A Prospective, Randomized Trial of Intravenous Prochlorperazine Versus Subcutaneous Sumatriptan in Acute Migraine Therapy in the Emergency Department
Study objective
Intravenous (IV) prochlorperazine with diphenhydramine is superior to subcutaneous sumatriptan in the treatment of migraine patients presenting to the emergency department (ED).
Methods
In this randomized, double-blind, placebo-controlled trial, after providing written informed consent, patients presenting to the ED with a chief complaint of migraine received a 500-mL bolus of IV saline solution and either 10 mg prochlorperazine with 12.5 mg diphenhydramine IV plus saline solution placebo subcutaneously or saline solution placebo IV plus 6 mg sumatriptan subcutaneously. Pain intensity was assessed with 100-mm visual analog scales (visual analog scale at baseline and every 20 minutes for 80 minutes). The primary outcome was change in pain intensity from baseline to 80 minutes or time of ED discharge if subjects remained in the ED for fewer than 80 minutes after treatment. Sedation and nausea were assessed every 20 minutes with visual analog scale scales, and subjects were contacted within 72 hours to assess headache recurrence.
Results
Sixty-eight subjects entered the trial, with complete data for 66 subjects. Baseline pain scores were similar for the prochlorperazine/diphenhydramine and sumatriptan groups (76 versus 71 mm). Mean reductions in pain intensity at 80 minutes or time of ED discharge were 73 mm for the prochlorperazine/diphenhydramine group and 50 mm for those receiving sumatriptan (mean difference 23 mm; 95% confidence interval 11 to 36 mm). Sedation, nausea, and headache recurrence rates were similar.
Conclusion
IV prochlorperazine with diphenhydramine is superior to subcutaneous sumatriptan in the treatment of migraine.
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Supervising editor: Knox H. Todd, MD, MPH
Author contributions: MAK was the faculty advisor, conceived the study and design, edited institutional review board proposal, supervised logistics, and wrote the article. FJG, TSM, and RTG assisted with study design. FJG and TSM assisted with logistics and follow-up. FJG prepared the study for the institutional review board and was in charge of data collection. TSR performed all statistical calculations and assisted with article preparation. RTG performed randomization, prepared all drug packets, and kept the master list linking subjects with study packets. MAK takes responsibility for the paper as a whole.
Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article that might create any potential conflict of interest. The authors have stated that no such relationships exist. See the Manuscript Submission Agreement in this issue for examples of specific conflicts covered by this statement.
Publication date: Available online January 4, 2010.
Reprints not available from the authors.
PII: S0196-0644(09)01794-6
doi:10.1016/j.annemergmed.2009.11.020
© 2009 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.
