Topical ciprofloxacin/dexamethasone is superior to ciprofloxacin alone in pediatric patients with acute otitis media and otorrhea through tympanostomy tubes.
OBJECTIVE
To determine whether topical administration of a corticosteroid improves resolution of acute tympanostomy tube otorrhea when combined with topical antibiotic drops.


METHODS
Randomized, patient-masked, parallel-group, multicenter trial of topical otic ciprofloxacin/dexamethasone versus topical ciprofloxacin alone in 201 children aged 6 months to 12 years with acute otitis media with tympanostomy tubes (AOMT) of less than or equal to 3 weeks' duration and visible otorrhea.


METHODS
Eligible patients were randomized to receive three drops of either ciprofloxacin 0.3%/dexamethasone 0.1% or ciprofloxacin 0.3% into the affected ear or ears twice daily for 7 days. Clinical signs and symptoms of AOMT were evaluated on days 1 (baseline), 3, 8 (end-of-therapy), and 14 (test-of-cure), and twice-daily assessments of otorrhea were recorded in patient diaries.


RESULTS
The mean time to cessation of otorrhea in the microbiologically culture-positive patient population (n = 167) was significantly shorter with topical ciprofloxacin/dexamethasone than with ciprofloxacin alone (4.22 vs. 5.31 days; P =.004). This resulted in significantly better clinical responses on days 3 and 8 (P <.0001 and P =.0499, respectively). However, there were no significant differences between the two treatment groups in either the clinical response or the microbial eradication rate by day 14.


CONCLUSIONS
Topical otic treatment with ciprofloxacin/dexamethasone is superior to treatment with ciprofloxacin alone and results in a faster clinical resolution in children with AOMT. The contribution of the corticosteroid in achieving a 20% reduction (1.1 day) in time to cessation of otorrhea is clinically meaningful and represents an important advance over single-agent antibiotic therapy.
Roland
Peter S
PS
Department of Otolaryngology, University of Texas Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75390-9035, USA. Peter.Roland@UTSouthwestern.edu
Anon
Jack B
JB
Moe
Richard D
RD
Conroy
Peter J
PJ
Wall
G Michael
GM
Dupre
Sheryl J
SJ
Krueger
Kimberly A
KA
Potts
Susan
S
Hogg
Gail
G
Stroman
David W
DW
D000208:Acute Disease; D000287:Administration, Topical; D002558:Cerebrospinal Fluid Otorrhea / Q000188:drug therapy* / Q000382:microbiology; D002648:Child; D002675:Child, Preschool; D002939:Ciprofloxacin / Q000008:administration & dosage* / Q000009:adverse effects; D003907:Dexamethasone / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008876:Middle Ear Ventilation / Q000009:adverse effects*; D010033:Otitis Media / Q000188:drug therapy* / Q000382:microbiology; D012449:Safety; D016896:Treatment Outcome
D002939:Ciprofloxacin; D003907:Dexamethasone