EFFICACY OF PSEUDOEPHEDRINE FOR THE PREVENTION OF BAROTRAUMA DURING AIR-TRAVEL

Study objective: To determine the efficacy of decongestant prophylaxis in the prevention of symptoms of middle ear barotrauma ( aerotitis me dia) during air travel. Design: Prospective, parallel, double-blind, r andomized trial. Setting: Two commercial airports in Michigan. Type of participants: Two hundred fifty volunteers with a history of recurren t ear discomfort during air travel. Interventions: Following randomiza tion, each subject received 120 mg pseudoephedrine or placebo 30 minut es before flight departure. Recorded data included subject demographic s, history of ear discomfort, and otologic examination. After arrival at their final destinations, volunteers were asked to complete a quest ionnaire and return it by mail to the investigators. Questions include d the intensity and duration of otologic symptoms experienced while fl ying and possible drug side effects. Measurements and main results: On e hundred ninety subjects completed the study, 96 received 120 mg of p seudoephedrine and 94 received a placebo. The two treatment groups wer e similar with regard to age, sex, weight, and flight profile (P > .1) . Ear discomfort was present in 32% (31 of 96) of those receiving pseu doephedrine versus 62% (58 of 94) of the control group (chi2 = 15.34- P=.0001). Adverse effects were minimal; seven patients experienced dro wsiness. Conclusion: Our results suggest that use of an oral decongest ant before flying decreases the incidence of middle ear barotrauma ass ociated with ambient pressure changes during air travel.