TY - JOUR
T1 - A Randomized Trial of Ketorolac vs Sumatripan vs Placebo Nasal Spray (KSPN) for Acute Migraine
AU - Rao, Aruna S.
AU - Gelaye, Bizu
AU - Kurth, Tobias
AU - Dash, Paul D.
AU - Nitchie, Haley
AU - Peterlin, B. Lee
N1 - Funding Information:
Dr. Peterlin: Grant support from the Landenberger Foundation and GSK within the past 5 years for research studies unrelated to current manuscript. This study was funded by an investigator initiated grant from Luitpold Pharmaceuticals and the NIH/NINDS (K23-NS078345) to Dr. Peterlin and Egalet Ltd to Dr. Gelaye. Dr. Peterlin serves on the editorial boards for the journals Headache and Neurology.
Publisher Copyright:
© 2016 American Headache Society.
PY - 2016/2/1
Y1 - 2016/2/1
N2 - Objective To compare the efficacy of ketorolac nasal spray (NS) vs placebo and sumatriptan NS for the acute treatment of migraine. Methods This was a randomized, double-blind, placebo and active-comparator, crossover study. Adult migraineurs were randomized to ketorolac NS 31.5 mg, sumatriptan NS 20 mg, or placebo to treat three moderate to severe migraine attacks and switched treatments with each attack. Patients seeking headache care at a headache center or in response to community advertisement were recruited. Adult participants with episodic migraine who experienced ≥2 migraine attacks per month were eligible for the Ketorolac vs Sumatriptan vs Placebo Nasal Spray migraine study. Participants were randomized to treatment arms by a research pharmacist, in a 1:1:1 ratio using computer-generated lists. The primary outcome was 2-hour pain relief. Secondary outcomes included 2-hour pain freedom and absence of migraine associated symptoms, and 24-hour sustained pain relief and pain freedom. Results Of the 72 randomized participants, 54 (75%) treated at least one attack and 49 (68%) completed all three treatments, for a total of 152 treated migraine attacks. Both ketorolac NS (72.5%, P <.001) and sumatriptan NS (69.4%, P =.001) were more effective than placebo (38.3%) for 2-hour pain relief and 2-hour pain freedom (ketorolac: 43.1%, P =.004; sumatriptan: 36.7%, P =.046; placebo: 18.4%). Ketorolac NS, but not sumatriptan NS, was more effective than placebo in 2-hour absence of nausea. Both ketorolac NS and sumatriptan NS were more effective than placebo for 24-hour sustained pain relief (ketorolac: 49%, P <.001; sumatriptan: 31%, P =.01, placebo: 20%). Only ketorolac NS was superior to placebo for 24-hour (ketorolac: 35.3%, P =.003; sumatriptan: 22.4%, P =.18, placebo: 12.2%) sustained pain freedom. Nasal burning and dysgeusia were the most common adverse effects for active treatments. Conclusions This study supports that ketorolac NS is superior to placebo and that it is non-inferior to sumatriptan NS for the acute abortive treatment of migraine.
AB - Objective To compare the efficacy of ketorolac nasal spray (NS) vs placebo and sumatriptan NS for the acute treatment of migraine. Methods This was a randomized, double-blind, placebo and active-comparator, crossover study. Adult migraineurs were randomized to ketorolac NS 31.5 mg, sumatriptan NS 20 mg, or placebo to treat three moderate to severe migraine attacks and switched treatments with each attack. Patients seeking headache care at a headache center or in response to community advertisement were recruited. Adult participants with episodic migraine who experienced ≥2 migraine attacks per month were eligible for the Ketorolac vs Sumatriptan vs Placebo Nasal Spray migraine study. Participants were randomized to treatment arms by a research pharmacist, in a 1:1:1 ratio using computer-generated lists. The primary outcome was 2-hour pain relief. Secondary outcomes included 2-hour pain freedom and absence of migraine associated symptoms, and 24-hour sustained pain relief and pain freedom. Results Of the 72 randomized participants, 54 (75%) treated at least one attack and 49 (68%) completed all three treatments, for a total of 152 treated migraine attacks. Both ketorolac NS (72.5%, P <.001) and sumatriptan NS (69.4%, P =.001) were more effective than placebo (38.3%) for 2-hour pain relief and 2-hour pain freedom (ketorolac: 43.1%, P =.004; sumatriptan: 36.7%, P =.046; placebo: 18.4%). Ketorolac NS, but not sumatriptan NS, was more effective than placebo in 2-hour absence of nausea. Both ketorolac NS and sumatriptan NS were more effective than placebo for 24-hour sustained pain relief (ketorolac: 49%, P <.001; sumatriptan: 31%, P =.01, placebo: 20%). Only ketorolac NS was superior to placebo for 24-hour (ketorolac: 35.3%, P =.003; sumatriptan: 22.4%, P =.18, placebo: 12.2%) sustained pain freedom. Nasal burning and dysgeusia were the most common adverse effects for active treatments. Conclusions This study supports that ketorolac NS is superior to placebo and that it is non-inferior to sumatriptan NS for the acute abortive treatment of migraine.
KW - intranasal
KW - ketorolac
KW - migraine
KW - moderate to severe pain
KW - nasal spray
KW - nonsteroidal anti-inflammatory
KW - sumatriptan
KW - treatment
KW - triptan
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U2 - 10.1111/head.12767
DO - 10.1111/head.12767
M3 - Article
C2 - 26840902
AN - SCOPUS:84958963654
SN - 0017-8748
VL - 56
SP - 331
EP - 340
JO - Headache
JF - Headache
IS - 2
ER -