A trial of treatment for acute otorrhea in children with tympanostomy tubes.

Background Recent guidance for the management of acute otorrhea in children with tympanostomy tubes is based on limited evidence from trials comparing oral antibiotic agents with topical antibiotics. Methods In this open-label, pragmatic trial, we randomly assigned 230 children, 1 to 10 years of age, who had acute tympanostomy-tube otorrhea to receive hydrocortisone–bacitracin–colistin eardrops (76 children) or oral amoxicillin–clavulanate suspension (77) or to undergo initial observation (77). The primary outcome was the presence of otorrhea, as assessed otoscopically, 2 weeks after study-group assignment. Secondary outcomes were the duration of the initial otorrhea episode, the total number of days of otorrhea and the number of otorrhea recurrences during 6 months of follow-up, quality of life, complications, and treatment-related adverse events. Results Antibiotic–glucocorticoid eardrops were superior to oral antibiotics and initial observation for all outcomes. At 2 weeks, 5% of children treated with ...