title: A Randomized Trial of Ketorolac vs. Sumatripan vs. Placebo Nasal Spray (KSPN) for Acute Migraine.
abstract: 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.
authors: Johns Hopkins University School of Medicine, Department of Neurology, Baltimore, MD, USA.
authors: Aruna S
authors: AS
authors: Rao
authors: Harvard T.H. Chan School of Public Health, Department of Epidemiology, Boston, MA, USA.
authors: Bizu
authors: B
authors: Gelaye
authors: Institute of Public Health, Charité Universitätsmedizin Berlin, Germany.|Division of Preventive Medicine, Brigham and Women's Hospital, Boston, MA.
authors: Tobias
authors: T
authors: Kurth
authors: Johns Hopkins Community Physicians, Department of Neurology, Baltimore, MD, USA.
authors: Paul D
authors: PD
authors: Dash
authors: Johns Hopkins University School of Medicine, Department of Neurology, Baltimore, MD, USA.
authors: Haley
authors: H
authors: Nitchie
authors: Johns Hopkins University School of Medicine, Department of Neurology, Baltimore, MD, USA.
authors: B Lee
authors: BL
authors: Peterlin
mesh_terms: D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004185:Disability Evaluation; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006930:Hyperalgesia / Q000188:drug therapy / Q000209:etiology; D020910:Ketorolac / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000150:complications / Q000188:drug therapy*; D065588:Nasal Absorption; D017288:Pain Threshold / Q000187:drug effects; D058825:Serotonin 5-HT1 Receptor Agonists / Q000008:administration & dosage*; D018170:Sumatriptan / Q000008:administration & dosage*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D058825:Serotonin 5-HT1 Receptor Agonists; D018170:Sumatriptan; D020910:Ketorolac
keywords: intranasal; ketorolac; migraine; moderate to severe pain; nasal spray; nonsteroidal anti-inflammatory; sumatriptan; treatment; triptan