TOPICAL CIPROFLOXACIN FOR OTORRHEA AFTER TYMPANOSTOMY TUBE PLACEMENT

Objective: To evaluate the efficacy, systemic absorption, and safety o f ototopically administered ciprofloxacin in children with otorrhea as sociated with tympanostomy tube placement. Design: Nonrandomized, open -label pilot trial with pharmacokinetic determination of the systemic absorption of ototopical ciprofloxacin. Setting: A pediatric otolaryng ology clinic affiliated with Columbus (Ohio) Children's Hospital. Pati ents: Patients aged 3 to 8 years were enrolled if they had persistent otorrhea associated with tympanostomy tube placement. Other inclusion criteria were culture of Pseudomonas aeruginosa from the drainage mate rial; failure of previous oral antibiotic therapy; and ability to part icipate in bone conduction audiometry. Intervention: Participants rece ived 3 drops (approximately 60 mu L) of 0.3% ototopical ciprofloxacin hydrochloride (Ciloxan, Alcon Laboratories Inc, Forth Worth, Tex), thr ee times a day? for 14 days. Bone conduction audiometry was performed at baseline and on day 14. Patients were examined on days 7 and 14 for efficacy of treatment (improvement, cure, failure) and adverse effect s. On day 7, blood samples were drawn just before and 1 hour after the dose was given. Concentrations of ciprofloxacin were measured by high -performance liquid chromatography, with a 5 ng/mL limit of detection. Telephone follow-up was performed on day 44. Parents were asked about adverse effects at days 7, 14, and 44. Results: Mean duration of ear drainage at baseline was 10.7 months (0.75 to 36 months). Ten of 11 in fected ears (nine of 10 patients) were improved or cured at day 7. Ten of 11 ears were completely cured at days 14 and 44. No adverse effect s were noted or reported by the children's parents. One child had abno rmal bone conduction audiometry results at baseline. The results of bo ne conduction audiometry on day 14 were normal in all children. Trough concentrations of ciprofloxacin were determined in eight of 10 childr en; and peak concentrations were determined in seven of 10 children. C iprofloxacin was not detected in the plasma of any child. Conclusion: Topical ciprofloxacin was found to be safe and effective in treating o torrhea in children who did not respond to other treatments.