Acute tympanostomy tube otorrhea.
Conditions
Interventions
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.
Sponsors
- Wilhelmina Children's Hospital
- Julius Center for Health Sciences and Primary Care
University Medical Center Utrecht
Eligibility
Inclusion criteria
Inclusion criteria: 1. All children aged 1 to 10 years developing otorrhea after insertion of tympanostomy tubes.
Exclusion criteria
Exclusion criteria: 1. Having had tympanostomy tubes inserted within the preceding 2 weeks; 2. Having used systemic or ototopical antibiotics within the preceding 2 weeks; 3. Having had a period of tympanostomy tube otorrhea within the preceding 2 weeks; 4. Having had ear discharge for more than one week; 5. Known allergy to hydrocortison-bacitracine-colistine ear drops or amoxicillin-clavulanic acid; 6. Down syndrome; 7. Cleft palate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Otoscopic signs of otorrhea at the scheduled follow-up visit at 2 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Episodes and days of otorrhea according to the parents (diary); 2. Adverse effects of the study medication (diary); 3. Complications (diary); 4. Microbiology of the otorrhea samples; 5. Health-related quality of life (at baseline and scheduled follow-up visits); 6. Cost-effectiveness. | — |
Contacts
Public ContactAnne G.M. Schilder
University Medical Center Utrecht Wilhelmina Children's Hospital Department of Otorhinolaryngology PO Box 85090
Outcome results
None listed