Intranasal lidocaine for the treatment of migraine headache: A randomized,controlled trial

Objective: To evaluate the effect of intranasal lidocaine for immediate rel ief (5 minutes) of migraine headache pain. Methods: A randomized, double-bl ind, placebo-controlled clinical trial at two university-affiliate communit y teaching hospitals enrolled patients 18-50 years old with migraine headac he as defined by the International Headache Society. Patients who were preg nant, lactating, known to abuse alcohol or drugs, or allergic to one of the study drugs, those who used analgesics within two hours, or those with a f irst headache were excluded. Statistical significance was assessed by using chi-square or Fisher's exact test for categorical variables and Student's t-test for continuous variables. Patients rated their pain on a 10-centimet er visual analog scale (VAS) prior to drug administration and at 5, 10, 15, 20, and 30 minutes after the initial dose. Medication was either 1 mL of 4 % lidocaine or normal saline (placebo) intranasally in split doses 2 minute s apart and intravenous prochlorperazine. Medications were packaged so phys icians and patients were unaware of the contents. Successful pain relief wa s achieved if there was a 50% reduction in pain score or a score below 2.5 cm on the VAS. Results: Twenty-seven patients received lidocaine and 22 pla cebo. No significant difference was observed between groups in initial pain scores, 8.4 (95% CI = 7.8 to 9.0) lidocaine and 8.6 (95% CI = 8.0 to 9.2) placebo (p = 0.75). Two of 27 patients (7.4%, 95% CI = 0.8, 24.3) in the li docaine group and three of 22 patients (13.6%, 95% CI = 2.8 to 34.9) in the placebo group had immediate successful pain relief (p = 0.47), with averag e pain scores of 6.9 (95% CI = 5.9 to 7.8) and 7.0 (95% CI = 5.8 to 8.2), r espectively. No difference in pain relief was detected at subsequent measur ements. Conclusion: There was no evidence that intranasal lidocaine provide d rapid relief for migraine headache pain in the emergency department setti ng.