Objective: To evaluate ciprofloxacin 0.3%/dexamethasone 0.1% (CIPRODEX, Alcon, Ft. Worth, TX) for the prevention of early post-operative otorrhea following TT placement.
Methods: This was a single-center, randomized, evaluator-blinded, parallel-group study. Two hundred children undergoing bilateral TT placement were categorized as having unilateral ("wet/dry"), bilateral ("wet/wet"), or no ("dry/dry") effusion at the time of surgery. All patients received Ciprodex or no treatment for 5 days post-operatively and returned at 2 weeks.
Results: Physician-observed otorrhea was reported in 5 (4.95%) patients receiving Ciprodex and 39 (39.39%) patients receiving no treatment (p<0.0001). Treatment decreased otorrhea in all groups, while the greatest benefit was observed in patients with bilateral effusion (93% reduction). Ciprodex treatment also decreased the rate of clinically diagnosed otitis media (OM) and effusion following TT placement (p< or =0.0006).
Conclusion: Ciprodex reduced early post-operative otorrhea, clinically diagnosed OM and effusion following TT insertion. The greatest reduction in otorrhea was observed in patients with bilateral effusion at the time of surgery.