Effectiveness of ototopical antibiotics for chronic suppurative otitis media in Aboriginal children: a community-based, multicentre, double-blind randomised controlled trial

Med J Aust. 2003 Aug 18;179(4):185-90.

Abstract

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Topical
  • Adolescent
  • Anti-Infective Agents / administration & dosage*
  • Child
  • Child, Preschool
  • Chronic Disease
  • Ciprofloxacin / administration & dosage
  • Community Health Services
  • Dexamethasone / administration & dosage
  • Drug Administration Schedule
  • Female
  • Framycetin / administration & dosage
  • Gramicidin / administration & dosage
  • Humans
  • Infant
  • Male
  • Oceanic Ancestry Group
  • Otitis Media, Suppurative / drug therapy*
  • Otitis Media, Suppurative / pathology
  • Povidone-Iodine / administration & dosage
  • Queensland
  • Treatment Outcome
  • Western Australia

Substances

  • Anti-Infective Agents
  • Gramicidin
  • Framycetin
  • Ciprofloxacin
  • Dexamethasone
  • Povidone-Iodine