Background: On the basis of a small number of case studies, IV propofol has been advocated for the treatment of chronic daily headache (CDH). There has been no randomized controlled trial of this therapy. Our objective in this randomized, double-blind, placebo-controlled trial was to determine whether a single IV dose of propofol 2.4 mg/kg results in clinically significant reduction in disability or pain in CDH for the next 30 days.
Methods: Eligible adults with CDH received either active treatment with IV propofol infusion (n = 20) or active placebo of IV midazolam (n = 20). The main outcome measures were (a) Headache Disability Inventory (HDI) at 30 days posttreatment, (b) Headache Index, a summary measure of headache intensity over the 30-day period, and (c) analgesic consumption measured as the Medication Quantification Scale version III.
Results: Propofol reduced the HDI by 9.47 points (sd 14.1) at 30 days after injection (P = 0.009), but this is a smaller reduction in headache-related disability than that which the developers of the HDI regard as clinically significant. There was no statistically significant change in HDI for the control group. There were no significant within- or between-group reductions in mean pain intensity as measured by the Headache Index or medication use as measured by the Medication Quantification Scale version III in either group.
Conclusions: A single IV infusion of propofol 2.4 mg/kg produces a statistically significant, but not clinically meaningful, reduction in disability from CDH 30 days after infusion and does not reduce pain intensity or analgesic use. This study does not support this regimen of IV propofol for clinical management of CDH.
Trial registration: ClinicalTrials.gov NCT00228267.