Intranasal ketorolac is superior to placebo and noninferior to intranasal sumatriptan for the acute abortive treatment of moderate to severe migraine, according to data published in the February issue of Headache. Intranasal ketorolac may be appropriate for patients whose nausea makes the use of oral medications difficult, and the formulation also offers an effective alternative for patients who cannot or do not want to use a triptan nasal spray, according to the authors.
Research suggests that parenteral ketorolac may be as effective as or more effective than certain triptans and other acute abortive therapies. No previous study, however, had directly compared intranasal ketorolac with any migraine-specific therapy.
Aruna S. Rao, MD, Instructor of Neurology at Johns Hopkins University School of Medicine in Baltimore, and colleagues conducted a prospective, double-blind, double-dummy trial at an outpatient headache center in Baltimore from March 2013 to December 2014. Eligible patients were age 18 or older, had a history of episodic migraine for at least one year, and had two to 10 migraine attacks per month.
Participants were randomized in groups of equal size to one of six sequences of ketorolac nasal spray (31.5 mg), sumatriptan nasal spray (20 mg), and placebo. Each participant treated three moderate to severe migraine attacks and received a different treatment for each attack. During the 48 hours following the use of each treatment, patients used a four-point scale to assess headache severity, migraine-associated symptoms, and disability.
The study’s primary outcome was two-hour headache relief. Secondary outcomes included two-hour pain freedom, two-hour absence of migraine-associated symptoms, absence of allodynia, disability, and 24- and 48-hour sustained pain relief and sustained pain freedom.
In all, 72 participants were randomized, 54 used at least one dose of study medication, and 49 treated three attacks. A total of 152 attacks were analyzed. Patients’ mean age was 36. Approximately 80% of patients were Caucasian, and 98% were female.
About 73% of patients treated with ketorolac had two-hour pain relief, compared with 69% of patients treated with sumatriptan and 39% of controls. Ketorolac and sumatriptan thus were superior to placebo. In addition, 43% of patients treated with ketorolac had two-hour pain freedom, compared with 37% of patients treated with sumatriptan and 18% of controls. Ketorolac and sumatriptan were superior to placebo for time to pain relief, two-hour freedom from photophobia, and two-to-24-hour sustained pain relief. Only ketorolac was superior to placebo for two-hour freedom from nausea and phonophobia, two-to-24-hour sustained pain freedom, two-to-48-hour sustained pain relief, and two-to-48-hour sustained pain freedom.
The researchers found no statistically significant difference in two-hour freedom from allodynia in participants treated with ketorolac or sumatriptan, compared with placebo. In the first two hours after study treatment, participants who used ketorolac were 61% less likely, and participants who used sumatriptan were 53% less likely, to use rescue medication, compared with placebo. The most common adverse events reported for ketorolac and sumatriptan were nasal burning and an unusual taste. Both were mild to moderate for the majority of patients.
—Erik Greb