M Maizels1, A M Geiger. 1. Department of Family Practice, Southern California Permanente Medical Group, Woodland Hills, CA, USA.
Abstract
OBJECTIVE: To study the efficacy of intranasal lidocaine for the treatment of migraine when administered by subjects in a nonclinic setting. DESIGN: A 1-month, randomized, controlled, double-blind trial, followed by a 6-month open-label follow-up. SETTING:Ambulatory subjects treating themselves outside of a medical setting. SUBJECTS:One hundred thirty-one adult subjects with migraine, diagnosed according to International Headache Society criteria, were enrolled in the study: 113 treated at least one headache in the controlled trial, and 74 treated at least one headache in the open-label phase. All subjects were members of the Kaiser Permanente Southern California Medical Care Program and were recruited at two urban medical centers. INTERVENTION: Intranasal lidocaine 4% or saline placebo 0.5 mL was dropped into the nostril on the side of the headache, or bilaterally for bilateral headache, according to study protocol. MAIN OUTCOME MEASURES: Trial: percent of headaches relieved to mild or none at 15 minutes and relapse of headache within 24 hours. Open-label: percent of headaches relieved to mild or none at 15 and 30 minutes and relapse within 24 hours. RESULTS: In the controlled trial, headache was relieved within 15 minutes in 34 (35.8%) of 95 subjects treated with 4% intranasal lidocaine compared with 8 (7.4%) of 108 subjects receiving placebo (P < .001). Headaches relapsed in 7 (20.6%) of 34 subjects treated with 4% intranasal lidocaine compared to 0 of 8 placebo subjects (P = .312). In the open-label follow-up, headaches were relieved in 129 (41.2%) of 313 episodes within 15 minutes and in 141 (57.6%) of 245 episodes after 30 minutes. Headaches relapsed in 28 (19.9%) of 140. The response did not diminish over time: 32 (62.8%) of 51 first headaches were relieved at 30 minutes and 10 (71.4%) of 14 seventh headaches were relieved. Relapse occurred in 28 (20%) [corrected] of 129 headaches at a mean time (+/- SD) of 7.4 (+/- 6.6) hours. CONCLUSION:Intranasal lidocaine 4% provides rapid relief of migraine symptoms. For those subjects who do respond, the effect does not diminish over 6-month follow-up.
RCT Entities:
OBJECTIVE: To study the efficacy of intranasal lidocaine for the treatment of migraine when administered by subjects in a nonclinic setting. DESIGN: A 1-month, randomized, controlled, double-blind trial, followed by a 6-month open-label follow-up. SETTING: Ambulatory subjects treating themselves outside of a medical setting. SUBJECTS: One hundred thirty-one adult subjects with migraine, diagnosed according to International Headache Society criteria, were enrolled in the study: 113 treated at least one headache in the controlled trial, and 74 treated at least one headache in the open-label phase. All subjects were members of the Kaiser Permanente Southern California Medical Care Program and were recruited at two urban medical centers. INTERVENTION: Intranasal lidocaine 4% or saline placebo 0.5 mL was dropped into the nostril on the side of the headache, or bilaterally for bilateral headache, according to study protocol. MAIN OUTCOME MEASURES: Trial: percent of headaches relieved to mild or none at 15 minutes and relapse of headache within 24 hours. Open-label: percent of headaches relieved to mild or none at 15 and 30 minutes and relapse within 24 hours. RESULTS: In the controlled trial, headache was relieved within 15 minutes in 34 (35.8%) of 95 subjects treated with 4% intranasal lidocaine compared with 8 (7.4%) of 108 subjects receiving placebo (P < .001). Headaches relapsed in 7 (20.6%) of 34 subjects treated with 4% intranasal lidocaine compared to 0 of 8 placebo subjects (P = .312). In the open-label follow-up, headaches were relieved in 129 (41.2%) of 313 episodes within 15 minutes and in 141 (57.6%) of 245 episodes after 30 minutes. Headaches relapsed in 28 (19.9%) of 140. The response did not diminish over time: 32 (62.8%) of 51 first headaches were relieved at 30 minutes and 10 (71.4%) of 14 seventh headaches were relieved. Relapse occurred in 28 (20%) [corrected] of 129 headaches at a mean time (+/- SD) of 7.4 (+/- 6.6) hours. CONCLUSION: Intranasal lidocaine 4% provides rapid relief of migraine symptoms. For those subjects who do respond, the effect does not diminish over 6-month follow-up.
Authors: Dimitrios N Katsaras; Chrysa K Arvaniti; Panayota G Flevari; Georgios V Giannopoulos; Chrysanthi Z Batistaki; Vassilios E Stassinos; Georgia G Kostopanagiotou; Spyridon G Deftereos; Efstathios K Iliodromitis; Dionyssios I Leftheriotis Journal: Ann Transl Med Date: 2018-12