Rw. Force et al., TOPICAL CIPROFLOXACIN FOR OTORRHEA AFTER TYMPANOSTOMY TUBE PLACEMENT, Archives of otolaryngology, head & neck surgery, 121(8), 1995, pp. 880-884
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.