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Acute otorrhea from otitis media is a common complication of tympanostomy tubes. In a randomized open-label study, researchers in Europe compared the effectiveness of oral amoxicillin-clavulanate suspension (3 doses daily for 1 week), eardrops containing hydrocortisone-bacitracin-colistin (5 drops, 3 times daily for 1 week), or 2 weeks of observation in 230 children (age range,1–10 years) with symptoms of tympanostomy-tube otorrhea.
At 2 weeks, only 5% of children treated with eardrops had otorrhea, compared with 44% in the oral antibiotic group and 55% in the observation group (number needed to treat, 3 and 2, respectively). The median duration of the initial episode of otorrhea was significantly shorter with eardrops than with oral antibiotics (4 vs. 5 days) or in the observation group (12 days). During 6 months of follow-up, median number of days with otorrhea was 5 versus 13 and 15 days, respectively. Twenty-one percent of children receiving eardrops had pain or discomfort when drops were administered, and 23% of children receiving oral antibiotics had gastrointestinal symptoms. Quality-of-life score did not differ significantly among the groups.
van Dongen TMA et al. A trial of treatment for acute otorrhea in children with tympanostomy tubes. N Engl J Med 2014 Feb 20; 370:723. (http://dx.doi.org/10.1056/NEJMoa1301630)
Comment
Eardrops with a combination of antibiotics and hydrocortisone were the most effective treatment for acute otorrhea in children with tympanostomy tubes. This combination of agents in eardrops is not currently approved by the FDA. However, a ciprofloxacin and dexamethasone suspension (Ciprodex) has also been shown to be effective for this indication and is FDA approved for use in children aged 6 months and older (JW Pediatr Adolesc Med Oct 4 2006). Careful cleaning of the ear canal is necessary for ear drops to be effective in the middle ear.