Many children get tympanostomy tubes placed in their ears to prevent recurrent acute otitis media or to restore hearing after otitis media with effusion. While helpful, these tubes can introduce problems of their own. A common complication is acute otorrhea, a condition marked by fevers, foul drainage, and significant pain and discomfort. Because otorrhea is thought to stem from acute otitis media, which in turn is primarily caused by bacterial infection of the middle ear, the goal of treatment is to eliminate infection. But what is the best way to do so?
This week in NEJM, van Dongen et al. report findings from a randomized controlled trial that compared three approaches to treatment: antibiotic-glucocorticoid ear drops, oral antibiotics, and initial observation. The study enrolled 230 children ages 1 to 10 years with tympanostomy tubes who had displayed up to a week’s duration of otorrhea symptoms. The children were randomized to receive either a week of hydrocortisone–bacitracin–colistin ear drops, a week of oral amoxicillin–clavulanate, or two weeks of observation. The primary outcome was the presence of otorrhea in one or both ears after two weeks. Secondary outcomes included the duration of the initial otorrhea episode following study assignment and the total number of days with otorrhea during six months of follow-up.
For the outcomes tested, antibiotic-steroid eardrops were found to be superior to both oral antibiotics and observation. Only 5% of children treated with the eardrops developed otorrhea, as compared to 44% of children receiving oral antibiotics and 55% of those assigned to observation. The risk difference between children receiving oral antibiotics versus observation was not significant.
The duration of the initial otorrhea episode was shorter with eardrops (4 days) than with oral antibiotics (5 days; P<0.001) or observation (12 days; P<0.001). The total number of days of otorrhea during the six months of follow-up was also lower with eardrops (5 days) as compared to oral antibiotics (13.5 days) or observation (18 days) (P<0.001).
These findings suggest antibiotic-steroid eardrops may be preferable for treating acute otorrhea. Observation alone did not seem to be a desirable option; more than half of the children assigned to the observation arm still had otorrhea at two weeks.
NEJM Deputy Editor Dr. Lindsey Baden states: “It is important to develop strategies to decrease complications in the treatment of recurrent otitis media, a common infection in childhood. This randomized trial provides evidence to guide clinicians.”
Further studies may be warranted to test the safety and efficacy of different types of eardrops and antibiotics, but these results offer valuable insight to the doctors and parents of children with tympanostomy tubes: when it comes to treatment options for acute otorrhea, it seems there is a clear winner.
How common is acute otorrhea among your patients with tympanostomy tubes? How do you currently manage it? Are these study findings consistent with the effectiveness of treatment options you have observed in your practice?