title: Topical ciprofloxacin for otorrhea after tympanostomy tube placement.
abstract: OBJECTIVE
  To evaluate the efficacy, systemic absorption, and safety of ototopically administered ciprofloxacin in children with otorrhea associated with tympanostomy tube placement.
  
  
  METHODS
  Nonrandomized, open-label pilot trial with pharmacokinetic determination of the systemic absorption of ototopical ciprofloxacin.
  
  
  METHODS
  A pediatric otolaryngology clinic affiliated with Columbus (Ohio) Children's Hospital.
  
  
  METHODS
  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.
  
  
  METHODS
  Participants received 3 drops (approximately 60 microL) 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.
  
  
  CONCLUSIONS
  Topical ciprofloxacin was found to be safe and effective in treating otorrhea in children who did not respond to other treatments.
authors.affiliation: College of Pharmacy, Ohio State University, Wexner Institute for Pediatric Research, USA.
authors.forename: R W
authors.initials: RW
authors.lastname: Force
authors.forename: M C
authors.initials: MC
authors.lastname: Hart
authors.forename: S A
authors.initials: SA
authors.lastname: Plummer
authors.forename: D A
authors.initials: DA
authors.lastname: Powell
authors.forename: M C
authors.initials: MC
authors.lastname: Nahata
mesh_terms: D000287:Administration, Topical; D001299:Audiometry; D002648:Child; D002675:Child, Preschool; D002908:Chronic Disease; D002939:Ciprofloxacin / Q000008:administration & dosage* / Q000493:pharmacokinetics / Q000627:therapeutic use; D005260:Female; D006309:Hearing; D006801:Humans; D008297:Male; D008876:Middle Ear Ventilation / Q000009:adverse effects*; D010035:Otitis Media, Suppurative / Q000188:drug therapy* / Q000209:etiology*; D010865:Pilot Projects; D016896:Treatment Outcome
chemical_list: D002939:Ciprofloxacin