STUDY OBJECTIVE: To determine the efficacy of decongestant prophylaxis in the prevention of symptoms of middle ear barotrauma (aerotitis media) during air travel. DESIGN: Prospective, parallel, double-blind, randomized trial. SETTING: Two commercial airports in Michigan. TYPE OF PARTICIPANTS: Two hundred fifty volunteers with a history of recurrent ear discomfort during air travel. INTERVENTIONS: Following randomization, each subject received 120 mg pseudoephedrine or placebo 30 minutes before flight departure. Recorded data included subject demographics, history of ear discomfort, and otologic examination. After arrival at their final destinations, volunteers were asked to complete a questionnaire and return it by mail to the investigators. Questions included the intensity and duration of otologic symptoms experienced while flying and possible drug side effects. MEASUREMENTS AND MAIN RESULTS:One hundred ninety subjects completed the study; 96 received 120 mg ofpseudoephedrine and 94 received a placebo. The two treatment groups were similar with regard to age, sex, weight, and flight profile (P > .1). Ear discomfort was present in 32% (31 of 96) of those receiving pseudoephedrine versus 62% (58 of 94) of the control group (chi 2 = 15.34; P = .0001). Adverse effects were minimal; seven patients experienced drowsiness. 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.
RCT Entities:
STUDY OBJECTIVE: To determine the efficacy of decongestant prophylaxis in the prevention of symptoms of middle ear barotrauma (aerotitis media) during air travel. DESIGN: Prospective, parallel, double-blind, randomized trial. SETTING: Two commercial airports in Michigan. TYPE OF PARTICIPANTS: Two hundred fifty volunteers with a history of recurrent ear discomfort during air travel. INTERVENTIONS: Following randomization, each subject received 120 mg pseudoephedrine or placebo 30 minutes before flight departure. Recorded data included subject demographics, history of ear discomfort, and otologic examination. After arrival at their final destinations, volunteers were asked to complete a questionnaire and return it by mail to the investigators. Questions included the intensity and duration of otologic symptoms experienced while flying and possible drug side effects. MEASUREMENTS AND MAIN RESULTS: One hundred ninety subjects completed the study; 96 received 120 mg of pseudoephedrine and 94 received a placebo. The two treatment groups were similar with regard to age, sex, weight, and flight profile (P > .1). Ear discomfort was present in 32% (31 of 96) of those receiving pseudoephedrine versus 62% (58 of 94) of the control group (chi 2 = 15.34; P = .0001). Adverse effects were minimal; seven patients experienced drowsiness. 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.
Authors: Reza Vaezeafshar; Alkis J Psaltis; Vidya K Rao; David Zarabanda; Zara M Patel; Jayakar V Nayak Journal: Allergy Rhinol (Providence) Date: 2017-10-01