Conditions: Migraines
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 72
Healthy volunteers: no

Brief summary:
The investigators propose to test the efficacy of ketorolac nasal spray versus sumatriptan nasal spray versus placebo for acute abortive therapy of migraine head pain as well as for migraine associated symptoms including nausea and allodynia.

Detailed description:
Participants are 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 so that they received each treatment only once.

For each treated attack (moderate to severe migraine attack), participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.

Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo

Arms:
arm 1: Ketorolac 31.5 mg single dose nasal spray and Placebo arm 2: Sumatriptan 20 mg single dose nasal spray and placebo arm 3: single dose Ketorolac placebo, single dose Sumatriptan placebo

Interventions: intervention 1: Ketorolac intervention 2: Sumatriptan intervention 3: Placebo
Intervention descriptions: intervention 1: Single dose of Ketorolac (Sprix) nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack. intervention 2: Sumatriptan (Imitrex) 20 mg one single dose of nasal spray for an acute migraine attack. intervention 3: Placebo one spray in each nostril and placebo one nasal spray.

Protocol document: