Pseudoephedrine for the prevention of barotitis media: a controlled clinical trial in underwater divers.

STUDY OBJECTIVE

To determine the efficacy and safety of decongestant prophylaxis among first-time underwater divers in the prevention of barotitis media (middle ear squeeze).

DESIGN

Randomized, double-blind, prospective clinical trial.

SETTING

Recreational diving schools in Panama City, Florida.

TYPE OF PARTICIPANTS

One hundred twenty volunteer scuba divers under the supervision of certified instructors.

INTERVENTIONS

After randomization, each subject received a 60-mg tablet of pseudoephedrine or placebo 30 minutes before diving. Prospective data were collected, including subject demographics, signs and symptoms of middle ear squeeze during the dive, and possible drug side effects. The otoscopic appearance of the tympanic membrane was graded according to the amount of hemorrhage in the eardrum, with Teed scores ranging from 0 (normal) to 5 (gross hemorrhage and rupture). chi 2 and t-tests were applied with significance set at P less than .05). The Mantel-Haenszel test was used to test the null hypothesis that the mean Teed scores of the two treatment groups were equal.

RESULTS

A total of 116 subjects met the inclusion criteria and completed the study; 60 received 60 mg pseudoephedrine, and 56 received placebo. The treatment groups were similar with regard to age, sex, medical history, and depth of the first dive (P greater than .5). Ear discomfort and blockage during the dive were present in 8% (five of 60) of those receiving pseudoephedrine versus 32% (18 of 56) of the control group (P = .001). Similarly, the pseudoephedrine group had smaller Teed scores after diving than did the control subjects (P = .003). Adverse effects were minimal; two patients experienced dizziness and nausea.

CONCLUSION

These results suggest that the use of an oral decongestant before diving decreases the incidence and severity of middle ear squeeze in novice divers.