Postdischarge secobarbital after ED migraine treatment decreases pain and improves resolution

Objective: The objective of the study was to determine whether the addition of postdischarge oral secobarbital to standard emergency department (ED) migraine headache therapy improves pain relief and headache resolution compared with placebo. Setting: The setting is an urban ED with 70 000 yearly visits. Methods: This is an Institutional Review Board-approved, randomized, nonconsecutive, double-blinded, concealed, and placebo-controlled clinical trial. Patients with a clinical diagnosis of migraine underwent standard ED treatment and were discharged with 2 tablets of either secobarbital 100 mg or placebo. At home arrival, subjects recorded headache pain on a visual analog scale (VAS), took 1 tablet, and went to bed, taking the second tablet after 1 hour if not asleep. Upon awakening, subjects completed a second VAS and survey. Statistical analysis: The VAS data were analyzed using 2-tailed t test with unequal variance. Headache resolution data were analyzed using Fisher exact test. Results: Fifty subjects were enrolled. Complete data and follow-up were available for 30 subjects (60%). Fourteen subjects received placebo; 16 received secobarbital. Secobarbital subjects reported an average headache pain decrease of 25 mm (-13 to -38) compared with an average increase of 3 mm (-13 to 19) in the placebo group (P = .01). Ninety-four percent of the secobarbital group vs 50% of the placebo group had complete or partial headache resolution (P < .02). All subjects in the secobarbital group reported some relief. Conclusions: Addition of postdischarge oral secobarbital to a standard ED migraine treatment regimen decreased headache pain at 24 hours after discharge and improved the rate of headache resolution compared with placebo. © 2011 Elsevier Inc.