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

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.

• Authors: Sophie Couzos, Traven Lea, Reinhold Mueller, Richard Murray, Margaret Culbong
• Journal: The Medical journal of Australia (Med J Aust) Vol. 179 Issue 4 Pg. 185-90 (Aug 18 2003) ISSN: 0025-729X [Print] Australia
• PMID: 12914507 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

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

Topics

• 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
• Native Hawaiian or Other Pacific Islander
• Otitis Media, Suppurative (drug therapy, pathology)
• Povidone-Iodine (administration & dosage)
• Queensland
• Treatment Outcome
• Western Australia