Highlights
In a retrospective cohort of 399 children and adolescents who received postoperative nebulized ciprofloxacin-dexamethasone after airway surgery, no significant adverse events clearly attributable to the drug combination were identified.
The study population was medically complex and predominantly treated for subglottic stenosis, making the absence of observed endocrine, metabolic, and pulmonary toxicity clinically notable.
Most patients received therapy in the inpatient setting for an average of 11.7 days, suggesting this regimen had become routine within the center’s postoperative airway management pathway.
The findings support short-term safety but do not establish efficacy, comparative benefit, or optimal dose and duration; these questions remain appropriate targets for prospective multicenter study.
Background and Clinical Context
Postoperative airway management in children is often a balance between protecting a vulnerable surgical site and avoiding treatment-related toxicity. This is especially true after procedures performed for subglottic stenosis, laryngotracheal reconstruction, supraglottic pathology, or foreign-body-related airway injury. In such settings, clinicians frequently use anti-inflammatory therapies to reduce mucosal edema and antibiotics when concern exists for local bacterial burden, biofilm formation, or postoperative infection risk. However, the evidence base supporting many airway-specific topical or nebulized regimens remains limited.
Nebulized ciprofloxacin-dexamethasone (CPD), using the 0.3%-0.1% otic formulation delivered by nebulization, has emerged in some pediatric airway programs as an off-label postoperative strategy. The rationale is biologically plausible: ciprofloxacin provides broad antimicrobial coverage, while dexamethasone may reduce airway inflammation, granulation tissue, and edema. Yet this approach also raises several safety questions. Corticosteroid exposure in infants and children can theoretically contribute to adrenal suppression, altered glucose homeostasis, impaired healing, and increased infection risk. Aerosolized medications can also provoke bronchial hyperreactivity in susceptible patients. Additionally, the use of an otic formulation by nebulization underscores the importance of careful pharmacovigilance, even when the intended local airway effect is attractive.
Against this background, Landini and colleagues examined the real-world safety profile and use patterns of nebulized CPD after pediatric airway surgery at a tertiary pediatric center. The study is less a test of efficacy than a structured safety signal assessment in a high-risk clinical population.
Study Design and Methods
Design
This was a retrospective chart review conducted at a tertiary pediatric center. The study period spanned 2019 through 2023.
Population
The investigators included pediatric patients who underwent airway surgery and received postoperative nebulized CPD 0.3%-0.1%. Exposure was defined as any postoperative nebulized administration of the combination. A total of 399 patients were identified.
The mean age was 46.2 months, with a range from newborn to 20.7 years. Although the upper age range extended into young adulthood, the cohort reflects a predominantly pediatric airway practice. The case mix was heavily weighted toward subglottic stenosis, which accounted for 92.5% of indications. Other indications included post-laryngotracheal reconstruction care in 5.3%, airway foreign body in 2.0%, and supraglottoplasty in 0.3%.
The population was medically complex. Neurologic conditions were present in 47.6%, cardiac anomalies in 41.6%, and bronchopulmonary dysplasia in 25.1%. These comorbidities matter because they increase baseline vulnerability to respiratory complications, metabolic instability, and prolonged hospitalization, all of which could obscure or amplify drug-related adverse events.
Intervention and Exposure Pattern
Most patients, 93.4%, received nebulized CPD in the inpatient setting. The mean duration of treatment was 11.7 days. The abstract does not report a comparator group, dose frequency, or protocolized variation by surgical procedure, so the study should be interpreted as a single-arm safety experience rather than a comparative effectiveness analysis.
Safety Endpoints
Adverse events were considered potentially CPD-related if they occurred during administration or within 30 days after discontinuation and lacked a better explanation. The safety review focused on endocrine, metabolic, infectious, pulmonary, and inflammatory complications. This framework is clinically sensible for a nebulized antibiotic-steroid combination, particularly in children exposed postoperatively.
Key Findings
Overall Tolerability
The central result is straightforward: among 399 patients exposed to nebulized CPD after airway surgery, the investigators did not identify significant adverse events attributable to the regimen. In a medically complex pediatric cohort, that is a clinically reassuring finding.
Endocrine and Metabolic Safety
No cases of adrenal suppression were identified. No glucose abnormalities were reported. These observations are important because topical and inhaled corticosteroids, while generally safer than systemic corticosteroids, can still produce systemic effects depending on dose, duration, formulation, and mucosal absorption. The absence of recognized adrenal or glycemic toxicity in this cohort suggests that clinically overt systemic dexamethasone effects were not a prominent issue under the center’s typical postoperative use conditions.
At the same time, the result should be interpreted carefully. A retrospective review can only detect what was measured or clinically suspected. If cortisol testing was not routinely performed, subclinical hypothalamic-pituitary-adrenal axis suppression could have gone undetected. Thus, the study is most informative about the absence of apparent clinical toxicity rather than the proven absence of all biologic systemic exposure.
Pulmonary Safety
No bronchial hyperreactivity was identified. This is relevant because nebulized medications may occasionally trigger cough, wheeze, or bronchospasm, especially in children with reactive airway disease or chronic lung disease. Given that 25.1% of the cohort had bronchopulmonary dysplasia, the lack of a detectable pulmonary safety signal is reassuring.
Infectious Complications
One patient developed a suspected airway fungal infection while receiving chemotherapy; however, pathology was negative. This isolated event does not establish a CPD-related infectious complication, and the concurrent chemotherapy introduces a strong alternative explanation for infectious vulnerability. Overall, the study did not identify a convincing signal for infectious harm related to the nebulized antibiotic-steroid combination.
From an antimicrobial stewardship perspective, the study also leaves some unanswered questions. It does not address whether repeated or prolonged use could influence airway microbiology, select for ciprofloxacin resistance, or alter fungal colonization patterns over time. Those questions require prospective surveillance rather than retrospective adverse-event review.
Inflammatory and Endoscopic Findings
Among the 85.7% of patients who underwent postoperative endoscopic evaluation, no significant inflammatory findings were observed. This is a useful descriptive observation, although it should not be overinterpreted as proof of efficacy. Without a control group, it is impossible to know whether the absence of major inflammatory findings reflects the treatment, the surgery itself, natural healing, or broader postoperative care practices. Still, it supports the overall impression that CPD was not associated with visible airway irritation or inflammatory worsening.
Clinical Interpretation
This study addresses a practical question that many pediatric airway surgeons and intensivists face: if nebulized CPD is being used off label after airway surgery, is there evidence of short-term harm? Based on this large single-center experience, the answer appears to be no obvious major harm detected in routine care.
Several aspects strengthen the clinical relevance of the report. First, the cohort is relatively large for pediatric airway surgery research. Second, the patients were medically fragile rather than highly selected, which increases the usefulness of the findings for real-world tertiary care practice. Third, the investigators chose adverse-event categories aligned with the known pharmacology of corticosteroids and inhaled/nebulized therapies.
The findings are especially relevant for postoperative management after treatment of subglottic stenosis, since that diagnosis dominated the cohort. In these children, maintaining airway caliber while minimizing granulation and edema is central to outcome. If nebulized CPD is used in this setting, the current study provides reassurance that major short-term safety problems were not evident during approximately 12 days of average exposure.
Important Limitations
The main limitations arise from study design. Retrospective chart review is vulnerable to incomplete documentation, inconsistent adverse-event ascertainment, and underdetection of subclinical toxicity. There was no untreated or alternative-treatment comparator group, so the study cannot show whether CPD is safer, riskier, or more effective than other postoperative regimens such as inhaled steroids alone, saline, systemic steroids, or no nebulized therapy.
The single-center nature of the study is both a strength and a limitation. It likely reflects a coherent institutional protocol, which improves internal consistency, but it may reduce generalizability to centers with different surgical populations, nebulization techniques, dosing schedules, or postoperative surveillance practices.
The abstract also does not report detailed dosing frequency, particle-delivery method, concurrent steroid exposure, antibiotic exposure, or standardized laboratory monitoring. These factors matter when interpreting safety. For instance, a child receiving systemic corticosteroids in parallel might have masked or confounded dexamethasone-related effects attributable to nebulized CPD alone.
Finally, the study focuses on safety rather than efficacy. It does not answer whether CPD reduces restenosis, granulation tissue, need for repeat intervention, duration of hospitalization, tracheostomy dependence, or other outcomes that would justify routine adoption.
How This Fits With the Broader Evidence Base
There is longstanding interest in topical and inhaled therapies to modulate postoperative airway healing, but the literature remains sparse and heterogeneous. Inhaled corticosteroids have been studied in airway disorders such as subglottic stenosis, croup, and post-extubation edema, yet evidence is often extrapolated across conditions with very different pathobiology. Likewise, ciprofloxacin-dexamethasone is well established in otologic use, but airway nebulization represents a different route, tissue environment, and pharmacokinetic context.
Current pediatric airway practice therefore often relies on local experience, multidisciplinary judgment, and physiologic reasoning rather than high-level comparative evidence. This report contributes meaningful safety data to that gap. What it does not do is settle whether adding ciprofloxacin to dexamethasone is necessary, whether dexamethasone alone would perform similarly, or whether some children derive no measurable benefit from either component.
Guideline-level recommendations specific to nebulized CPD after pediatric airway surgery are not established, and this study does not by itself warrant universal standardization. Rather, it supports the reasonableness of continued cautious use in centers already employing the regimen, ideally alongside prospective outcome tracking.
Implications for Practice and Research
For clinicians, the immediate takeaway is pragmatic. In a large tertiary-care pediatric cohort, nebulized CPD used postoperatively after airway surgery was not associated with a recognizable pattern of serious short-term adverse effects. That is helpful when discussing postoperative management with families and when considering the risk side of the risk-benefit equation.
For researchers, the next steps are clear. Prospective multicenter studies should define dose, frequency, duration, and delivery method; capture systematic endocrine and microbiologic monitoring; and evaluate efficacy endpoints that matter to patients and surgeons. Comparative trials could ask whether CPD outperforms inhaled steroid monotherapy, saline nebulization, or standard care without nebulized therapy. Longer-term follow-up would also help clarify whether repeated exposure influences airway flora, fungal risk, or antimicrobial resistance.
Given the rarity and complexity of many pediatric airway conditions, multicenter collaboration will likely be necessary to obtain sufficiently powered and generalizable data. A standardized core outcome set for pediatric airway surgery trials would further strengthen this field.
Conclusion
Landini and colleagues provide one of the larger real-world safety assessments to date of nebulized ciprofloxacin-dexamethasone after pediatric airway surgery. In 399 patients, most of whom were treated for subglottic stenosis and many of whom had substantial comorbidity, no significant adverse events clearly related to CPD were observed. The study supports short-term tolerability in routine tertiary pediatric airway practice.
At the same time, the evidence remains incomplete. The absence of major observed toxicity does not prove absence of subclinical effects, and the study does not establish efficacy or optimal treatment parameters. For now, nebulized CPD can be viewed as a promising and apparently well-tolerated postoperative adjunct whose role should be refined by prospective, multicenter, outcomes-focused research.
Funding and Trial Registration
Funding information was not provided in the PubMed abstract. A ClinicalTrials.gov registration number was not reported, consistent with the retrospective design.
References
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