Pediatric Pearls: Treatment for Recurrent Ear Infections

The Research

In this randomized trial of tympanostomy tube placement vs medical management, one of the preeminent otitis media research groups in the United States evaluated 250 children aged between 6 and 35 months who had had at least 3 episodes of otitis media in the prior 3 months or 4 episodes in the prior year. The patients were randomly assigned to 1 of 2 groups: one scheduled for tympanostomy tube placement and the other for management with antibiotics to treat recurrences of otitis media. The patients were followed for 2 years, comparing the incidence of new episodes of acute otitis media.

The Results

The authors found that the mean number of episodes of otitis media over the next 2 years was 1.48 episodes in children in the tympanostomy group and 1.56 episodes in children in the antibiotics group. They concluded that in children aged between 6 and 35 months, the number of episodes of otitis media was not lower in a group of patients assigned to tympanostomy tube placement than in a group assigned to medical management alone.

In an accompanying editorial,4 Ellen Wald, a former colleague of the authors in Pittsburgh, points out the strengths of the study—the rigorous inclusion criteria for acute otitis media—and the weaknesses; most prominently, the researchers randomly assigned only 250 patients, and 45% of those randomly assigned to medical management ended up with tubes, either because of treatment failure of medical management or parental preference. She concluded that the study was underpowered to draw appropriate conclusions about the equivalence of medical management and tube placement and recommended a discussion of risks and benefits of both approaches with every family.

What’s the Take Home?

Although this study represents a significant contribution to the literature on tympanostomy tube placement, I agree with Ellen Wald. Due to the modest sample size and the reassignment of patients—children in the tympanostomy tube group who did not undergo surgery and children in the antibiotics group who did—I believe that further study is needed before a more definitive conclusion can be drawn regarding the indication for tube placement to decrease the incidence of recurrent acute otitis media. I plan to continue to offer referral to the parents and guardians of my patients who have more than 3 new episodes of acute otitis media in 6 months or 4 in a year, as well as for those in whom persistent serous fluid (otitis media with effusion) is present for longer than 3 months.

Reference:

1. Hoberman A, Preciado D, Paradise JL, et al. Tympanostomy tubes or medical management for recurrent acute otitis media. N Engl J Med. 2021;384(19):1789-1799. https://doi.org/10.1056/nejmoa2027278

Scott T. Vergano, MD, is a pediatrician in the Department of Pediatrics, Children’s Hospital of the King’s Daughters, Norfolk Virginia.