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Randomized Controlled Trial Multicenter Study
Intravenous Cetirizine Versus Intravenous Diphenhydramine for the Treatment of Acute Urticaria: A Phase III Randomized Controlled Noninferiority Trial.
- Benjamin S Abella, William E Berger, Michael S Blaiss, Ian G Stiell, Joseph P Herres, Joseph J Moellman, Selim Suner, Adam Kessler, Howard A Klausner, Jeffrey M Caterino, and Jie Du.
- Center for Resuscitation Science, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA. Electronic address: benjamin.abella@pennmedicine.upenn.edu.
- Ann Emerg Med. 2020 Oct 1; 76 (4): 489-500.
Study ObjectiveAcute urticaria is a frequent presentation in emergency departments (EDs), urgent care centers, and other clinical arenas. Treatment options are limited if diphenhydramine is the only intravenous antihistamine offered because of its short duration of action and well-known adverse effects. We evaluate cetirizine injection, the first second-generation injectable antihistamine, for acute urticaria in this multicenter, randomized, noninferiority, phase 3 clinical trial.MethodsAdult patients presenting to EDs and urgent care centers with acute urticaria requiring an intravenous antihistamine were randomized to either intravenous cetirizine 10 mg or intravenous diphenhydramine 50 mg. The primary endpoint was the 2-hour pruritus score change from baseline, with time spent in treatment center and rate of return to treatment centers as key secondary endpoints. Frequency of sedation and anticholinergic adverse effects were also recorded.ResultsAmong 262 enrolled patients, the 2-hour pruritus score change from baseline for intravenous cetirizine was statistically noninferior to that for intravenous diphenhydramine (-1.6 versus -1.5; 95% confidence interval -0.1 to 0.3), and in favor of cetirizine. Treatment differences also favored cetirizine for mean time spent in treatment center (1.7 versus 2.1 hours; P=.005), return to treatment center (5.5% versus 14.1%; P=.02), lower change from baseline sedation score at 2 hours (0.1 versus 0.5; P=.03), and adverse event rate (3.9% versus 13.3%).ConclusionIntravenous cetirizine is an effective alternative to intravenous diphenhydramine for treating acute urticaria, with benefits of less sedation, fewer adverse events, shorter time spent in treatment center, and lower rates of revisit to treatment center.Copyright © 2020 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.
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