An antihistamine decongestant in the prevention of acute otitis media in children with colds.

Most clinical drug trials relating to acute otitis media have evaluated medications in terms of treatment. In this randomized double-blind, cross-over study, the effectiveness of an antihistamine decongestant in the prevention of AOM was investigated, rather than the treatment. The medication/placebo was started at the onset of a cold and continued throughout its duration. No treatment effect was evident in the results obtained with 308 children who completed the eight-month study. However, the results indicated a strong relationship between colds and AOM, and a trend toward higher occurrence of AOM in children under four years of age.

RCT Entities:   Population Interventions Outcomes