Assessing National Trends and Perceived Safety of Off‐Label Ciprofloxacin‐Dexamethasone Use by Pediatric Otolaryngologists

Author:

Shah Hemali P.12ORCID,Shah Rema1ORCID,Lockwood Donovan3,Yang Nan4,Rohrbaugh Tagan1ORCID,Rutter Michael J.56,Maurrasse Sarah E.3ORCID

Affiliation:

1. Yale University School of Medicine New Haven Connecticut U.S.A.

2. Department of Otolaryngology‐Head and Neck Surgery Medstar Georgetown University Hospital Washington DC U.S.A.

3. Division of Otolaryngology‐Head and Neck Surgery, Department of Surgery Yale University School of Medicine New Haven Connecticut U.S.A.

4. Yale University School of Public Health New Haven Connecticut U.S.A.

5. Division of Pediatric Otolaryngology‐Head and Neck Surgery Cincinnati Children's Hospital Medical Center Cincinnati Ohio U.S.A.

6. Department of Otolaryngology‐Head and Neck Surgery University of Cincinnati College of Medicine Cincinnati Ohio U.S.A.

Abstract

ObjectivesOff‐label use of Ciprodex® (ciprofloxacin‐dexamethasone: CPD), an antibiotic‐steroid combination solution, in the airway has been reported by pediatric otolaryngologists with anecdotal success. We examined national trends regarding off‐label CPD use including prevalence, common indications, prescriber patterns, adverse events, and accessibility.Methods15‐item cross‐sectional survey was distributed to American Society of Pediatric Otolaryngology members from January–April 2022. Univariate analyses were performed to compare responses for users of off‐label CPD versus non‐users. Ease of access was compared across geographies and practice types using multivariate logistic regressions.ResultsOf the 163 complete responses (26.6% response rate), 156 (95.7%) reported using off‐label CPD. Most common indications for off‐label CPD were tracheal granulation (87.8%, n = 137) and choanal atresia (82.1%, n = 128). Ease of access was significantly increased in the Midwest (OR:18.79, 95%CI:3.63–1.24, p = 0.001) and West (OR:29.92, 95%CI:3.55–682.00, p = 0.006). Ease of access was significantly lower at tertiary referral centers (OR:0.11, 95%CI:0.01–0.64, p = 0.041) and private practices (OR:0.04, 95%CI:0.002–0.33, p = 0.009) compared to academic free‐standing children's hospitals. Two‐thirds of respondents reported feeling “Very Comfortable” with the safety profile of off‐label CPD; 99.4% (n = 156) felt that the benefits outweighed the risks of off‐label use. Seven respondents (4.5%) reported adverse events (e.g., local allergic reaction, cushingoid symptoms) from off‐label use.ConclusionsOur findings (26.6% response rate) suggest that off‐label CPD is commonly used by pediatric otolaryngologists, many of whom reported feeling that the benefits of off‐label CPD outweigh the risks. Our results establish a baseline for future efforts to assess the efficacy and safety of off‐label CPD and to improve its accessibility.Level of EvidenceV Laryngoscope, 2023

Publisher

Wiley

Subject

Otorhinolaryngology

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