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

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...

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Bibliographic Details
Published in:	The Laryngoscope Vol. 113; no. 12; pp. 2116 - 2122
Main Authors:	Roland, Peter S., Anon, Jack B., Moe, Richard D., Conroy, Peter J., Wall, G. Michael, Dupre, Sheryl J., Krueger, Kimberly A., Potts, Susan, Hogg, Gail, Stroman, David W.
Format:	Journal Article
Language:	English
Published:	Hoboken, NJ John Wiley & Sons, Inc 01-12-2003 Wiley-Blackwell
Subjects:	Acute Disease acute otitis media Administration, Topical Antibacterial agents Antibiotics. Antiinfectious agents. Antiparasitic agents Biological and medical sciences Cerebrospinal Fluid Otorrhea - drug therapy Cerebrospinal Fluid Otorrhea - microbiology Child Child, Preschool Ciprofloxacin Ciprofloxacin - administration & dosage Ciprofloxacin - adverse effects dexamethasone Dexamethasone - administration & dosage Dexamethasone - adverse effects Drug Therapy, Combination Ear, auditive nerve, cochleovestibular tract, facial nerve: diseases, semeiology Female Humans Infant Male Medical sciences Middle Ear Ventilation - adverse effects Non tumoral diseases Otitis Media - drug therapy Otitis Media - microbiology Otorhinolaryngology. Stomatology otorrhea Pharmacology. Drug treatments Safety Treatment Outcome tympanostomy tubes Middle ear disease Multicenter study Insertion Otorrhea Fluoroquinolone derivatives Randomization Efficiency Surgery ENT disease Clinical trial Child Quinolone derivatives Human Corticosteroid Grommet Dexamethasone Steroid hormone Acute Antiinflammatory agent Tympanotomy Chemotherapy Otitis media Combined treatment Antibacterial agent Ciprofloxacin Topical administration
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Summary:	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 0.3%/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 corticosteroid 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.
Bibliography:	Supported by a grant from Alcon Research, Ltd., Fort Worth, Texas, U.S.A. istex:9F4485B20A02E508BC3D3EFF5326D6E0A31D8028 ark:/67375/WNG-70HKGN7R-3 ArticleID:LARY5541131211
ISSN:	0023-852X 1531-4995
DOI:	10.1097/00005537-200312000-00011