Topical ciprofloxacin/dexamethasone otic suspension is superior to ofloxacin otic solution in the treatment of granulation tissue in children with acute otitis media with otorrhea through tympanostomy tubes.

Author(s): Roland PS, Dohar JE, Lanier BJ, Hekkenburg R, Lane EM, Conroy PJ, Wall GM, Dupre SJ, Potts SL, CIPRODEX AOMT Study Group

Affiliation(s): Department of Otolaryngology, University of Texas Southwestern Medical Center, Dallas, TX 75390-9035, USA. Peter.Roland@UTSouthwestern.edu

Publication date & source: 2004-06, Otolaryngol Head Neck Surg., 130(6):736-41.

Publication type: Clinical Trial; Randomized Controlled Trial

OBJECTIVE: Comparison of topical ciprofloxacin/dexamethasone otic suspension (CIP/DEX) to ofloxacin otic solution (OFL) for treatment of granulation tissue in children with AOMT. STUDY DESIGN: 599 children aged >/=6 months to 12 years with AOMT of up to 3 weeks' duration were enrolled. Patients received either CIP/DEX 4 drops twice daily for 7 days or OFL 5 drops twice daily for 10 days. Granulation tissue severity was graded at clinic visits on days 1, 3, 11, and 18. RESULTS: Granulation tissue was present in 90 of 599 AOMT patients (15.0%) at baseline. CIP/DEX treatment was superior to OFL for reduction of granulation tissue at the day 11 visit (81.3% compared with 56.1%, P = 0.0067) and the day 18 visit (91.7% compared with 73.2%, P = 0.0223). Both topical otic preparations are safe and well tolerated in pediatric patients. CONCLUSION: CIP/DEX was superior to OFL in the treatment of granulation tissue in children with AOMT.