Topical Ciprofloxacin/Dexamethasone is Superior to Ciprofloxacin Alone in Pediatric Patients with Acute Otitis Media and Otorrhea through Tympanostomy Tubes

Peter S. Roland, Jack B. Anon, Richard D. Moe, Peter J. Conroy, G. Michael Wall, Sheryl J. Dupre, Kimberly A. Krueger, Susan Potts, Gail Hogg, David W. Stroman

Research output: Contribution to journalArticlepeer-review

59 Scopus citations

Abstract

Objective: To determine whether topical administration of a corticosteroid improves resolution of acute tympanostomy tube otorrhea when combined with topical antibiotic drops. Study Design: Randomized, patient-masked, parallel-group, multicenter trial of topical otic ciprofloxacin/dexamethasone versus topical ciprofloxacin alone in 201 children aged 6 months to 12 years with acute otitis media with tympanostomy tubes (AOMT) of less than or equal to 3 weeks' duration and visible otorrhea. Methods: Eligible patients were randomized to receive three drops of either ciprofloxacin 0.30%/dexamethasone 0.1% or ciprofloxacin 0.3% into the affected ear or ears twice daily for 7 days. Clinical signs and symptoms of AOMT were evaluated on days 1 (baseline), 3, 8 (end-of-therapy), and 14 (test-of-cure), and twice-daily assessments of otorrhea were recorded in patient diaries. Results: The mean time to cessation of otorrhea in the microbiologically culture-positive patient population (n = 167) was significantly shorter with topical ciprofloxacin/dexamethasone than with ciprofloxacin alone (4.22 vs. 5.31 days; P = .004). This resulted in significantly better clinical responses on days 3 and 8 (P < .0001 and P =.0499, respectively). However, there were no significant differences between the two treatment groups in either the clinical response or the microbial eradication rate by day 14. Conclusions: Topical otic treatment with ciprofloxacin/dexamethasone is superior to treatment with ciprofloxacin alone and results in a faster clinical resolution in children with AOMT. The contribution of the cortico-steroid in achieving a 20% reduction (1.1 day) in time to cessation of otorrhea is clinically meaningful and represents an important advance over single-agent antibiotic therapy.

Original languageEnglish (US)
Pages (from-to)2116-2122
Number of pages7
JournalLaryngoscope
Volume113
Issue number12
DOIs
StatePublished - Dec 1 2003

Keywords

  • Acute otitis media
  • Ciprofloxacin
  • Dexamethasone
  • Otorrhea
  • Tympanostomy tubes

ASJC Scopus subject areas

  • Otorhinolaryngology

Fingerprint Dive into the research topics of 'Topical Ciprofloxacin/Dexamethasone is Superior to Ciprofloxacin Alone in Pediatric Patients with Acute Otitis Media and Otorrhea through Tympanostomy Tubes'. Together they form a unique fingerprint.

Cite this