None listed
Conditions
Brief summary
Chronic suppurative otitis media (CSOM) is the most severe form of middle ear disease, characterised by a hole in the eardrum, though which discharge drains (for longer than two weeks). CSOM disproportionally impacts children living in low socioeconomic conditions, including remote-living First Nations children. This trial will compare topical hydrogen peroxide followed by topical ciprofloxacin with ciprofloxacin alone to manage CSOM that has failed to resolve with standard treatment.
Interventions
1-3mls (5 drops) of 3% hydrogen peroxide (diluted in water) twice daily, in addition to standard treatment (ear cleaning and topical 5 drops of 0.3% ciprofloxacin hydrochloride drops two-three times daily), administered by parents/carers for up to 8 weeks (or until the ear is dry for three consecutive days). Diary recording methods will be supported.
Sponsors
Menzies School of Health Research
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
1 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
Unilateral or bilateral persistent or recurrent CSOM, including discharge through a tympanostomy tube. CSOM will be defined as discharge for more than 2 weeks through a hole in the eardrum of greater than 2% of the pars tensa (main part of the ear drum) or through a tympanostomy tube. Persistent CSOM will be defined as ongoing discharge despite at least 4 weeks of recommended treatment. Recurrent CSOM will be defined as recurrence of discharge (3 or more episodes within 6 months).
Exclusion criteria
- Previous randomisation - Known allergy or skin reaction (inflammation or rash) to either ciprofloxacin or hydrogen peroxide - Recent (within 6 months, excluding tympanostomy tube insertion) or scheduled ear surgery within 3 months
Outcome results
None listed