Abstract
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.
Publication types
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Clinical Trial
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Administration, Topical
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Adolescent
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Anti-Infective Agents / administration & dosage
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Anti-Infective Agents / pharmacology
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Anti-Infective Agents / therapeutic use*
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Anti-Inflammatory Agents / administration & dosage
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Anti-Inflammatory Agents / pharmacology
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Anti-Inflammatory Agents / therapeutic use*
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Cerebrospinal Fluid Otorrhea / complications
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Child
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Ciprofloxacin / administration & dosage
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Ciprofloxacin / pharmacology
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Ciprofloxacin / therapeutic use*
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Dexamethasone / administration & dosage
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Dexamethasone / pharmacology
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Dexamethasone / therapeutic use*
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Drug Administration Schedule
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Drug Therapy, Combination
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Female
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Granulation Tissue / drug effects
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Humans
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Male
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Middle Ear Ventilation / methods*
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Ofloxacin / administration & dosage
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Ofloxacin / pharmacology
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Ofloxacin / therapeutic use*
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Otitis Media with Effusion / complications
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Otitis Media with Effusion / drug therapy*
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Otitis Media with Effusion / surgery*
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Prospective Studies
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Solutions
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Suspensions
Substances
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Anti-Infective Agents
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Anti-Inflammatory Agents
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Solutions
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Suspensions
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Ciprofloxacin
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Dexamethasone
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Ofloxacin