'Comparison of ototopical antibiotic-steroid drops or oral antibiotics versus watchful waiting in children with acute tympanostomy tube otorrhea'

Background:

Otorrhea is the most common complication in children with tympanostomy tubes in place.

In the Netherlands, each year about 10,000 children suffer from tympanostomy tube otorrhea (TTO). It causes discomfort to the child and is a cause of concern to its parents. Current management of TTO exists of ototopical antibiotic-steroid drops, oral antibiotics or watchful waiting. Empirical evidence regarding the cost-effectiveness of these approaches is lacking.

Research questions:

1. What is the effectiveness of oral antibiotics versus ototopical antibiotic-steroid drops versus watchful waiting in children with acute TTO in terms of otoscopic signs of otorrhea, days with ear discharge, recurrent episodes of TTO, adverse effects, and quality of life?

2. What is the relation between costs and effects of these interventions?


Study design:
Pragmatic multicenter randomized trial with a follow-up of 6 months.


Study population:
315 children aged 1 to 10 years developing otorrhea as from 2 weeks after insertion of tympanostomy tubes.


Intervention:
1) hydrocortison-bacitracine-colistine (Bacicoline-B) ear drops (3dd 5 drops for 7 days);
2) amoxicillin-clavulanic acid (30-7.5 mg/kg in 3dd to be taken orally for 7 days); 3) watchful waiting.


Primary outcome measure:
Otoscopic signs of otorrhea at 2 weeks follow-up.


Secondary outcome measures:
Episodes and days of otorrhea, health-related quality of life, adverse effects of study medication, complications, microbiology of otorrhea samples, and cost-effectiveness.

Data-analysis:
The effects of watchful waiting versus ototopical antibiotic drops versus oral antibiotics
will be calculated as risk differences and risk ratios with 95% confidence intervals. Kaplan Meier curves for duration of ear discharge will be plotted, and differences tested with a log rank test. Quality of life data will be analyzed with analyses of variance (ANOVA). All analyses will be performed on an
intention-to-treat basis.


Economic evaluation:
Incremental cost-effectiveness ratios (iCERs) with 95% confidence intervals will be calculated, i.e. the costs for society to treat the number of patients needed to clinically cure one patient.


Time schedule:
February 2009-January 2011; 36 months.

Current management of tympanostomy tube otorrhea includes ototopical antibiotic-steroid drops, oral antibiotics or watchful waiting. Empirical evidence regarding the cost-effectiveness of these approaches is lacking.

February 2009 - January 2012; 36 months.

Children whose parents have given informed consent will be randomly assigned to either:

1) Hydrocortison-bacitracine-colistine (Bacicoline-B) ear drops (3dd 5 drops for 7 days);

2)
Amoxicillin-clavulanic acid (30-7.5 mg/kg in 3dd to be taken orally for 7 days); 3) watchful waiting.