title: A trial of treatment for acute otorrhea in children with tympanostomy tubes.
abstract: 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 antibiotic-glucocorticoid eardrops had otorrhea, as compared with 44% of those treated with oral antibiotics (risk difference, -39 percentage points; 95% confidence interval [CI], -51 to -26) and 55% of those treated with initial observation (risk difference, -49 percentage points; 95% CI, -62 to -37). The median duration of the initial episode of otorrhea was 4 days for children treated with antibiotic-glucocorticoid eardrops versus 5 days for those treated with oral antibiotics (P<0.001) and 12 days for those who were assigned to initial observation (P<0.001). Treatment-related adverse events were mild, and no complications of otitis media, including local cellulitis, perichondritis, mastoiditis, and intracranial complications, were reported at 2 weeks.
  
  
  CONCLUSIONS
  Antibiotic-glucocorticoid eardrops were more effective than oral antibiotics and initial observation in children with tympanostomy tubes who had uncomplicated acute otorrhea. (Funded by the Netherlands Organization for Health Research and Development; Netherlands Trial Register number, NTR1481.).
authors.affiliation: From the Department of Epidemiology, Julius Center for Health Sciences and Primary Care (T.M.A.D., G.J.M.G.H., R.P.V., M.M.R., A.G.M.S.), and the Department of Otorhinolaryngology, Division of Surgical Specialties (G.J.M.G.H., R.P.V., A.G.M.S.), University Medical Center Utrecht, Utrecht, the Department of Social Dentistry, Academic Center for Dentistry Amsterdam, University of Amsterdam and VU University Amsterdam, Amsterdam (G.J.M.G.H.), and the Departments of Operating Rooms and Health Evidence, Radboud University Medical Center, Nijmegen (M.M.R.) - all in the Netherlands; and the Ear Institute, University College London, London (A.G.M.S.).
authors.forename: Thijs M A
authors.initials: TM
authors.lastname: van Dongen
authors.forename: Geert J M G
authors.initials: GJ
authors.lastname: van der Heijden
authors.forename: Roderick P
authors.initials: RP
authors.lastname: Venekamp
authors.forename: Maroeska M
authors.initials: MM
authors.lastname: Rovers
authors.forename: Anne G M
authors.initials: AG
authors.lastname: Schilder
mesh_terms: D000284:Administration, Oral; D000287:Administration, Topical; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000008:administration & dosage; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001414:Bacitracin / Q000008:administration & dosage; D002648:Child; D002675:Child, Preschool; D003091:Colistin / Q000008:administration & dosage; D004338:Drug Combinations; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D006854:Hydrocortisone / Q000008:administration & dosage; D007223:Infant; D053208:Kaplan-Meier Estimate; D008297:Male; D008876:Middle Ear Ventilation / Q000009:adverse effects*; D010034:Otitis Media with Effusion / Q000188:drug therapy* / Q000209:etiology / Q000601:surgery
chemical_list: D000900:Anti-Bacterial Agents; D004338:Drug Combinations; D005938:Glucocorticoids; D001414:Bacitracin; D019980:Amoxicillin-Potassium Clavulanate Combination; D006854:Hydrocortisone; D003091:Colistin