Premium
Effectiveness of ototopical antibiotics for chronic suppurative otitis media in Aboriginal children: a community‐based, multicentre, double‐blind randomised controlled trial
Author(s) -
Couzos Sophie,
Lea Traven,
Culbong Margaret,
Mueller Reinhold,
Murray Richard
Publication year - 2003
Publication title -
medical journal of australia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.904
H-Index - 131
eISSN - 1326-5377
pISSN - 0025-729X
DOI - 10.5694/j.1326-5377.2003.tb05496.x
Subject(s) - chronic suppurative otitis media , medicine , ciprofloxacin , randomized controlled trial , otitis , pediatrics , antibiotics , surgery , microbiology and biotechnology , biology
Objectives: To compare the effectiveness of ototopical ciprofloxacin (0.3%; CIP) with framycetin (0.5%), gramicidin, dexamethasone (FGD) eardrops (5 drops twice daily for 9 days) together with povidone‐iodine (0.5%) ear cleaning as treatments for chronic suppurative otitis media (CSOM) in Aboriginal children. Design and participants: Aboriginal community‐controlled, community‐based, multicentre, double‐blind, randomised controlled trial in eight Aboriginal Community Controlled Health Services across northern Australia, involving 147 Aboriginal children with CSOM. Main outcome measures: Resolution of otorrhoea (clinical cure), proportion of children with healed perforated tympanic membrane (TM) and improved hearing, 10–21 days after starting treatment. Results: 111 children aged 1–14 years (CIP, 55; FGD, 56) completed treatment. CSOM cures occurred in 64% (CIP, 76.4%; FGD, 51.8%), with a significantly higher rate in the ciprofloxacin group ( P = 0.009, absolute difference of 24.6% [95% CI, 15.8%–33.4%]). TM perforation size and the level of hearing impairment did not change. Pseudomonas aeruginosa was the most common bacterial pathogen (in 47.6%), while respiratory pathogens were rare (in 5.7%). Conclusions: Twice‐daily ear cleaning and topical ciprofloxacin is effective at community‐level in achieving cure for CSOM. Healthcare providers to Aboriginal children with CSOM should be given special access to provide ototopical ciprofloxacin as first‐line treatment.