Topical Ciprofloxacin for Non-Perforated Acute Otitis Media: A Randomized Controlled Trial

Acute otitis media is a common pediatric infection and a leading cause of oral antibiotic prescriptions. Topical antibiotics are effective in perforated acute otitis media or tympanostomy tube otorrhea but lack evidence in intact tympanic membrane. This study evaluates adjunctive topical ciprofloxacin ear drops use when added to oral antibiotics in non-perforated pediatric otitis media.

This prospective open-labeled randomized controlled trial was conducted between February 2024 and December 2025 at an outpatient pediatric referral clinic. Ninety children (0-15 years) with acute otitis media and intact tympanic membranes were randomized (45 per group). Combined therapy consisted of topical ciprofloxacin ear drops plus oral amoxicillin-clavulanic acid. Primary outcomes included time to complete pain resolution, time to fever resolution, and daily pain trajectory (Faces Pain Scale-Revised). Time-to-event outcomes were analyzed according to the intention-to-treat principle using Kaplan-Meier methods.

Combination therapy accelerated pain and fever resolution. Median time to sustained pain resolution was 3 days with combined therapy versus 5 days with oral therapy alone (RMST₁₀: 3.29 vs. 5.42 days; log-rank p < 0.001). Median time to sustained fever resolution was 4 versus 6 days, respectively (RMST₁₀: 4.76 vs. 5.73 days; log-rank p = 0.033).

Adjunctive topical ciprofloxacin combined with oral antibiotics was associated with faster pain and fever resolution in children with non-perforated acute otitis media, without increasing adverse events, supporting a potential complementary role. These findings are hypothesis-generating and require confirmation in larger populations before informing changes in clinical practice.

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