine is a common disease seen in the emergency department (ED). Triptans, which are recommended in therapeutic guidelines for migraine, have some contraindications and possible severe side effects. Metoclopramide, which is commonly used as an antiemetic, also seems to have pain-relieving effects for migraine. In this study, we will investigate whether metoclopramide 10 mg intravenously (IV) is non-inferior to sumatriptan 3 mg subcutaneously (SQ) as migraine treatment in the ED. Methods This study is a single-center, open-label, cluster-randomized controlled trial of 80 patients with migraine attacks to investigate the non-inferiority of metoclopramide to sumatriptan. The patients will be cluster-randomized monthly into metoclopramide 10 mg IV and sumatriptan 3 mg SQ arms. The primary outcome will be change in Numerical Rating Scale score for headache at 1 h after baseline. Discussion If our hypothesis is confirmed, metoclopramide can be considered as first-line medication for migraine attacks in ED settings.