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A Randomized, Double-blind, Controlled Trial

Morris Maizels, MD; Barbara Scott; Wendy Cohen, MD; Wansu Chen, MS

JAMA. 1996;276(4):319-321.

Abstract
Objective.
—To evaluate the effectiveness of intranasal lidocaine for treatment of acute migraine headache.

Design.
—Prospective, randomized, double-blind, placebo-controlled trial.

Setting.
—Community 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.

Author Affiliations
From the Departments of Family Practice (Dr Maizels) and Urgent Care (Drs Scott and Cohen), Woodland Hills, and the Department of Research and Evaluation, Pasadena (Ms Chen), Southern California Permanente Medical Group.

Footnotes
Reprints: Morris Maizels, MD, Department of Family Practice, Southern California Permanente Medical Group, 5601 De Soto Ave, Woodland Hills, CA 91365.

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