HealthDay News — Children with acute tympanostomy-tube otorrhea have significantly better outcomes after treatment with antibiotic-glucocorticoid eardrops compared with oral antibiotics or initial observation, according to researchers.
In an open-label randomized trial hydrocortisone-bacitracin-colistin eardrops cleared the discharge within two weeks in 95% of children with tympanostomy tubes,Thijs van Dongen, MD, of the University Medical Center Utrecht in the Netherlands and colleagues reported in New England Journal of Medicine.
In contrast, an oral amoxicillin-clavulanate suspension was successful in just 66% of children with acute tympanostomy-tube otorrhea and initial observation was successful in 45% of children, the researchers found.
They randomly assigned 230 children aged 1 to 10 years who had acute tympanostomy-tube otorrhea to treatment with either hydrocortisone-bacitracin-colistin eardrops, oral amoxicillin-clavulanate suspension or initial observation.
The primary outcome was the continued presence of otorrhea assessed otoscopically after 2 weeks, but the investigators also looked at duration of the initial otorrhea episode, total number of days of otorrhea, and the number of otorrhea recurrences during a 6 month follow-up period.
After two weeks, children treated with antibiotic-glucocorticoid eardrops had significantly better outcomes. A smaller percentage of these children had otorrhea — 5% vs. 44% for oral antibiotics (relative risk 0.12, 95% CI: 0.05-0.33) and 55% for observation (RR 0.09, 95% CI: 0.03-0.24).
The median duration of otorrhea was four days for the antibiotic-glucocorticoid eardrop group, five days for the oral antibiotic group and 12 days for the observation group (P<0.001 for all). Only mild treatment-related adverse events were observed and no complications of otitis media were reported.
“Antibiotic-glucocorticoid eardrops were more effective than oral antibiotics and initial observation in children with tympanostomy tubes who had uncomplicated acute otorrhea,” van Dongen and colleagues conclude.