Objective.-To evaluate the effectiveness of intranasal lidocaine for treatment of acute migraine headache. Design.-Prospective, randomized, double-blind, placebo-controlled trial. Setting.-Commmunity urgent care department. Patients.-A total of 81 patients (67 women and 14 men; median age, 42 years; range, 19-68 years) with a chief complaint of headache who fulfilled criteria of the International Headache Society for migraine participated. Patients were excluded if headache had lasted more than 3 days or if the frequency of severe headache was more than once per week. Intervention.-Patients were randomized in a 2:1 ratio to receive a 4% solution of intranasal lidocaine or saline placebo, respectively. Main Outcome Measures.-The primary outcome measure was at least 50% reduction of headache within 15 minutes after treatment. Secondary measures include reduction in nausea and photophobia, use of rescue medication, relapse of headache, and change in headache disability scores. Results.-Of 53 patients who received intranasal lidocaine, 29 (55%) had at least a 50% reduction of headache compared with 6 (21 %) of 28 controls (P=.004). Nausea and photophobia were significantly reduced (P=.03 and P=.001, respectively). Rescue medication for headache relief was needed in 15 (28%) of 53 patients in the lidocaine group vs 20 (71%) of 28 controls (P<.001). Among those with initial relief of headache, relapse of headache occurred in 10 (42%) of 24 in the lidocaine group vs 5 (83%) of 6 in the control group (P=.17), usually within the first hour after treatment. Conclusions.-Intranasal lidocaine provides rapid relief of headache in approximately 55% of ambulatory patients with migraine. Relapse of headache is common and occurs early after treatment.