{
  "abstract": "Objective\n\nAcute 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.Methods\n\nThis 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.Results\n\nCombination 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).Conclusion\n\nAdjunctive 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.Level of evidence\n\n2.",
  "abstract_shown": true,
  "affiliations": [
    "School of Medicine and Medical Sciences Holy Spirit University of Kaslik Jounieh Lebanon.",
    "Saint George Hospital University Medical Center Beirut Lebanon.",
    "Faculty of Medicine Saint George University of Beirut Beirut Lebanon.",
    "Department of Pediatrics American University of Beirut Medical Center Beirut Lebanon.",
    "Department of Otolaryngology American University of Beirut Medical Center Beirut Lebanon."
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 4,
  "authors": [
    {
      "affs": [
        0,
        1,
        2
      ],
      "name": "Elie Ghadban",
      "orcid": "0009-0005-3357-497X"
    },
    {
      "affs": [
        0
      ],
      "name": "Tigresse Boutros"
    },
    {
      "affs": [
        3
      ],
      "name": "Diala Romani"
    },
    {
      "affs": [
        4
      ],
      "name": "Gabriel Dunya"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/cge490edhf4h2.bib",
  "cited_by": 0,
  "doi": "10.1002/lio2.70612",
  "fulltext_url": "https://europepmc.org/articles/PMC13693402",
  "id": "cge490edhf4h2",
  "issns": [
    "2378-8038"
  ],
  "landing_url": "https://europepmc.org/article/MED/42921164",
  "language": "eng",
  "licence": "CC-BY-NC-ND",
  "licence_label": "CC BY-NC-ND",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc-nd/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "openalex",
      "2733|Ear Surgery and Otitis Media"
    ]
  ],
  "openalex": "W7223338637",
  "pdf_url": "https://europepmc.org/articles/PMC13693402?pdf=render",
  "pmcid": "PMC13693402",
  "pmid": "42921164",
  "published": "2026-10-23",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/cge490edhf4h2.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:20:33Z",
      "native_id": "MED:42921164",
      "source": "europepmc",
      "url": "https://europepmc.org/article/MED/42921164"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2733|Ear Surgery and Otitis Media",
      "subfield": "general"
    }
  ],
  "title": "Topical Ciprofloxacin for Non-Perforated Acute Otitis Media: A Randomized Controlled Trial.",
  "title_text": "Topical Ciprofloxacin for Non-Perforated Acute Otitis Media: A Randomized Controlled Trial.",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:20:33Z",
  "url": "https://research.draconitic.com/paper/cge490edhf4h2",
  "venue": "Laryngoscope investigative otolaryngology",
  "versions": []
}