Acute Otorrhea in Kids With Tympanostomy Tubes: Which Treatment Is Best?

William T. Basco, Jr., MD, MS


May 09, 2014

A Trial of Treatment for Acute Otorrhea in Children With Tympanostomy Tubes

Van Dongen TM, van der Heijden GJ, Venekamp RP, Rovers MM, Schilder AG
N Engl J Med. 2014;370:723-733

Study Summary

Otorrhea occurs commonly in children with tympanostomy tubes and is considered to represent an acute infectious episode akin to acute otitis media. This trial sought to overcome limitations of previous studies that compared otic vs oral therapy for otorrhea by enrolling more children than in previous studies and by including an intitial observation group. Children in the treatment groups received immediate treatment with antibiotic-glucocorticoid ear drops or oral antibiotics.

The children were aged 1-10 years, and all had tympanostomy tubes and otorrhea of 7 or fewer days at the time of enrollment. These children were afebrile and had not received recent antibiotics or recent placement of their tympanostomy tubes. The children were enrolled from 2009 through 2012 in several clinics at a single institution. Enrollment included a home visit for informed consent, confirmation of physical findings, and obtaining samples for bacteriologic culture. The children were randomly assigned to the 3 study groups on a 1:1:1 ratio. The otic treatment group (n = 76) received a drug that contained hydrocortisone, bacitracin, and colistin, dosed as 5 drops 3 times daily for 7 days. The oral antibiotic group (n = 77) received amoxicillin-clavulanate at 30 mg/kg of amoxicillin, divided into 3 daily doses for 7 days. Children in the observation group (n = 77) were observed for 2 weeks. All families were asked to maintain a daily diary of treatment adherence, adverse events, and complications; they were also asked to participate in a follow-up home visit that included an otoscopic exam at 2 weeks and 6 months.

The primary outcome was the presence of otorrhea at the 2-week observation point, with treatment failure defined as persistent otorrhea. There was also a follow-up at 6 months postenrollment. Secondary outcomes included duration of otorrhea and the number of otorrhea episodes during the 6-month follow-up. The researchers initially planned to enroll 315 children, but the trial was stopped when only 230 children were enrolled because of a striking difference in outcomes among the groups.


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