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Peter S Roland - One of the best experts on this subject based on the ideXlab platform.
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superior semicircular canal dehiscence in patients with spontaneous cerebrospinal fluid Otorrhea
Otolaryngology-Head and Neck Surgery, 2012Co-Authors: Kyle P Allen, Peter S Roland, Carlos L Perez, Brandon Isaacson, Thao Duong, Walter J KutzAbstract:Objective. To determine the prevalence of superior semicir- cular canal dehiscence (SCD) in patients with spontaneous cerebrospinal fluid (CSF) Otorrhea. Study Design. Case series with chart review. Setting. Tertiary care referral center. Subjects and Methods. Patients included have undergone a middle fossa craniotomy for repair of spontaneous CSF Otorrhea between January 2007 and December 2011. The main outcome measure is the presence or absence of SCD observed during spontaneous CSF leak repair. Computed tomography (CT) imaging was also reviewed to determine the diagnostic accuracy of this modality. Results. Thirty-three ears in 31 patients underwent surgical repair for spontaneous CSF Otorrhea via a middle fossa cra- niotomy. The average age at the time of repair was 60.5 years, and 80.6% of patients were female. A dehiscence of the superior canal was observed in 15.2% of ears (16.1% of individuals). No significant difference in age, body mass index, or sex was noted between those patients with or without a superior canal dehiscence. For the diagnosis of SCD, coronal CTwas 100% sensitive and 91.7% specific. The positive predictive value and negative predictive value of CT were 66.7% and 100%, respectively. Conclusion. The prevalence of superior semicircular canal dehiscence in ears with spontaneous Otorrhea is 15.2%. This prevalence is greater than the 0.5% reported in a temporal bone study of ears not selected for CSF Otorrhea.
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management of spontaneous cerebrospinal fluid Otorrhea
Laryngoscope, 2008Co-Authors: Joe Walter Kutz, Brandon Isaacson, Inna Husain, Peter S RolandAbstract:Objectives/Hypothesis: To describe the surgical approaches and materials used to repair spontaneous cerebrospinal fluid (CSF) Otorrhea of temporal bone origin. Study Design: Retrospective case review at a tertiary academic medical center. Methods: All patients presenting with spontaneous CSF Otorrhea or rhinorrhea over a consecutive 8-year period were included. Clinic charts and operative reports were reviewed to obtain the clinical presentation, examination findings, diagnostic test results, intraoperative findings, operative technique, and postoperative follow-up. Surgical approach and materials used for repair were determined by the location of the defect(s) and surgeon preference. Results: Seventeen patients underwent 19 operations for repair of spontaneous CSF Otorrhea or rhinorrhea. The mean age was 61 years and the male to female ratio was 5:12. All female patients had a body mass index (BMI) greater than 30 mg/kg2. The most common presenting symptom was Otorrhea after a myringotomy or placement of a tympanostomy tube. A middle fossa craniotomy was used in 17 approaches. The most common defect sites were located over the tegmen mastoideum and tegmen tympani. Multiple materials were used in most repairs including allogenic bone cement and autologous materials. One patient had persistent Otorrhea after a transmastoid approach and required a middle fossa craniotomy to repair a tegmen mastoideum defect. Conclusions: Spontaneous CSF Otorrhea is uncommon and often not diagnosed until a myringotomy or tympanostomy tube is placed. The middle fossa craniotomy provides the best exposure for defects involving the middle fossa floor. Both alloplastic and autologous materials are highly successful in repairing the defect(s) responsible for CSF Otorrhea. No infections of the alloplastic bone cement occurred in our series.
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topical ciprofloxacin dexamethasone superior to oral amoxicillin clavulanic acid in acute otitis media with Otorrhea through tympanostomy tubes
Pediatrics, 2006Co-Authors: Joseph E Dohar, William Giles, Peter S Roland, Nadim Bikhazi, Sean T Carroll, Roderick Moe, Bradley Reese, Sheryl J Dupre, Michael G Wall, David W StromanAbstract:OBJECTIVE. This study was a comparison of topical ciprofloxacin/dexamethasone otic suspension to oral amoxicillin/clavulanic acid suspension in children with acute otitis media with Otorrhea through tympanostomy tubes. METHODS. This was a randomized, observer-masked, parallel-group, multicenter trial of topical ciprofloxacin/dexamethasone otic suspension versus amoxicillin/clavulanic acid suspension in 80 children aged 6 months to 12 years with acute otitis media with Otorrhea through tympanostomy tubes of ≤3 weeks9 duration and visible Otorrhea. Patients were randomly assigned to receive either 4 drops of topical ciprofloxacin 0.3%/dexamethasone 0.1% (Ciprodex Sterile Otic Suspension) into the affected ear(s) twice daily for 7 days or 600 mg of amoxicillin/42.9 mg of clavulanic acid oral suspension (Augmentin ES-600 Oral Suspension) every 12 hours for 10 days. Clinical signs and symptoms of acute otitis media with Otorrhea through tympanostomy tubes were evaluated on days 1 (baseline), 3, 11 (end-of-therapy), and 18 (test-of-cure), and twice-daily assessments of Otorrhea were recorded in patient diaries. RESULTS. The median time to cessation of Otorrhea was significantly shorter with ciprofloxacin/dexamethasone otic suspension than with amoxicillin/clavulanic acid suspension (4.0 vs 7.0 days; n = 79). This resulted in significantly more clinical cures at the test-of-cure visit (85% vs 59%, respectively). Frequent adverse events (>3%) related to ciprofloxacin/dexamethasone otic suspension included ear pain (5.1%) and related to amoxicillin/clavulanic acid suspension included diarrhea (19.5%), dermatitis (7.3%), and gastroenteritis (4.9%). CONCLUSIONS. Topical otic treatment with ciprofloxacin/dexamethasone otic suspension is superior to treatment with oral amoxicillin/clavulanic acid suspension and results in more clinical cures and earlier cessation of Otorrhea with fewer adverse effects in children with acute otitis media with Otorrhea through tympanostomy tubes.
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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
Pediatrics, 2004Co-Authors: Peter S Roland, Bradley Reese, Sheryl J Dupre, Michael G Wall, Jack B Anon, Peter J Conroy, Susan Potts, Leslie S Kreisler, Brent Lanier, Gail HoggAbstract: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.
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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, 2003Co-Authors: Peter S Roland, Sheryl J Dupre, Michael G Wall, Jack B Anon, Richard D Moe, Peter J Conroy, Kimberly A Krueger, Susan Potts, Gail Hogg, David W StromanAbstract: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.
Joseph E Dohar - One of the best experts on this subject based on the ideXlab platform.
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evidence based telehealth clinical pathway for pediatric tympanostomy tube Otorrhea
International Journal of Pediatric Otorhinolaryngology, 2020Co-Authors: Amber D Shaffer, Joseph E DoharAbstract:Abstract Introduction As healthcare moves away from volume-based to value-based delivery models, evidence based clinical pathways detail essential steps in patient care to reduce the costs and utilization of health care resources. Ideal pathways lead towards standardized, patient-centered care through an algorithm that is evidence-based, interventions with criteria-based progression, and measurable endpoints or quality indicators. Using these standards, a clinical pathway for managing tympanostomy tube Otorrhea beginning with phone triage was developed in accordance with AAO-HNSF Guidelines. Methods A retrospective case series of all consecutive patients calling the otolaryngology nurse's line at a tertiary pediatric hospital 3/2018-11/2018 regarding Otorrhea was performed. Nurses completed a standardized and evidence-based form based on parent responses regarding purulence, tympanostomy tubes/perforation, fever>102°, ear redness, bacterial rhinosinusitis, sore throat, and immunodeficiency, which was sent to the advanced practice providers (APPs) to assess for antibiotic drops. Otorrhea form information and tympanostomy tube history, subsequent phone calls, clinic visits, and antibiotic prescriptions for Otorrhea were extracted. Results Eighty-two patients were included. Median child age at phone call was 2.5 years (range 0.3–20.2 years), and 45.1% were female. All patients had prior tubes and active purulent Otorrhea. No parents reported cellulitis or immunodeficiency. One patient had symptoms of bacterial rhinosinusitis and a sore throat but had already been seen by their primary care provider (PCP) for systemic antibiotics. Antibiotic drops were prescribed by an APP in 96.3% of cases [ofloxacin (n = 57), ciprofloxacin (n = 17), or ciprofloxacin with dexamethasone (n = 5)]. The remaining patients already had drops (2.5%) or were referred to their PCP (1.2%). Twenty (24.4%) received another antibiotic prescription and 17.1% had a subsequent clinic or urgent care visit for Otorrhea. Conclusions This pathway obviated clinic visits in 82.9% of patients with a 75.6% treatment cure.
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novel rat model of tympanostomy tube Otorrhea
International Journal of Pediatric Otorhinolaryngology, 2012Co-Authors: Rodrigo C Silva, Joseph E Dohar, Patricia A HebdaAbstract:Abstract Objective Tympanostomy tube Otorrhea (TTO), caused by the presence of pathogenic bacteria in the middle ear, is the most common complication of TT insertion. No studies have described a reproducible animal model of TTO. We aimed to develop a rat model of TTO which, in turn, could be used to assay the levels of TNF-α and IL-1β through the course of the infection. Methods The left Eustachian tubes of 55 male Sprague-Dawley albino rats were occluded with gutta-percha (ETO = Eustachian Tube Occlusion). Middle ear (ME) effusion was ascertained by weekly otomicroscopy. At 3 weeks tympanostomy tubes were placed bilaterally and the MEs were inoculated bilaterally with Streptococcus pneumoniae through the tubes. The rats were randomly assigned to one of two daily ototopical treatments: ciprofloxacin/dexamethasone (CDX) or placebo. The animals in each of the two treatment groups were further divided to receive 1, 2, 5 or 7 days of treatment. The rats were sacrificed after treatment was finished. The rates of Otorrhea, positive middle ear (ME) cultures, and levels of TNF-α and IL-1β in the ME fluid were measured. Results Left ETO followed by ME inoculation with S. pneumoniae and treatment with placebo resulted in persistent infection (100% culture-positive ME fluid at 10 days) and Otorrhea (85.7%). Persistent infection of the left ear was accompanied by significantly elevated the levels of IL-1β and TNF-α. Ears treated with CDX had lower rates of Otorrhea at all time points and lower levels of IL-1β and TNF-α. Conclusions This study is the first to describe a reproducible animal model of acute TTO. Surgical obstruction of the ET, followed by TT placement and ME inoculation with S. pneumoniae induced persistent Otorrhea and infection. Both IL-1β and TNF-α appear to be potential markers of persistent middle ear infection. This novel model may be used in future studies of the pathogenesis and therapy of TTO.
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ciprofloxacin dexamethasone drops decrease the incidence of physician and patient outcomes of Otorrhea after tube placement
International Journal of Pediatric Otorhinolaryngology, 2007Co-Authors: William Giles, Joseph E Dohar, Kenneth Iverson, Paul Cockrum, Frank Hill, Naomi HillAbstract:Summary Objective To evaluate ciprofloxacin 0.3%/dexamethasone 0.1% (CIPRODEX®, Alcon, Ft. Worth, TX) for the prevention of early post-operative Otorrhea following TT placement. Methods This was a single-center, randomized, evaluator-blinded, parallel-group study. Two hundred children undergoing bilateral TT placement were categorized as having unilateral (“wet/dry”), bilateral (“wet/wet”), or no (“dry/dry”) effusion at the time of surgery. All patients received Ciprodex or no treatment for 5 days post-operatively and returned at 2 weeks. Results Physician-observed Otorrhea was reported in 5 (4.95%) patients receiving Ciprodex and 39 (39.39%) patients receiving no treatment (p Conclusion Ciprodex reduced early post-operative Otorrhea, clinically diagnosed OM and effusion following TT insertion. The greatest reduction in Otorrhea was observed in patients with bilateral effusion at the time of surgery.
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topical ciprofloxacin dexamethasone superior to oral amoxicillin clavulanic acid in acute otitis media with Otorrhea through tympanostomy tubes
Pediatrics, 2006Co-Authors: Joseph E Dohar, William Giles, Peter S Roland, Nadim Bikhazi, Sean T Carroll, Roderick Moe, Bradley Reese, Sheryl J Dupre, Michael G Wall, David W StromanAbstract:OBJECTIVE. This study was a comparison of topical ciprofloxacin/dexamethasone otic suspension to oral amoxicillin/clavulanic acid suspension in children with acute otitis media with Otorrhea through tympanostomy tubes. METHODS. This was a randomized, observer-masked, parallel-group, multicenter trial of topical ciprofloxacin/dexamethasone otic suspension versus amoxicillin/clavulanic acid suspension in 80 children aged 6 months to 12 years with acute otitis media with Otorrhea through tympanostomy tubes of ≤3 weeks9 duration and visible Otorrhea. Patients were randomly assigned to receive either 4 drops of topical ciprofloxacin 0.3%/dexamethasone 0.1% (Ciprodex Sterile Otic Suspension) into the affected ear(s) twice daily for 7 days or 600 mg of amoxicillin/42.9 mg of clavulanic acid oral suspension (Augmentin ES-600 Oral Suspension) every 12 hours for 10 days. Clinical signs and symptoms of acute otitis media with Otorrhea through tympanostomy tubes were evaluated on days 1 (baseline), 3, 11 (end-of-therapy), and 18 (test-of-cure), and twice-daily assessments of Otorrhea were recorded in patient diaries. RESULTS. The median time to cessation of Otorrhea was significantly shorter with ciprofloxacin/dexamethasone otic suspension than with amoxicillin/clavulanic acid suspension (4.0 vs 7.0 days; n = 79). This resulted in significantly more clinical cures at the test-of-cure visit (85% vs 59%, respectively). Frequent adverse events (>3%) related to ciprofloxacin/dexamethasone otic suspension included ear pain (5.1%) and related to amoxicillin/clavulanic acid suspension included diarrhea (19.5%), dermatitis (7.3%), and gastroenteritis (4.9%). CONCLUSIONS. Topical otic treatment with ciprofloxacin/dexamethasone otic suspension is superior to treatment with oral amoxicillin/clavulanic acid suspension and results in more clinical cures and earlier cessation of Otorrhea with fewer adverse effects in children with acute otitis media with Otorrhea through tympanostomy tubes.
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methicillin resistant staphylococcus aureus Otorrhea after tympanostomy tube placement
Archives of Otolaryngology-head & Neck Surgery, 2005Co-Authors: James M Coticchia, Joseph E DoharAbstract:Objective To compare a retrospective cohort of nonhospitalized children with methicillin-resistant Staphylococcus aureus (MRSA) Otorrhea with those with methicillin-sensitive S aureus (MSSA) Otorrhea to determine the risk factors predisposing to MRSA Otorrhea and the treatments used. Design Retrospective case-controlled series. Setting Tertiary pediatric care facility. Patients Seventeen children with MRSA Otorrhea after bilateral myringotomy with tympanostomy tube insertion (BMT in MSSA patients, 54 months. There were 8 boys and 3 girls in the MRSA group and 8 boys and 4 girls in the MSSA group. Interventions Oral, topical, and intravenous antimicrobial agents. Main Outcome Measures Antibiotic exposure and history of otitis media and routine antibiotic administration (topical, oral, or intravenous). Results The following findings were statistically significant ( P ≤ .06, Mann-Whitney test): (1) longer duration of antibiotic treatment after BMT (2) increased number of episodes of acute otitis media before BMT and (3) increased number of courses of antibiotics after BM&T in patients with MRSA vs those with MSSA. Conclusions Methicillin-resistant S aureus Otorrhea is commonly seen as a community-acquired infection in otherwise healthy pediatric outpatients. Risk factors for development of MRSA Otorrhea include the number of episodes of acute otitis media before BM&T and number of treatment courses and duration of antibiotic therapy after BM&T.
Anne G M Schilder - One of the best experts on this subject based on the ideXlab platform.
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Tympanostomy tube Otorrhea in children: prevention and treatment.
Current opinion in otolaryngology & head and neck surgery, 2018Co-Authors: Thijs M. A. Van Dongen, Roger Damoiseaux, Anne G M SchilderAbstract:Purpose of reviewOne in two children treated with tympanostomy tubes, experience episodes of Otorrhea whilst their tubes are in place. In this review, we present the results of the most recent publications on prevention and treatment of tympanostomy tube Otorrhea (TTO).Recent findingsRecent systemat
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cost effectiveness of treatment of acute Otorrhea in children with tympanostomy tubes
Pediatrics, 2015Co-Authors: Thijs M. A. Van Dongen, Anne G M Schilder, Roderick P Venekamp, Ardine G De Wit, Geert J M G Van Der HeijdenAbstract:a,b,f abstract BACKGROUND: Acute Otorrhea is a common problem in children with tympanostomy tubes. We recently demonstrated that treatment with antibiotic-glucocorticoid eardrops is clinically superior to oral antibiotics and initial observation. The aim of this study was to assess the cost-effectiveness of these three common treatment strategies for this condition. METHODS: We performed an open-label pragmatic trial in which 230 children with acute uncomplicated tympanostomy-tube Otorrhea were randomly allocated to receive 1 of 3 treatments: hydrocortisone-bacitracin-colistin eardrops, oral amoxicillin-clavulanate suspension, and initial observation (no assigned medication prescription to fill). Parents kept a daily diary capturing ear-related symptoms, health care resource use, and non-health care costs for 6 months. At 2 weeks and 6 months, the study doctor visited the children at home performing otoscopy. Using a societal perspective, treatment failure (otoscopic presence of Otorrhea at 2 weeks) and number of days with Otorrhea as reported in the daily diary were balanced against the costs. RESULTS:Antibiotic-glucocorticoid eardrops were clinically superior to oral antibiotics and initial observation both at 2 weeks and 6 months. At 2 weeks, mean total cost per patient was US $42.43 for antibiotic-glucocorticoid eardrops, US$70.60 for oral antibiotics, and US$82.03 for initial observation. At 6 months, mean total cost per patient was US$368.20, US$420.73, and US$640.44, respectively. Because of the dominance of eardrops, calculating incremental cost-effectiveness ratios was redundant. CONCLUSIONS: Antibiotic-glucocorticoid eardrops are clinically superior and cost less than oral antibiotics and initial observation in children with tympanostomy tubes who develop Otorrhea.
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acute Otorrhea in children with tympanostomy tubes prevalence of bacteria and viruses in the post pneumococcal conjugate vaccine era
Pediatric Infectious Disease Journal, 2015Co-Authors: Thijs M. A. Van Dongen, Elisabeth A M Sanders, Roderick P Venekamp, Annemarie M J Wensing, Debby Bogaert, Anne G M SchilderAbstract:Background: Acute tympanostomy-tube Otorrhea is a common sequela in children with tympanostomy tubes. Acute tympanostomy-tube Otorrhea is generally a symptom of an acute middle ear infection, whereby middle ear fluid drains through the tube. The widespread use of pneumococcal conjugate vaccination (PCV) has changed the bacterial prevalence in the upper respiratory tract of children, but its impact on bacterial and viral pathogens causing acute tympanostomy-tube Otorrhea is yet unknown. Methods: This study was performed in the post-PCV7 era parallel to a randomized clinical trial of the clinical and cost–effectiveness of ototopical and systemic antibiotics and initial observation in 230 children aged 1 to 10 years with untreated, uncomplicated acute tympanostomy-tube Otorrhea. Otorrhea and nasopharyngeal samples were collected at baseline (before treatment) and at 2 weeks (after treatment). Conventional bacterial culture was performed followed by antimicrobial-resistance assessment. Viruses were identified by polymerase chain reaction. Results: At baseline, Haemophilus influenzae (41%), Staphylococcus aureus (40%) and Pseudomonas aeruginosa (18%) were the most prevalent bacteria in Otorrhea, followed by Streptococcus pneumoniae (7%) and Moraxella catarrhalis (4%). Most pneumococci were non-PCV7 serotypes. Viruses were detected in 45 Otorrhea samples at baseline (21%). Most infections were polymicrobial and overall antimicrobial resistance was low. Conclusions: H. influenzae, S. aureus and P. aeruginosa are the most common microorganisms in children with untreated uncomplicated acute
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a trial of treatment for acute Otorrhea in children with tympanostomy tubes
The New England Journal of Medicine, 2014Co-Authors: Thijs M. A. Van Dongen, Maroeska M Rovers, Roderick P Venekamp, Geert J M G Van Der Heijden, Anne G M SchilderAbstract:Background Recent guidance for the management of acute Otorrhea in children with tympanostomy tubes is based on limited evidence from trials comparing oral antibiotic agents with topical antibiotics. Methods In this open-label, pragmatic trial, we randomly assigned 230 children, 1 to 10 years of age, who had acute tympanostomy-tube Otorrhea to receive hydrocortisone–bacitracin–colistin eardrops (76 children) or oral amoxicillin–clavulanate suspension (77) or to undergo initial observation (77). The primary outcome was the presence of Otorrhea, as assessed otoscopically, 2 weeks after study-group assignment. Secondary outcomes were the duration of the initial Otorrhea episode, the total number of days of Otorrhea and the number of Otorrhea recurrences during 6 months of follow-up, quality of life, complications, and treatment-related adverse events. Results Antibiotic–glucocorticoid eardrops were superior to oral antibiotics and initial observation for all outcomes. At 2 weeks, 5% of children treated with ...
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effectiveness of trimethoprim sulfamethoxazole for children with chronic active otitis media a randomized placebo controlled trial
Pediatrics, 2007Co-Authors: Erwin L Van Der Veen, Maroeska M Rovers, Frans W J Albers, Elisabeth A M Sanders, Anne G M SchilderAbstract:OBJECTIVE: The goal was to determine the clinical effectiveness of prolonged outpatient treatment with trimethoprim/sulfamethoxazole for children with chronic active otitis media. METHODS: We performed a randomized, placebo-controlled trial with 101 children (1-12 years of age) with chronic active otitis media (defined as Otorrhea for > or =12 weeks). In addition to a short course of steroid and antibiotic eardrops, children were assigned randomly to receive 6 to 12 weeks of orally administered trimethoprim/sulfamethoxazole (18 mg/kg, 2 times per day) or placebo and were monitored for 1 year. RESULTS: At 6 weeks, 28% of children in the trimethoprim/sulfamethoxazole group and 53% of children in the placebo group had otomicroscopic signs of Otorrhea. At 12 weeks, these values were 32% and 47%, respectively. At 1 year, the numbers of children with Otorrhea were similar in the 2 groups (25% and 20%, respectively). One child in the trimethoprim/sulfamethoxazole group developed a skin rash. Vomiting or diarrhea was reported for 9% of the trimethoprim/sulfamethoxazole group and 2% of the placebo group. Pure-tone hearing levels and health-related quality of life improved during the study but did not differ between the trimethoprim/sulfamethoxazole group and the placebo group. Pseudomonas aeruginosa was the most frequently isolated bacteria in the Otorrhea samples from both groups. CONCLUSIONS: A 6- to 12-week course of high-dose, orally administered trimethoprim/sulfamethoxazole therapy is beneficial for children with chronic active otitis media. The treatment effect is most pronounced with the shorter course and disappears if administration of the medication is discontinued.
David W Stroman - One of the best experts on this subject based on the ideXlab platform.
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topical ciprofloxacin dexamethasone superior to oral amoxicillin clavulanic acid in acute otitis media with Otorrhea through tympanostomy tubes
Pediatrics, 2006Co-Authors: Joseph E Dohar, William Giles, Peter S Roland, Nadim Bikhazi, Sean T Carroll, Roderick Moe, Bradley Reese, Sheryl J Dupre, Michael G Wall, David W StromanAbstract:OBJECTIVE. This study was a comparison of topical ciprofloxacin/dexamethasone otic suspension to oral amoxicillin/clavulanic acid suspension in children with acute otitis media with Otorrhea through tympanostomy tubes. METHODS. This was a randomized, observer-masked, parallel-group, multicenter trial of topical ciprofloxacin/dexamethasone otic suspension versus amoxicillin/clavulanic acid suspension in 80 children aged 6 months to 12 years with acute otitis media with Otorrhea through tympanostomy tubes of ≤3 weeks9 duration and visible Otorrhea. Patients were randomly assigned to receive either 4 drops of topical ciprofloxacin 0.3%/dexamethasone 0.1% (Ciprodex Sterile Otic Suspension) into the affected ear(s) twice daily for 7 days or 600 mg of amoxicillin/42.9 mg of clavulanic acid oral suspension (Augmentin ES-600 Oral Suspension) every 12 hours for 10 days. Clinical signs and symptoms of acute otitis media with Otorrhea through tympanostomy tubes were evaluated on days 1 (baseline), 3, 11 (end-of-therapy), and 18 (test-of-cure), and twice-daily assessments of Otorrhea were recorded in patient diaries. RESULTS. The median time to cessation of Otorrhea was significantly shorter with ciprofloxacin/dexamethasone otic suspension than with amoxicillin/clavulanic acid suspension (4.0 vs 7.0 days; n = 79). This resulted in significantly more clinical cures at the test-of-cure visit (85% vs 59%, respectively). Frequent adverse events (>3%) related to ciprofloxacin/dexamethasone otic suspension included ear pain (5.1%) and related to amoxicillin/clavulanic acid suspension included diarrhea (19.5%), dermatitis (7.3%), and gastroenteritis (4.9%). CONCLUSIONS. Topical otic treatment with ciprofloxacin/dexamethasone otic suspension is superior to treatment with oral amoxicillin/clavulanic acid suspension and results in more clinical cures and earlier cessation of Otorrhea with fewer adverse effects in children with acute otitis media with Otorrhea through tympanostomy tubes.
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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, 2003Co-Authors: Peter S Roland, Sheryl J Dupre, Michael G Wall, Jack B Anon, Richard D Moe, Peter J Conroy, Kimberly A Krueger, Susan Potts, Gail Hogg, David W StromanAbstract: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.
Olli Ruuskanen - One of the best experts on this subject based on the ideXlab platform.
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the dynamics of bacteria in the middle ear during the course of acute otitis media with tympanostomy tube Otorrhea
Pediatric Infectious Disease Journal, 2007Co-Authors: Aino Ruohola, Terho Heikkinen, Olli Meurman, Simo Nikkari, Tuukka Skottman, Olli RuuskanenAbstract:Background: Dynamics of bacteria during acute otitis media (AOM) has not been thoroughly studied because it requires repeated tympanocentesis. AOM with tympanostomy tube Otorrhea provides a unique opportunity to study the appearance and disappearance of pathogens during the course of the disease without stressing the child. Methods: Middle ear fluid (MEF) samples were taken before treatment (amoxicillin clavulanate or placebo) and then daily during follow-up from 75 children having AOM with Otorrhea through a tympanostomy tube. Bacteria were identified by culture, and typical AOM pathogens also by polymerase chain reaction. Results: Bacteria were initially shown in 67 (89%) children. New bacteria appeared in MEF more often in placebo than in amoxicillin clavulanate recipients [9 of 38 (24%) versus 2 of 37 (5%); P = 0.032]. During the follow-up, new occurrences of Moraxella catarrhalis were detected in MEF more frequently than those of Streptococcus pneumoniae or Haemophilus influenzae. Of the 28 patients with bilateral Otorrhea, 11 (39%) had disparate bacteria at study entry and/or during the follow-up. Conclusions: Changes in bacterial findings during the course of AOM are common in patients not receiving treatment, and even possible despite adequate treatment. In bilateral Otorrhea, disparate bacterial findings are common.
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antibiotic treatment of acute Otorrhea through tympanostomy tube randomized double blind placebo controlled study with daily follow up
Pediatrics, 2003Co-Authors: Aino Ruohola, Terho Heikkinen, Olli Meurman, Tuomo Puhakka, Niklas Lindblad, Olli RuuskanenAbstract:Objective.The role of routine antimicrobial treatment of acute middle-ear infections is under debate, because the efficacy of antimicrobials in the resolution of middle-ear fluid has not been unambiguously proven. Acute tube Otorrhea is regarded as evidence of acute otitis media, and for methodologic reasons it was chosen to provide objectivity for diagnostics and outcome assessment. The objective of this study was to assess whether amoxicillin-clavulanate accelerates the resolution of acute tube Otorrhea. Design and setting.Randomized, double-blind, placebo-controlled study in outpatient setting. Patients.Volunteer sample of basically healthy 6- to 72-month-old children with a tympanostomy tube. Eligibility required having acute tube Otorrhea of Interventions.Amoxicillin-clavulanate (N = 34; 45 mg/kg/d) or matching placebo (N = 32) for 7 days and daily suction of middle-ear fluid through tympanostomy tube. Main outcome measures.Duration of acute tube Otorrhea and duration of bacterial growth in middle-ear fluid. Results.The median duration of tube Otorrhea was significantly shorter in amoxicillin-clavulanate than in the placebo group (3 vs 8 days). At the end of the 7-day medication period, tube Otorrhea was resolved in 28 of 34 children receiving amoxicillin-clavulanate compared with 13 of 32 children on placebo (treatment-control difference 41%; 95% confidence interval, 20%–63%; number needed to treat, 2.4). The median duration of bacterial growth in middle-ear fluid was shorter in amoxicillin-clavulanate than in the placebo group (1 vs 8 days). Conclusions.Oral antibiotic treatment significantly accelerates the resolution of acute tube Otorrhea by reducing bacterial growth in middle-ear fluid.
