Topical Ciprofloxacin/Dexamethasone is Superior to Ciprofloxacin Alone in Pediatric Patients with Acute Otitis Media and Otorrhea through Tympanostomy Tubes

Roland, Peter S.; Anon, Jack B.; Moe, Richard D.; Conroy, Peter J.; Wall, G. Michael; Dupre, Sheryl J.; Krueger, Kimberly A.; Potts, Susan L.; Hogg, Gail; Stroman, David W.

doi:10.1097/00005537-200312000-00011

Cited by 67 publications

(60 citation statements)

References 21 publications

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“…4,5,16,17 The present study shows that the addition of the corticosteroid dexamethasone to the fluoroquinolone ciprofloxacin achieves superior rates of clinical cure and microbiologic success, results in fewer treatment failures, and provides earlier resolution of AOMT compared with treatment with the single-agent fluoroquinolone ofloxacin. In this regard, the findings confirm our earlier clinical report of ciprofloxacin/dexamethasone versus ciprofloxacin 15 and in experimental animal studies showing that antibiotic/dexamethasone combinations are more effective than antibiotic therapy alone in resolving otorrhea in a primate model of CSOM 14 and in reducing and preventing persistent middle ear mucosal changes in rats with experimental AOM. 20 In the current AOMT study in children aged Ն6 months to 12 years, we show that a 7-day course of ciprofloxacin/dexamethasone (4 drops twice daily, 56 total drops) with less total drug administered is superior to a 10-day course of ofloxacin (5 drops twice daily, 100 total drops) for clinical cure, microbial eradication, and treatment failures.…”

Section: Discussionsupporting

confidence: 88%

“…15 Otorrhea resolved more rapidly with the combination preparation than with ciprofloxacin alone and produced significantly greater clinical responses early after completion of a 7-day course of treatment. 15 The present study was designed to evaluate further the efficacy and the safety of the topical ciprofloxacin/ dexamethasone combination by comparing it with the related fluoroquinolone ofloxacin administered alone in children with AOMT. Topical ofloxacin was chosen as the comparator for this study because of its reported efficacy and safety in ear infections, including AOMT, 16,17 CSOM, 18 and acute otitis externa.…”

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confidence: 95%

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Topical Ciprofloxacin/Dexamethasone Otic Suspension Is Superior to Ofloxacin Otic Solution in the Treatment of Children With Acute Otitis Media With Otorrhea Through Tympanostomy Tubes

Roland

Kreisler²,

Reese³

et al. 2004

Pediatrics

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ABSTRACT. Objective. To determine the efficacy and safety of topical ciprofloxacin/dexamethasone otic suspension compared with ofloxacin otic solution in the treatment of acute otitis media with otorrhea through tympanostomy tubes (AOMT) in pediatric patients.Methods. This multicenter, prospective, randomized, observer-masked, parallel-group study was conducted at 39 sites in 599 children aged >6 months to 12 years with an AOMT episode of <3 weeks' duration. The mean age of patients was 2.5 years (standard deviation: 2.37 years). Patients received either ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension 4 drops twice daily for 7 days or ofloxacin 0.3% otic solution 5 drops twice daily for 10 days. Clinical signs and symptoms of AOMT were evaluated at clinic visits on days 1 (baseline), 3 (on therapy), 11 (end of therapy), and 18 (test of cure). A patient diary was used to measure time to cessation of otorrhea. Principal pretherapy pathogens included Streptococcus pneumoniae (16.8%), Staphylococcus aureus (13.0%), Pseudomonas aeruginosa (12.7%), Haemophilus influenzae (12.4%), S epidermidis (10.2%), and Moraxella catarrhalis (4.1%).Results. Ciprofloxacin/dexamethasone is superior to ofloxacin for clinical cure (90% vs 78%) and microbiologic success (92% vs 81.8%) at the test-of-cure visit, produces fewer treatment failures (4.4% vs 14.1%), and results in a shorter median time to cessation of otorrhea (4 days vs 6 days). Ciprofloxacin/dexamethasone treatment is also superior to improvement in clinical response by visit, absence of otorrhea by visit, and reduction of otorrhea volume by visit. Both topical otic preparations are safe and well tolerated in pediatric patients. No change in speech recognition threshold or decrease in hearing from baseline, based on audiometric testing, was noted with either regimen.Conclusion. Topical ciprofloxacin/dexamethasone treatment is superior to topical ofloxacin in the treatment of AOMT. Pediatrics 2004;113:e40 -e46. URL: http://www. pediatrics.org/cgi/content/full/113/1/e40; ciprofloxacin, dexamethasone, ofloxacin, otorrhea, AOM, tympanostomy tubes.ABBREVIATIONS. AOMT, acute otitis media with otorrhea through tympanostomy tubes; CSOM, chronic suppurative otitis media; TOC, test of cure; ITT, intention-to-treat.T he most common surgery performed in children for treatment of recurrent otitis media with effusion is the insertion of a tympanostomy tube into the eardrum. 1 However, otorrhea is a common complication after their insertion. The vast majority (90%-95%) of cases of acute otitis media with otorrhea through tympanostomy tubes (AOMT) occur in children aged 1 to 12 years, and typically 2 to 6 episodes of AOMT are experienced. 2,3 Topical ciprofloxacin is an effective and safe therapy for AOMT 4,5 and chronic suppurative otitis media (CSOM). 6 -8 Bacteria commonly isolated from patients with AOMT include Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, and Pseudomonas aeruginosa. 3 Because of the inflammatory response indu...

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Section: Discussionsupporting

confidence: 88%

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confidence: 95%

Topical Ciprofloxacin/Dexamethasone Otic Suspension Is Superior to Ofloxacin Otic Solution in the Treatment of Children With Acute Otitis Media With Otorrhea Through Tympanostomy Tubes

Roland

Kreisler²,

Reese³

et al. 2004

Pediatrics

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“…It has also shown that combination therapy including dexamethasone has been to be more effective than antibiotic alone in the treatment of acute otitis media and otorrhea through a patent tympanostomy tube. The addition of dexamethasone is also more effective in the reduction of granulation tissue than antibiotic therapy alone [12,15,21]. In this study, we have found that ITD is also more effective than conventional therapy in the reduction of hearing loses and middle ear pressure in this study.…”

Section: Discussionsupporting

confidence: 54%

Effectiveness of Intratympanic Dexamethasone in Otitis Media with Effusion Resistant to Conventional Therapy

Paksoy¹,

Altın²,

Eken³

et al. 2011

Indian J Otolaryngol Head Neck Surg

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The aim of this study was to determine the efficiency of intratympanic dexamethasone (ITD) injections as a new treatment modality in otitis media with effusion resistant to conventional therapy. We planned a nonrandomized prospective study to determine the safety and effectiveness of the direct administration of dexamethasone into middle ear cavity with chronic eustachian tube dysfunction. This study was applied on 75 ears of 64 patients aged from 12 to 60 years. ITD received 47 ears of 41 patients who had previously been treated by medical or surgical therapy middle ear effusion without resolution classified as study group. They were taken conventional medical therapy again 28 ears of 23 patients classified as a control group. ITDs were administered 0.5 ml/4 mg per mm directly in antero-superior quadrant of tympanic membrane. These injections were repeated once a week for 4 weeks. Results were evaluated by using audiometric and tympanometric measurements 1 and 3 months after the treatments. Audiometric measurement shows that 9.91 dB improvement in the mean air-bone gap 15.17 dB in air conduction (AC) pure-tone averages (PTA) and 5.25 dB bone conduction (BC) PTA. But the control group data showed only 2 dB improvement in the mean air-bone gap, 3 dB AC-PTA and 1.36 dB BC-PTA. Tympanometric improvement was found. In 28 ears of patients (59.6%) like type B or C converted to type A in study group without complication but only in three ears (10.7%) of control group. ITD administration to the middle ear is safe and effective for the treatment of otitis media with effusion or chronic eustachian tube dysfunction. No complications like tympanic membrane perforation and/or sensorineural hearing loss have occurred.

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“…Ciprodex demonstrates no ototoxicity in animal studies [15] and in clinical trials with patients with TTs, ciprofloxacin demonstrates a favorable safety profile with no detrimental effects on hearing [16][17][18]. One clinical question is whether the steroid component will slow healing of the tympanic membrane, resulting in an increase number of tympanic membrane perforations.…”

Section: Discussionmentioning

confidence: 99%

Ciprofloxacin/dexamethasone drops decrease the incidence of physician and patient outcomes of otorrhea after tube placement

Giles¹,

Dohar

Iverson

et al. 2007

International Journal of Pediatric Otorhinolaryngology

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Topical Ciprofloxacin/Dexamethasone is Superior to Ciprofloxacin Alone in Pediatric Patients with Acute Otitis Media and Otorrhea through Tympanostomy Tubes

Cited by 67 publications

References 21 publications

Topical Ciprofloxacin/Dexamethasone Otic Suspension Is Superior to Ofloxacin Otic Solution in the Treatment of Children With Acute Otitis Media With Otorrhea Through Tympanostomy Tubes

Topical Ciprofloxacin/Dexamethasone Otic Suspension Is Superior to Ofloxacin Otic Solution in the Treatment of Children With Acute Otitis Media With Otorrhea Through Tympanostomy Tubes

Effectiveness of Intratympanic Dexamethasone in Otitis Media with Effusion Resistant to Conventional Therapy

Ciprofloxacin/dexamethasone drops decrease the incidence of physician and patient outcomes of otorrhea after tube placement

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