After Ear Tubes: Eardrops Found Superior to Oral Antibiotics for Ear Discharge

Dr. T. M. A van Dongen, MD Univ Med Ctr Utrecht Julius Ctr Hlth Sci & Primary Care, Dept Epidemiol Utrecht, Netherlands. Interview with:
Dr. T. M. A van Dongen, MD

Univ Med Ctr Utrecht
Julius Ctr Hlth Sci & Primary Care, Dept Epidemiol
Utrecht, Netherlands. What are the main findings of the study?

Answer: We performed a pragmatic trial, in which we randomly assigned 230 children who had acute tympanostomy-tube otorrhea to receive antibiotic-glucocorticoid eardrops, oral antibiotics or to undergo initial observation. The primary outcome of our study was the presence of ear discharge, 2 weeks after study-group assignment. We also looked at, among others, the duration of the initial otorrhea episode and the total number of days of otorrhea and the number of otorrhea recurrences during 6 months of follow-up. We found that antibiotic–glucocorticoid eardrops were superior to oral antibiotics and initial observation for all outcomes. Were any of the findings unexpected?

Answer: Since acute tympanostomy-tube otorrhea, like acute otitis media, can be self-limiting, initial observation was thought by some to be a good alternative for antibiotic treatment. We are the first to compare the effectiveness of oral or topical treatment with initial observation. Approximately one in two children managed by initial observation still had otorrhea at 2 weeks and initial observation resulted in more days with otorrhea in the following months than did topical or oral antibiotics. So our results actually suggest that initial observation is not an adequate management strategy in such children. What should clinicians and patients take away from your report?


· Standard patient information usually advises parents to contact a physician when their child’s symptoms of tube otorrhea persist for more than a week. At that stage, so when parents contact a physician, recommendations from clinical practice guidelines vary widely: some advise physicians to manage with oral antibiotics or more observation, while others suggest prescribing antibiotic eardrops. We recommend updating current patient information and clinical practice guidelines. Our results show it’s best to inform parents to contact a physician when otorrhea occurs, rather than waiting for a week or more to see if otorrhea abates without treatment. In addition, we recommend physicians to treat these children with eardrops shortly after onset of symptoms. What recommendations do you have for future research as a result of this study?

Answer: For many years, the use of topical antibiotics in children with acute tympanostomy-tube otorrhea has been questioned for their presumed inability to reach the middle ear. In vivo studies in children with a ‘clean’ ear canal and patent tympanostomy tube as well as in vitro studies reported low rates of spontaneous penetration of eardrops into the middle ear. These studies raised even more doubt about eardrops reaching the middle ear in children with active tube otorrhea. Yet our study of children with middle ear fluid visibly draining through the tympanostomy tube into the ear canal showed that eardrops were highly effective, indicating that its active components do reach the site of infection. As such, one could therefore question whether antibiotic(-glucocorticoid) eardrops may also be effective in children without tubes who develop acute otitis media and present with spontaneous otorrhea. So far, this has not been evaluated in a randomized clinical trial, presumably based upon the same rationale, i.e. that the eardrops would not reach the infected middle ear. Since topical treatment is usually well tolerated, causes no systemic side effects and is less likely to cause antimicrobial resistance as compared to oral antibiotics, a trial of the effectiveness of topical antibiotics versus oral antibiotics in children with acute otitis media presenting with spontaneous otorrhea seems warranted.


A Trial of Treatment for Acute Otorrhea in Children with Tympanostomy Tubes
hijs M.A. van Dongen, M.D., Geert J.M.G. van der Heijden, Ph.D., Roderick P. Venekamp, M.D., Ph.D., Maroeska M. Rovers, Ph.D., and Anne G.M. Schilder, M.D., Ph.D.

N Engl J Med 2014; 370:723-733
February 20, 2014DOI: 10.1056/NEJMoa1301630