Biswadev MITRA ,1,2 Cristina ROMAN ,1,3 Eric MERCIER,4,5,6 John MOLONEY ,7,8 Gary YIP,9 Keshav KHULLAR,1 Kieran WALSH,1 De Villiers SMIT1,2 and Peter A CAMERON 1,21
Objective: To test the administra- tion of intravenous (i.v.) propofol at a procedural sedation dose com- pared to standard therapy for initial management of migraine in the ED.
Methods: This was an open label, randomised controlled pilot trial. Eli- gible patients were adults with a diagnosis of migraine and planned for treatment with i.v. medications.
Patients were randomised to pro- pofol or standard therapy groups.
The primary outcome variable was time to discharge (TTD) deﬁned as time from intervention to discharge from the ED. Secondary outcomes were safety of propofol administra- tion and change in pain scores. A reduction of pain by ≥50% or dis- charge from the ED was deﬁned as favourable. All analyses were per- formed on an intention-to-treat basis.
Results: Data from 29 patients were analysed, with 15 patients in the propofol group and 14 patients in the standard therapy group. TTD was signiﬁcantly lower in the pro-
pofol group with median of 290 (interquartile range 162–500) min compared to 554.5 (interquartile range 534–639) min in the standard therapy group (P = 0.021). The ha- zard ratio for the deﬁned favourable outcome of reduction of pain scores or discharge from the ED was 1.54 (95% CI 0.69–3.41).
Conclusions: Initial management of migraine with i.v. propofol at proce- dural sedation doses signiﬁcantly reduced TTD compared to standard therapy. We did not detect any sig- niﬁcant safety concerns although the study was not adequately powered to detect safety of the intervention and requires validation.
Key words: analgesia, headache, migraine disorder, pain, propofol.