The use of antibiotic/steroid ear drops to reduce post-operative otorrhoea and blockage of ventilation tubes. A prospective study. Prophylactic ciprofloxacin drops after tympanostomy tube insertion. Clinical efficacy of three common treatments in acute otitis externa in primary care: randomised controlled trial. Preventive therapy for postoperative purulent otorrhea after ventilation tube insertion. A comparison of cortisporin and ciprofloxacin otic drops as prophylaxis against post-tympanostomy otorrhea. Post-tympanostomy otorrhea: a randomized clinical trial of topical prophylaxis. A double-blind randomised placebo-controlled trial of topical intranasal corticosteroids in 4- to 11-year-old children with persistent bilateral otitis media with effusion in primary care. Management for the children with otitis media with effusion in the tertiary hospital. Prevention of early otorrhea in ventilation tubes.
This prospective randomized study investigates whether the use of antibiotic/steroid ear drops (Betnesol-N) is effective in reducing early post-operative otorrhoea and blockage of ventilation tubes (VTs). The study included 162 children who had bilateral VT insertion and used Betnesol-N ear drops in one ear only for three days after surgery, the other ear was left as control. These children were reviewed two weeks later and their ears were examined for VT patency, presence of blood or of mucopus. Statistical analysis of our results showed that the use of Betnesol-N ear drops has significantly reduced the incidence of post-operative otorrhoea within two weeks of VTs insertion (p < 0.01). However, these drops did not have a significant effect on the blockage rates of VTs with dried blood (p > 0.05). To evaluate the effectiveness of prophylactic ciprofloxacin drops in decreasing the incidence of post-tympanostomy otorrhea, and the relation between middle ear content and post-tympanostomy otorrhea.
                One hundred and fifty patients aged 3-14 years underwent tympanostomy and tube insertion at the Prince Rashid Ben Al-Hasan Hospital, Al-Husn, Jordan during the interval between February 2000 to January 2003. The patients were randomized into 3 groups: group 1 (control group) received no antibiotic drops, group 2 received a single dose of ciprofloxacin drops intraoperatively and group 3 received an intraoperative dose followed by 5-day postoperative course.
                Application of topical ciprofloxacin after tympanostomy tube insertion was associated with a significantly lower incidence of early post-tympanostomy otorrhea. The rate of otorrhea for the control group was 16.5% and the treatment groups were (group 1) 8.4%, (group 2) 8.2% and p=0.011. A single dose of antibiotics was effective when patient's middle ears were dry or had serous effusions. For those whose ears had mucoid or purulent content a 5-day course was indicated.
                Topical administration of a single dose of ototopical ciprofloxacin after surgery is an effective treatment for the prevention of early post-tympanostomy otorrhea, and a prolonged course (5 days) may be indicated for those whose ears had purulent or thick mucoid contents, and the content of middle ear are important in predicating postoperative otorrhea. To compare the clinical efficacy of ear drops containing acetic acid, corticosteroid and acetic acid, and steroid and antibiotic in acute otitis externa in primary care.
                Randomised controlled trial.
                79 general practices, Netherlands.
                213 adults with acute otitis externa.
                Primary outcome: duration of symptoms (days) according to patient diaries. Secondary outcome: cure rate according to general practitioner completed questionnaires and recurrence of symptoms between days 21 and 42.
                Symptoms lasted for a median of 8.0 days (95% confidence interval 7.0 to 9.0) in the acetic acid group, 7.0 days (5.8 to 8.3) in the steroid and acetic acid group, and 6.0 days (5.1 to 6.9) in the steroid and antibiotic group. The overall cure rates at seven, 14, and 21 days were 38%, 68%, and 75%, respectively. Compared with the acetic acid group, significantly more patients were cured in the steroid and acetic acid group and steroid and antibiotic group at day 14 (odds ratio 2.4, 1.1 to 5.3, and 3.5, 1.6 to 7.7, respectively) and day 21 (5.3, 2.0 to 13.7, and 3.9, 1.7 to 9.1, respectively). Recurrence of symptoms between days 21 and 42 occurred in 29% (50/172) of patients and was seen significantly less in the steroid and acetic acid group (0.3, 0.1 to 0.7) and steroid and antibiotic group (0.4, 0.2 to 1.0) than in the acetic acid group.
                Ear drops containing corticosteroids are more effective than acetic acid ear drops in the treatment of acute otitis externa in primary care. Steroid and acetic acid or steroid and antibiotic ear drops are equally effective. Treatment modalities which are intraoperative irrigation of the middle ear with isotonic saline, postoperative oral antibiotic treatment, and postoperative topical antibiotic use have been compared with each other and with control group regarding their efficiency in preventing postoperative purulent otorrhea after ventilation tube insertion. Moreover, the costs of the treatment modalities were analyzed.
                Each group consisted of 70 patients, and a total of 280 patients were followed up for purulent otorrhea 2 weeks after the surgery. The study was a single-blind randomized clinical trial.
                Ten (14.28%) patients in the oral antibiotic group, 11 (15.71%) patients in the isotonic saline irrigation group, 6 (8.57%) patients in the topical antibiotic drops group, and 21 (30%) patients in the control group had postoperative purulent otorrhea. Statistical analysis determined a significant difference between each treatment modalities and control group but did not show any significant difference between the treatment groups. When the treatment options were compared according to their cost, however, the cost per successfully treated patient was significantly lower in the saline irrigation group.
                Intraoperative saline irrigation of the middle ear provides an effective, easy, and cheap treatment in preventing postoperative purulent otorrhea. Myringotomy and tube insertion, a common pediatric surgical procedure, is frequently complicated by purulent otorrhea. Many otolaryngologists routinely use topical antibiotics as prophylaxis against post-tympanostomy otorrhea. The aminoglycosides (neomycin sulfate, tobramycin and gentamicin) contained in commonly used topical antibiotics as well as components of the solutions have been shown to be ototoxic in animal studies. Although little reported evidence of ototoxicity in humans exists, sporadic reports of sensorineural hearing loss linked to topical antibiotic use do exist, and the potential for sensorineural hearing loss must be considered. The purpose of this study is to compare the rate of post-tympanostomy otorrhea in a double-blinded randomized trial using either topical Ciprofloxacin, with no reported ototoxicity, or Cortisporin as prophylaxis. One hundred patients (200 ears) between ages 7 months and 11 years with a diagnosis of recurrent otitis media or chronic otitis media undergoing tympanostomy tube insertion were randomized into two equal groups. Three drops of either drop A or B were placed into each ear at the time of tube insertion and then three times daily for 3 days. Patients were examined at 3 weeks and details of otorrhea were obtained. The rate of otorrhea was analyzed using chi-square. The overall rate of otorrhea was 39 ears (19.5%), 17 (17%) ears for the Cortisporin group and 22 (22%) for the Ciprofloxacin group. The difference in rate of otorrhea was not statistically significant (P=0.372, 95% confidence interval equals -6-16%). Our data suggest that topical Cortisporin offers no benefit over Ciprofloxacin for post-operative otorrhea prophylaxis. Therefore we recommend topical quinolone prophylaxis, which should eliminate concerns about ototoxicity, without sacrificing efficacy. Myringotomy with the insertion of tympanostomy tubes has become the most frequently performed otolaryngologic procedure, and otorrhea is the most common post-tympanostomy complication. Many otolaryngologists routinely use prophylactic topical antibiotic solutions when performing tympanostomy tube placement. Relatively little has been written regarding early post-tympanostomy otorrhea and scarcely any examining the efficacy of such prophylaxis. The current study is a randomized clinical trial to critically evaluate the efficacy of prophylactic otic drops after tympanostomy tube placement. The ototoxic potential of these solutions, combined with constant pressures to decrease medication expenses and eliminate unnecessary use of antibiotics, makes determination of the shortest effective course of application paramount. Subjects were randomized at the time of surgery into one of three groups: one group received no prophylaxis, a second group received gentamicin otic drops immediately after tympanostomy tube placement in the operating room only, and the third group received an additional 48 hours of drops (4 drops in each ear, three times a day). All patients were seen within 2 weeks postoperatively. An overall early post-tympanostomy otorrhea incidence of 8.7% is documented with 12%, 8.8%, and 5.6% for each study group, respectively. While these findings may suggest possible efficacy of topical prophylaxis, a statistically significant difference between the treatment groups was not proved (p = 0.62). Further analysis by subdivision of the patients, on the basis of middle ear cavity finding at the time of surgery, reveals a highly significant statistical association of the occurrence of post-tympanostomy otorrhea in ears having mucoid effusions (p less than 0.001) as compared to ears without effusion or with serous effusions.(ABSTRACT TRUNCATED AT 250 WORDS) To determine the clinical effectiveness and cost-effectiveness of topical mometasone in children with bilateral otitis media with effusion (OME).
                A double-blind randomised placebo-controlled trial with an intention to treat analysis; the 10.6% of patients lost to follow-up at 1 month were censored in the analysis.
                76 Medical Research Council General Practice Research Framework practices throughout the UK between 2004 and 2007.
                A sample of 217 children aged 4-11 years was selected from those presenting to their GP with one or more episodes of otitis media or ear-related problems in the previous 12 months whom the research nurse confirmed had bilateral glue ear using microtympanometry (B B or B C2 types using a modified Jerger classification) at randomisation.
                Mometasone 50 micrograms in each nostril or placebo spray once daily for 3 months.
                The primary outcome was the proportions of children cleared of OME assessed by tympanometry at 1 month. Secondary outcomes included clearance at 3 months and 9 months; adverse events; OM8-30 scores (a functional health status responsive disease-specific measure); hearing loss; days with otalgia; cost-effectiveness; and health utilities.
                Of the topical steroid group, 40.6% (39/96) demonstrated tympanometric clearance (C1 or A type) in one or both ears at 1 month, compared with 44.9% (44/98) of the placebo group. The absolute risk reduction at 1 month was -4.3% (95% CI -18.05% to 9.26%); the odds ratio (OR) was 0.84 (95% CI 0.48 to 1.48). Four covariates were pre-specified for inclusion in logistic regression analysis: age as a continuous variable (p = 0.94), season (p = 0.70), atopy (p = 0.61) and clinical severity (p = 0.006). The adjusted OR (AOR) at 1 month for the main outcome was 0.93 (95% CI 0.50 to 1.75). Secondary analysis at 3 months showed 58.1% of the steroid group had resolved and 52.3% of the placebo group, AOR 1.45 (95% CI 0.74 to 2.84). At 9 months 55.6% of the treated group remained clear in at least one ear and 65.3% of the placebo group, AOR 0.82 (95% CI 0.39 to 1.75). Adverse events (although relatively minor) occurred in 7-22% of children and included nasal stinging, epistaxis, dry throat and cough. The OM8-30 scores (p = 0.55) reported hearing difficulty (p = 0.08), and days with otalgia (p = 0.46) were not significantly different between groups at 3 months. The economic evaluation found the active treatment arm to be dominated by placebo, accruing slightly (but not significantly) higher costs and fewer quality-adjusted life-years (QALYs), with a 24.2% probability that topical steroids are a cost-effective use of NHS resources at a ceiling ratio of 20,000 pounds per QALY gained.
                Use of topical intranasal corticosteroids is very unlikely to be a clinically effective treatment for OME (glue ear) in the primary care setting.
                Current Controlled Trials ISRCTN38988331. Recently, new evidence-based recommendations have been introduced for diagnosing and managing otitis media with effusion (OME) in children. However, there are some difficulties to follow the general guidelines in the tertiary hospitals. The purpose is to evaluate the efficiency of antibiotics or antihistamines for treatment of children with OME in the tertiary hospital with a randomized prospective clinical study.
                Eighty-four children with OME who had been diagnosed in the tertiary hospital were randomized to receive 5 different medications for 2 weeks. We prescribed antibiotics (amoxicillin-clavulanate syrup) in Group I (n=16), antibiotics/steroids (prednisolone) in Group II (n=18), antibiotics/antihistamines (ebastine) in Group III (n=15), antibiotics/steroids/antihistamines in Group IV (n=17), and mucolytics (ivy leaf extract) in Group V (n=17) for control. We followed-up children every 2 weeks and evaluated the state of OME at 3 months.
                Thirty six (42.9%) of 84 children were resolved within average 6.9 weeks after the treatments. Thirty-six (42.9%) were treated with ventilation tube insertion and 12 patients (14.3%) were observed. There was no difference in the resolution rates of OME among the five different protocols (P>0.05). There was no difference in the resolution rates among groups who used steroids, antihistamines, steroids and antihistamines, or other medications to manage 42 children with allergies (P>0.05).
                In the tertiary hospital, the cure rate of children with OME was not as high as well-known, and antibiotics or anti-allergic medications were not more effective than control. We may, therefore, need any other guidelines which are different from the previous evidence-based recommendations, including early operation in the tertiary hospitals. The incidence of early postoperative otorrhea after placement of ventilation tubes ranges from 12% to 40%. This prospective randomized study of 430 children, ages 6 months to 15 years, examined the efficacy of sulfacetamide/prednisolone otic drops used for 3 days postoperatively in reducing the incidence of otorrhea at 1 week after the placement of Donaldson tubes. Subjects were randomized into two groups--drops and no drops. Preoperative diagnosis and intraoperative findings were correlated with findings. The incidence of otorrhea among all patients was 11.9%. The use of sulfacetamide/prednisolone drops for 3 days after insertion of ventilation tubes failed to reduce the incidence of otorrhea in the overall study population. The drops did demonstrate a trend toward reducing the incidence of otorrhea in certain subpopulations, including children under 3 years of age, blood at the myringotomy site, and thick middle ear effusions. Subpopulations associated with a higher incidence of otorrhea were also identified.
Our review found that each of the following were effective at reducing the rate of otorrhoea up to two weeks following surgery: (1) multiple saline washouts at surgery, (2) a single application of topical antibiotic/steroid drops at surgery, (3) a prolonged application of topical drops (namely antibiotic ear drops, antibiotic/steroid eardrops or aminoglycoside/steroid ear drops) and (4) a prolonged application of oral antibacterial agents/steroids. However, the rate of otorrhoea between RCTs varied greatly and the higher the rates of otorrhoea within a RCT, the smaller the NNTB for therapy.
We conclude that if a surgeon has a high rate of postoperative otorrhoea in children then either saline irrigation or antibiotic ear drops at the time of surgery would significantly reduce that rate. If topical drops are chosen, it is suggested that to reduce the cost and potential for ototoxic damage this be a single application at the time of surgery and not prolonged thereafter.