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.


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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.

References

  1. Van Dongen TMA et al. N Engl J Med. 2014; 370: 723-733.