Tube associated otorrhea in children with recurrent acute otitis media; results of a prospective randomized study on bacteriology and topical treatment with or without systemic antibiotics

Abstract

To establish if otorrhea associated to tympanostomy tubes in infants suffering from recurrent acute otitis media is similar to acute otitis media, and if topical treatment alone is sufficient or if addition of systemic antibiotics is required. Children under 3 years of age with tympanostomy tubes due to recurrent acute otitis media were recruited to the study. The study design was open label randomized and prospective. Fifty patients were allocated to either of two treatment groups and were monitored for 6 months. Group I received only topical treatment (commercially available ear drops and saline solution) in case of otorrhea. Group II was treated with topical treatment together with systemic antibiotics. All episodes of acute otorrhea were registered. Main outcome measure was duration of otorrhea in days. Bacterial samples from the ear discharge were taken. Forty-one episodes were treated according to protocol. The bacteriological testing mainly showed bacteria typical of acute otitis media. A majority of episodes were cured within 7 days in both groups, and statistical analysis showed no significant difference between the treatment groups in duration of otorrhea. In Group I systemic antibiotics were added in one-third (7/21) of the episodes due to signs of affected general condition such as high fever and severe earache. The otorrhea episodes in the study were similar to acute otitis media based on the bacteriological results. Topical treatment alone might be used as first treatment of choice. Although systemic antibiotics were added in several cases in the topical treatment group, the findings of the study do not support use of systemic antibiotics for tube associated otorrhea in RAOM children in general.