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

Abstract

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.

The effectiveness of parenteral agents for pain reduction in patients with migraine presenting to emergency settings: A systematic review and network analysis

“…Nearly half of the included studies were conducted in the USA, 10,11,40–76 followed in frequency by Iran, 9,77–87 Turkey, 88–99 Brazil, 35–39,100,101 Canada, 102–107 Germany, 108–112 Australia, 113–117 Spain, 118,119 Mexico, 120,121 Sweden, 122 Finland, 123 and New Zealand 124 . Five studies enrolled patients from multiple international sites 125–129 .…”

“…Four studies assessed sedatives/hypnotics, with three studies providing various doses of intravenous propofol, 83,116,117 while the remaining study administered a single 0.2 mg/kg IV dose of ketamine 10 …”

“…The remaining studies most frequently utilized a 4-point verbal rating scale (i.e., 0 = no pain, 1 = mild pain, 2 = moderate pain, and 3 = severe pain) [35][36][37][38][39]41,42,44,52,62,63,66,68,72,75,96,97,101,106,108,109,118,[120][121][122]124,[126][127][128][129] or a 10-or 11-point numeric rating scale. 10,11,40,45,[55][56][57][58]84,85,89,92,100,102,106,115,116,130 Six studies measured pain using other scales including the Borg scale, 50 an unspecified 1-5 point Likert scale, 69 a 0-4 poi...…”

“…Four studies assessed sedatives/hypnotics, with three studies providing various doses of intravenous propofol, 83,116,117 while the remaining study administered a single 0.2 mg/kg IV dose of ketamine. 10 Lidocaine Three studies assessed intravenous lidocaine at various doses including a single 1 mg/kg dose 114 and two 20 mg doses.…”

Second‐line interventions for migraine in the emergency department: A narrative review

“…In this study, pain scores between the groups were comparable, though patients who received propofol were able to be discharged sooner. The second was a randomized, double‐blind, placebo‐controlled study 28 . Propofol failed to outperform placebo with regard to headache freedom, use of rescue medication, or desire to receive the same medication again, though a greater percentage of participants who received propofol reported a reduction in pain scores.…”