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Rex W. Force, PharmD; Mary C. Hart, MD; Sally A. Plummer, PhD; Dwight A. Powell, MD; Milap C. Nahata, PharmD

Arch Otolaryngol Head Neck Surg. 1995;121(8):880-884.

Abstract
Objective
To evaluate the efficacy, systemic absorption, and safety of ototopically administered ciprofloxacin in children with otorrhea associated with tympanostomy tube placement.

Design
Nonrandomized, open-label pilot trial with pharmacokinetic determination of the systemic absorption of ototopical ciprofloxacin.

Setting
A pediatric otolaryngology clinic affiliated with Columbus (Ohio) Children's Hospital.

Patients
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 material; failure of previous oral antibiotic therapy; and ability to participate in bone conduction audiometry.

Intervention
Participants received 3 drops (approximately 60 µL) of 0.3% ototopical ciprofloxacin hydrochloride (Ciloxan, Alcon Laboratories Inc, Forth Worth, Tex), three 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 effects. 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 infected 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 effects were noted or reported by the children's parents. One child had abnormal bone conduction audiometry results at baseline. The results of bone conduction audiometry on day 14 were normal in all children. Trough concentrations of ciprofloxacin were determined in eight of 10 children; and peak concentrations were determined in seven of 10 children. Ciprofloxacin was not detected in the plasma of any child.

Conclusion
Topical ciprofloxacin was found to be safe and effective in treating otorrhea in children who did not respond to other treatments.

(Arch Otolaryngol Head Neck Surg. 1995;121:880-884)

Author Affiliations
From the Colleges of Pharmacy (Drs Force and Nahata) and Medicine (Dr Hart), The Ohio State University, the Wexner Institute for Pediatric Research (Drs Force, Powell, and Nahata), and the Department of Speech Pathology and Audiology, Children's Hospital (Dr Plummer), Columbus, Ohio. Dr Force is now with the College of Pharmacy and Department of Family Medicine, Idaho State University, Pocatello.

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