Intranasal Lidocaine for the Treatment of Migraine Headache: A Randomized, Controlled Trial

Abstract

Abstract. Objective: To evaluate the effect of intranasal lidocaine for immediate relief (5 minutes) of migraine headache pain. Methods: A randomized, double-blind, placebo-controlled clinical trial at two university-affiliated community teaching hospitals enrolled patients 18-50 years old with migraine headache as defined by the International Headache Society. Patients who were pregnant, 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 first 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-centimeter 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 minutes apart and intravenous prochlorperazine. Medications were packaged so physicians and patients were unaware of the contents. Successful pain relief was achieved if there was a 50% reduction in pain score or a score below 2.5 cm on the VAS. Results: Twentyseven patients received lidocaine and 22 placebo. 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 lidocaine 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 average pain scores of 6.9 (95% CI = 5.9 to 7.8) and 7.0 (95% CI = 5.8 to 8.2), respectively. No difference in pain relief was detected at subsequent measurements. Conclusion: There was no evidence that intranasal lidocaine provided rapid relief for migraine headache pain in the emergency department setting.

A Double‐Blind, Placebo‐Controlled Study of Repetitive Transnasal Sphenopalatine Ganglion Blockade With Tx360® as Acute Treatment for Chronic Migraine

“…Historically, there have been anecdotal reports of SPG blockade as a successful modality to treat migraine and cluster headache, although not all studies have demonstrated success . Recently, Tepper et al demonstrated efficacy of an implanted electrical stimulator in the SPG in a group of subjects with intractable CM .…”

The Sphenopalatine Ganglion: Anatomy, Pathophysiology, and Therapeutic Targeting in Headache

“…There have been a number of studies published over the years on SPG blockade, using intranasal lidocaine for the treatment of migraine, including one case report, an uncontrolled study, and four small, randomized trials . In 1999, Maizels published a case report of a 15‐year‐old boy who had episodic migraine with aura.…”

“…Side effects, which were transient and not serious, included bitter taste, nostril burning, and oropharyngeal numbness. Another randomized controlled study found that 1 mL of 4% intranasal lidocaine was not better than placebo in the acute treatment of migraine for patients presenting to the emergency department (ED) …”

Italian guidelines for primary headaches: 2012 revised version

“…Results of randomized, double-blind studies indicate a modest, but significant efficacy although with frequent and early recurrence [102, 103]. …”