INTRANASAL LIDOCAINE FOR TREATMENT OF MIGRAINE - A RANDOMIZED, DOUBLE-BLIND, CONTROLLED TRIAL

Objective.-To evaluate the effectiveness of intranasal lidocaine for t reatment of acute migraine headache. Design.-Prospective, randomized, double-blind, placebo-controlled trial. Setting.-Commmunity urgent car e department. Patients.-A total of 81 patients (67 women and 14 men; m edian age, 42 years; range, 19-68 years) with a chief complaint of hea dache 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 t o receive a 4% solution of intranasal lidocaine or saline placebo, res pectively. Main Outcome Measures.-The primary outcome measure was at l east 50% reduction of headache within 15 minutes after treatment. Seco ndary measures include reduction in nausea and photophobia, use of res cue 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 re duced (P=.03 and P=.001, respectively). Rescue medication for headache relief was needed in 15 (28%) of 53 patients in the lidocaine group v s 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 lidoc aine group vs 5 (83%) of 6 in the control group (P=.17), usually withi n the first hour after treatment. Conclusions.-Intranasal lidocaine pr ovides rapid relief of headache in approximately 55% of ambulatory pat ients with migraine. Relapse of headache is common and occurs early af ter treatment.