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Topical ciprofloxacin/dexamethasone is superior to ciprofloxacin alone in pediatric patients with acute otitis media and otorrhea through tympanostomy tubes.
Laryngoscope 2003; 113(12):2116-22L

Abstract

OBJECTIVE

To determine whether topical administration of a corticosteroid improves resolution of acute tympanostomy tube otorrhea when combined with topical antibiotic drops.

STUDY DESIGN

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.

Authors+Show Affiliations

Department of Otolaryngology, University of Texas Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75390-9035, USA. Peter.Roland@UTSouthwestern.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

14660913

Citation

Roland, Peter S., et al. "Topical Ciprofloxacin/dexamethasone Is Superior to Ciprofloxacin Alone in Pediatric Patients With Acute Otitis Media and Otorrhea Through Tympanostomy Tubes." The Laryngoscope, vol. 113, no. 12, 2003, pp. 2116-22.
Roland PS, Anon JB, Moe RD, et al. Topical ciprofloxacin/dexamethasone is superior to ciprofloxacin alone in pediatric patients with acute otitis media and otorrhea through tympanostomy tubes. Laryngoscope. 2003;113(12):2116-22.
Roland, P. S., Anon, J. B., Moe, R. D., Conroy, P. J., Wall, G. M., Dupre, S. J., ... Stroman, D. W. (2003). Topical ciprofloxacin/dexamethasone is superior to ciprofloxacin alone in pediatric patients with acute otitis media and otorrhea through tympanostomy tubes. The Laryngoscope, 113(12), pp. 2116-22.
Roland PS, et al. Topical Ciprofloxacin/dexamethasone Is Superior to Ciprofloxacin Alone in Pediatric Patients With Acute Otitis Media and Otorrhea Through Tympanostomy Tubes. Laryngoscope. 2003;113(12):2116-22. PubMed PMID: 14660913.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Topical ciprofloxacin/dexamethasone is superior to ciprofloxacin alone in pediatric patients with acute otitis media and otorrhea through tympanostomy tubes. AU - Roland,Peter S, AU - Anon,Jack B, AU - Moe,Richard D, AU - Conroy,Peter J, AU - Wall,G Michael, AU - Dupre,Sheryl J, AU - Krueger,Kimberly A, AU - Potts,Susan, AU - Hogg,Gail, AU - Stroman,David W, PY - 2003/12/9/pubmed PY - 2004/1/9/medline PY - 2003/12/9/entrez SP - 2116 EP - 22 JF - The Laryngoscope JO - Laryngoscope VL - 113 IS - 12 N2 - OBJECTIVE: To determine whether topical administration of a corticosteroid improves resolution of acute tympanostomy tube otorrhea when combined with topical antibiotic drops. STUDY DESIGN: 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. SN - 0023-852X UR - https://www.unboundmedicine.com/medline/citation/14660913/Topical_ciprofloxacin/dexamethasone_is_superior_to_ciprofloxacin_alone_in_pediatric_patients_with_acute_otitis_media_and_otorrhea_through_tympanostomy_tubes_ L2 - https://doi.org/10.1097/00005537-200312000-00011 DB - PRIME DP - Unbound Medicine ER -