Fourteen subjects were withdrawn from the study because of unexpected changes in their flight schedule, defined as any delay lasting three or more hours. Forty-five volunteers (18%) did not return the study questionnaire and were excluded. All conditions and procedures of the investigation were RESULTSĪ total of 250 subjects satisfied the eligibility criteria, consented to participate, and were enrolled in the study. Posters advertising the study also were distributed around the airport. A booth was set up on the main concourse of each airport for the purpose of soliciting volunteers. The study was conducted at two commercial airports in the Grand Rapids, Michigan, and Detroit metropolitan areas.
All volunteers reported a history of recurrent ear pain during air travel. Two hundred fifty airport commuters were enrolled prospectively in the study. 1 The incidence of barotrauma in "healthy," physically qualified military aircrews ranges from 1.9% to 9%.1, 2 Symptoms include a sensation of ear blockage, followed by pain, tinnitus, vertigo, and a conductive hearing loss. It is the most prevalent medical problem associated with airplane travel and has been a causal factor of aviation accidents. Otic barotrauma, or aerotitis media, refers to tissue damage resulting from failure to equilibrate middle ear and atmospheric pressures. Conclusion: Our results suggest that use of an oral decongestant before flying decreases the incidence of middle ear barotrauma associated with ambient pressure changes during air travel. Adverse effects were minimal seven patients experienced drowsiness. Ear discomfort was present in 32% (31 of 96) of those receiving pseudoephedrine versus 62% (58 of 94) of the control group (χ 2 = 15.34 P =. The two treatment groups were similar with regard to age, sex, weight, and flight profile ( P >. Measurements and main results: One hundred ninety subjects completed the study 96 received 120 mg of pseudoephedrine and 94 received a placebo. Questions included the intensity and duration of otologic symptoms experienced while flying and possible drug side effects. After arrival at their final destinations, volunteers were asked to complete a questionnaire and return it by mail to the investigators. Recorded data included subject demographics, history of ear discomfort, and otologic examination. Interventions: Following randomization, each subject received 120 mg pseudoephedrine or placebo 30 minutes before flight departure. Type of participants: Two hundred fifty volunteers with a history of recurrent ear discomfort during air travel. Setting: Two commercial airports in Michigan. Design: Prospective, parallel, double-blind, randomized trial. Study objective: To determine the efficacy of decongestant prophylaxis in the prevention of symptoms of middle ear barotrauma (aerotitis media) during air travel.
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