Prevention of recurrent acute otitis media: chemoprophylaxis versus tympanostomy tubes.

Otitis media has long been recognized as one of the most common diseases of childhood. Several therapeutic modalities have been advocated for the prevention of recurrent episodes of acute otitis media (AOM). A blinded, prospective, randomized study was designed to determine the efficacy of tympanostomy tubes, antibiotic prophylaxis, and placebo. Children with recurrent AOM were entered in the study and followed for at least 6 months. A total of 65 children completed the protocol. Sixty-three of those were under the age of 4 years. Treatment failure was defined as two or more episodes of AOM or otorrhea in less than 3 months. Five of 22 children in the tympanostomy tube group failed, compared to 12 of 20 in the placebo group (p = .02). There were 8 or 21 treatment failures in the sulfisoxazole group. Children with otitis media with effusion (OME) at the time of their initial visit had significantly less middle ear disease when treated with tympanostomy tubes. Tympanostomy tube insertion for prophylaxis of recurrent acute otitis is supported by these findings. Improvement of recurrent AOM was observed in the sulfisoxazole group, but was not statistically significant.

RCT Entities:   Population Interventions Outcomes