Topical ciprofloxacin/dexamethasone otic suspension is superior to ofloxacin otic solution in the treatment of granulation tissue in children with acute otitis media with otorrhea through tympanostomy tubes.
OBJECTIVE
Comparison of topical ciprofloxacin/dexamethasone otic suspension (CIP/DEX) to ofloxacin otic solution (OFL) for treatment of granulation tissue in children with AOMT.


METHODS
599 children aged >/=6 months to 12 years with AOMT of up to 3 weeks' duration were enrolled. Patients received either CIP/DEX 4 drops twice daily for 7 days or OFL 5 drops twice daily for 10 days. Granulation tissue severity was graded at clinic visits on days 1, 3, 11, and 18.


RESULTS
Granulation tissue was present in 90 of 599 AOMT patients (15.0%) at baseline. CIP/DEX treatment was superior to OFL for reduction of granulation tissue at the day 11 visit (81.3% compared with 56.1%, P = 0.0067) and the day 18 visit (91.7% compared with 73.2%, P = 0.0223). Both topical otic preparations are safe and well tolerated in pediatric patients.


CONCLUSIONS
CIP/DEX was superior to OFL in the treatment of granulation tissue in children with AOMT.
Roland
Peter S
PS
Department of Otolaryngology, University of Texas Southwestern Medical Center, Dallas, TX 75390-9035, USA. Peter.Roland@UTSouthwestern.edu
Dohar
Joseph E
JE
Lanier
Brent J
BJ
Hekkenburg
Robert
R
Lane
Edward M
EM
Conroy
Peter J
PJ
Wall
G Michael
GM
Dupre
Sheryl J
SJ
Potts
Susan L
SL
D000287:Administration, Topical; D000293:Adolescent; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D002558:Cerebrospinal Fluid Otorrhea / Q000150:complications; D002648:Child; D002939:Ciprofloxacin / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D003907:Dexamethasone / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006097:Granulation Tissue / Q000187:drug effects; D006801:Humans; D008297:Male; D008876:Middle Ear Ventilation / Q000379:methods*; D015242:Ofloxacin / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D010034:Otitis Media with Effusion / Q000150:complications / Q000188:drug therapy* / Q000601:surgery*; D011446:Prospective Studies; D012996:Solutions; D013535:Suspensions
D000890:Anti-Infective Agents; D000893:Anti-Inflammatory Agents; D012996:Solutions; D013535:Suspensions; D002939:Ciprofloxacin; D003907:Dexamethasone; D015242:Ofloxacin