A double-blind comparison between oral pseudoephedrine and topical oxymetazoline in the prevention of barotrauma during air travel.

To determine the efficacy of two decongestants (oral pseudoephedrine versus topical oxymetazoline) in the prevention of middle ear barotrauma during air travel, 150 adult volunteers with a history of ear pain during air travel were entered into a randomized, double-blind study conducted at two commercial airports. Each subject received 120 mg pseudoephedrine, oxymetazoline hydrochloride (0.05%), or a double placebo (capsule and nasal spray) administered 30 minutes before flight departure. After arrival at their final destinations, volunteers were asked to complete a questionnaire and return it by mail to investigators. Questions included the intensity and duration of otologic symptoms experienced while flying and possible drug side effects. A total of 124 subjects completed the study; 41 received 120 mg of pseudoephedrine, 42 received oxymetazoline nasal spray, and 41 received a double placebo (capsule and nasal spray). The three treatment groups were similar with regard to age, sex, medical history, and flight profile. Symptoms of barotrauma were reported by 34% of those receiving pseudoephedrine versus 71% of the control group, for a relative risk reduction of 52% (95% confidence interval [CI] 33% to 71%). In contrast, 64% of the oxymetazoline group reported symptoms of barotrauma, for a relative risk reduction of 10% (95% CI, 3% to 17%). These results suggest that treatment with 120 mg pseudoephedrine at least 30 minutes before flying appears to decrease the incidence of barotrauma. Oxymetazoline nasal spray is little more effective than placebo in reducing ear pain and discomfort associated with changing ambient pressures.

RCT Entities:   Population Interventions Outcomes