Safety and efficacy of ciprofloxacin in the management of pediatric post-tympanostomy tube otorrhea: a systematic review and meta-analysis.

PURPOSE: This systematic review and meta-analysis aim to evaluate the efficacy and safety of Ciprofloxacin compared to alternative treatments for managing PTTO.

METHODS

A comprehensive search was carried out in PubMed, MEDLINE, Springer, and Embase. Randomized controlled trials and interventional studies were included if they assessed Ciprofloxacin in children (0-18 years) with PTTO following tympanostomy tube insertion. The primary outcomes analyzed were clinical resolution of otorrhea, time to resolution, recurrence rates, and adverse effects. For the meta-analysis, only studies comparing Ciprofloxacin to placebo were included to minimize heterogeneity, and outcomes were analyzed using a random effects model with risk ratios and 95% confidence intervals via RevMan 5.4 software.

RESULTS

Out of 704 identified records, four randomized controlled trials met the inclusion criteria, comprising a total of 1,025 pediatric patients aged 6 months to 14 years. These studies evaluated Ciprofloxacin, either as topical drops or sustained-release intratympanic injections, against a placebo for the prevention or treatment of PTTO. All studies reported that Ciprofloxacin significantly reduced the incidence of otorrhea compared to placebo, with relative risk reductions ranging from approximately 46% to 66%. The pooled meta-analysis of 892 participants demonstrated a statistically significant reduction in otorrhea with Ciprofloxacin treatment (risk ratio 0.53; 95% confidence interval 0.35 to 0.79; p = 0.002), with no observed heterogeneity (I² = 0%).

CONCLUSION

This systematic review and meta-analysis demonstrated that ciprofloxacin, whether administered as topical drops or sustained-release formulations, reduces post-tympanostomy tube otorrhea in children without significant safety concerns.