N. Engl. J. Med 2014 Feb 20;370(8)723-733, TMA van Dongen, GJMG van der Heijden, RP Venekamp, MM Rovers, AGM Schilder
Research · February 28, 2014
TAKE-HOME MESSAGE
- This open-label study of 230 children who had acute tympanostomy-tube otorrhea compared outcomes in patients randomized to immediate treatment with either antibiotic–glucocorticoid eardrops or oral antibiotics and initial observation. Antibiotic–glucocorticoid eardrops were significantly better than oral antibiotics and observation. At 2 weeks, only 5% of children treated with drops still had ear infection vs 44% on oral antibiotics and 55% assigned to observation. Median duration of otorrhea was 4 days, 5 days, and 12 days, respectively. Initial observation led to more days with otorrhea in subsequent months compared with drops or oral antibiotics.
- The results suggest that initial observation is inadequate treatment for children who have tympanostomy tubes and otorrhea, with antibiotic–glucocorticoid eardrops being the superior treatment approach for uncomplicated infection.
Commentary By: David Rakel MD, FAAFP
In this open-label, pragmatic trial, 230 children in the Netherlands with tympanostomy-tube otorrhea were randomized to three groups: topical antibiotic–glucocorticoid drops; oral amoxicillin–clavulanate suspension; or observation. At 2 weeks, the topical treatment group had a 5% rate of otorrhea compared with 44% taking the oral antibiotic and 55% in the observation group. There was an equal incidence of side effects in both treatment groups, with the drops causing pain and the oral antibiotic causing gastrointestinal distress in 21% and 23%, respectively.
The eardrop used contained hydrocortisone–bacitracin–colistine (Bacicoline-B) and was given as five drops three times daily in the discharging ear for 7 days. Unfortunately, this product is not available in the United States. A comparable product that is available that would have similar coverage is a combination of ciprofloxacin and dexamethasone (Ciprodex) given four drops in discharging ear twice daily for 7 days. A previous study using ciprofloxacin drops without the steroid was not as effective.1
In this trial, the ear was not cleaned out before placing the drops. So, don’t feel that you have to hold down a resistant child to do this before treatment.
Reference
Heslop A, Lildholdt T, Gammelgaard N, Ovesen T, et al. Topical ciprofloxacin is superior to topical saline and systemic antibiotics in the treatment of tympanostomy tube otorrhea in children: the results of a randomized clinical trial. Laryngoscope. 2010;120(12):2516-2520.
ABSTRACT
BACKGROUND
Recent guidance for the management of acute otorrhea in children with tympanostomy tubes is based on limited evidence from trials comparing oral antibiotic agents with topical antibiotics.
METHODS
In this open-label, pragmatic trial, we randomly assigned 230 children, 1 to 10 years of age, who had acute tympanostomy-tube otorrhea to receive hydrocortisone–bacitracin–colistin eardrops (76 children) or oral amoxicillin–clavulanate suspension (77) or to undergo initial observation (77). The primary outcome was the presence of otorrhea, as assessed otoscopically, 2 weeks after study-group assignment. Secondary outcomes were the duration of the initial otorrhea episode, the total number of days of otorrhea and the number of otorrhea recurrences during 6 months of follow-up, quality of life, complications, and treatment-related adverse events.
RESULTS
Antibiotic–glucocorticoid eardrops were superior to oral antibiotics and initial observation for all outcomes. At 2 weeks, 5% of children treated with antibiotic–glucocorticoid eardrops had otorrhea, as compared with 44% of those treated with oral antibiotics (risk difference, −39 percentage points; 95% confidence interval [CI], −51 to −26) and 55% of those treated with initial observation (risk difference, −49 percentage points; 95% CI, −62 to −37). The median duration of the initial episode of otorrhea was 4 days for children treated with antibiotic–glucocorticoid eardrops versus 5 days for those treated with oral antibiotics (P<0.001) and 12 days for those who were assigned to initial observation (P<0.001). Treatment-related adverse events were mild, and no complications of otitis media, including local cellulitis, perichondritis, mastoiditis, and intracranial complications, were reported at 2 weeks.
CONCLUSIONS
Antibiotic–glucocorticoid eardrops were more effective than oral antibiotics and initial observation in children with tympanostomy tubes who had uncomplicated acute otorrhea.
The New England Journal of Medicine
A Trial of Treatment for Acute Otorrhea in Children With Tympanostomy Tubes
N. Engl. J. Med 2014 Feb 20;370(8)723-733, TMA van Dongen, GJMG van der Heijden, RP Venekamp, MM Rovers, AGM Schilder