Comparing propofol with placebo for early resolution of acute migraine in adult emergency department patients: A double-blind randomised controlled trial.

Objective: To compare propofol with placebo in adult ED patients with acute migraine. Primary outcome was headache resolution by 1 h. Secondary outcome was reduction in headache severity by two or more points on a numerical rating scale.

Methods: Double-blind randomised controlled clinical trial comparing propofol (10 mg/mL) with placebo (20% intralipid). Adults with acute migraine without aura were included. The study drug was administered as an initial dose of 4 mL followed by up to five doses of 2 mL, delivered 5 min apart. Pain scores were taken prior to each dose and further administration was ceased when either the pain score was zero or the maximum dosage reached (140 mg of propofol or 14 mL of 20% intralipid).

Results: Of 40 recruited patients, 21 received propofol and 19 placebo. Headache resolution occurred for 5 (24%, 95% CI 13-57) and 6 (32%, 95% CI 13-57) patients, respectively, difference 8% (95% CI -20 to 36). Headache severity reduction by two or more numerical rating scale points was reported by 17 (81%, 95% CI 58-95) and 7 (37%, 95% CI 16-62) patients, respectively, difference 44% (95% CI 17-71).

Conclusions: Propofol was not superior to placebo for the primary outcome of early headache resolution. Superiority of propofol for the secondary outcome of headache severity reduction suggests that further research may be warranted.