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Topical ciprofloxacin for otorrhea after tympanostomy tube placement
R W Force1, M C Hart, S A Plummer
1College of Pharmacy, Ohio State University, Wexner Institute for Pediatric Research, USA.
Insights
Topical ciprofloxacin effectively treated ear infections in children with persistent otorrhea. This study found the antibiotic safe and effective, with no systemic absorption or adverse effects observed in pediatric patients.
Area of Science:
- Pediatric Otolaryngology
- Infectious Diseases
- Pharmacokinetics
Background:
- Otorrhea is a common complication following tympanostomy tube placement in children.
- Persistent otorrhea can lead to treatment challenges and potential hearing impairment.
- Pseudomonas aeruginosa is a frequent causative agent in pediatric otorrhea.
Purpose of the Study:
- To assess the efficacy of topical ciprofloxacin in treating pediatric otorrhea.
- To evaluate the systemic absorption of ototopically administered ciprofloxacin.
- To determine the safety profile of topical ciprofloxacin in children.
Main Methods:
- A nonrandomized, open-label pilot trial was conducted in a pediatric otolaryngology clinic.
- Patients aged 3-8 years with persistent otorrhea and Pseudomonas aeruginosa infection received topical ciprofloxacin for 14 days.
- Pharmacokinetic analysis was performed to measure systemic absorption, alongside audiometry and clinical evaluations for efficacy and safety.
Main Results:
- Topical ciprofloxacin demonstrated high efficacy, with 10 of 11 infected ears showing improvement or cure by day 7, and complete cure by days 14 and 44.
- No systemic absorption of ciprofloxacin was detected in any of the pediatric participants.
- No adverse effects were reported, and bone conduction audiometry results normalized in all children by day 14.
Conclusions:
- Topical ciprofloxacin is a safe and effective treatment for pediatric otorrhea unresponsive to other therapies.
- The drug exhibits minimal to no systemic absorption when administered topically in children.
- This treatment offers a promising alternative for managing challenging cases of otorrhea in pediatric patients.
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 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.
Conclusion:
Topical ciprofloxacin was found to be safe and effective in treating otorrhea in children who did not respond to other treatments.
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