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Safety and Efficacy of a topical combination of Neomycin, Clotrimazole, Beclomethasone and Lignocaine for management of Ear Infections: Phase IV Study
Abstract
Introduction: Otitis or ear infection is very common in developing countries like India and is often due mixed pathogens. Multi-drug therapy is often used in the treatment of Otitis. We studied the safety and efficacy of one such combination of anti-bacterial (Neomycin), anti-fungal (Clotrimaole), steroid (Beclomethasone) and local anaesthetic (Lignocaine) in the treatment of middle and external ear infections.
Methodology: Total 196 patients were enrolled out of which 160 patients completed the study. Efficacy assessment was made by reduction in Total Symptom Score (TSS) of ear pain, ear discharge and ear itching related to Otitis media with perforation and Otitis Externa. Safety assessment was made by analysing the adverse events through the study.
Results: Reduction in mean TSS score was done from 5.73(baseline) to 2.19(day 3) to 0.21(day 5) of ear pain, from 5.63 (baseline) to 1.73 (day 3) to 0.15(day 5) of ear discharge and from 4.84 (baseline) to 1.48(day 3) to 0.13(day 5) of ear itching. Nearly all the patients had >50% reduction in their TSS at all visits in all the parameters. 21 episodes of adverse events occurred and all of them were of mild intensity.
Conclusion: A combination of Neomycin, Clotrimazole, Beclomethasone Dipropionate and Lignocaine is safe and effective in the treatment of mixed infection of the external and middle ear (with perforation).
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Ear infection is a common problem for both children and adults especially in developing countries. However in Ethiopia particularly in the study area, there is no recent data that shows the magnitude of the problem. The aim of this study was to determine the bacterial isolates and their drug susceptibility patterns from patients who had ear infection.
A retrospective study was conducted from September, 2009 to August, 2012 at Gondar University Hospital, Northwest Ethiopia. Ear discharge samples were cultured on MacConkey agar, blood agar and chocolate agar plates. A standard biochemical procedure was used for full identification of bacterial isolates. Antimicrobial susceptibility tests were done on Mueller-Hinton agar by using disk diffusion method. Data were entered and analyzed by using SPSS version 20 software and P-value of < 0.05 was considered statistically significant.Result: A total of 228 ear discharge samples were tested for bacterial isolation and 204 (89.5%) cases were found to have bacterial isolates. From the total bacterial isolates, 115 (56.4%) were gram negative bacteria and the predominant isolate was proteus species (27.5%). Of individuals who had ear infection, 185 (90.7%) had single bacterial infection while 19 (9.3%) had mixed infections. Under five children were more affected by ear infection. The prevalence of ear infection was significantly high in males (63.7 vs 36.3%) (P = 0.017). Of all bacterial isolates, 192 (94.1%) had multiple antibiotic resistant pattern. Non Lactose Fermenter Gram Negative Rods (46.0%), Klebsella species (47.7%) and Pseudomonas species (48.5%) were resistant against the commonly used antibiotics.
The prevalence of ear infection was very high in the study area. Majority of the bacterial isolates were resistant to multiple antibiotics. Hence antibiotics susceptibility test is mandatory before prescribing any antibiotics.
Otitis media (OM) is a leading cause of health care visits and drugs prescription. Its complications and sequelae are important causes of preventable hearing loss, particularly in developing countries. Within the Global Burden of Diseases, Injuries, and Risk Factors Study, for the year 2005 we estimated the incidence of acute OM, chronic suppurative OM, and related hearing loss and mortality for all ages and the 21 WHO regional areas.
We identified risk factors, complications and sequelae of OM. We carried out an extensive literature review (Medline, Embase, Lilacs and Wholis) which lead to the selection of 114 papers comprising relevant data. Data were available from 15 of the 21 WHO regions. To estimate incidence and prevalence for all countries we adopted a two stage approach based on risk factors formulas and regression modelling.
Acute OM incidence rate is 10.85% i.e. 709 million cases each year with 51% of these occurring in under-fives. Chronic suppurative OM incidence rate is 4.76 ‰ i.e. 31 million cases, with 22.6% of cases occurring annually in under-fives. OM-related hearing impairment has a prevalence of 30.82 per ten-thousand. Each year 21 thousand people die due to complications of OM.
Our study is the first attempt to systematically review the available information and provide global estimates for OM and related conditions. The overall burden deriving from AOM, CSOM and their sequelae is considerable, particularly in the first five years of life and in the poorest countries. The findings call for incorporating OM-focused action within preventive and case management strategies, with emphasis on the more affected.
To compare the efficacy of treatment between steroid-antibiotic and 10% Ichthammol glycerine packs (IG packs) in acute otitis externa. A prospective, randomized clinical trial between steroid-antibiotic and 10% IG pack which was performed in department of ENT-HNS, Kathmandu University Hospital, Dhulikhel from July 2009 to December 2009 on 82 patients. Pain was assessed by Numerical Rating Scale (NRS) and edema was assessed by dividing the external auditory canal in four quadrant giving score of 25% for each on the day of presentation and subsequent visits till tragal tenderness and edema subsided. Age group among studied patients ranged from 10 to 60 years, with mean of 23.5 years. Out of which 42 (51.2%) were females and 40 (48.8%) were males. Average number of visits in 10% IG pack group (n = 41) was 5.4 days (2-5 visits) while in steroid-antibiotic group (n = 41) it was 3.5 days (2-5 visits). There was statistically significant decrease in the number of visits in steroid group (P < 0.05). Similarly, decrease in pain score in second visit was statistically significant (P = 0.02) in steroid-antibiotic group as compared to 10% IG pack, while the edema score in second visit while comparing steroid-antibiotic group with 10% IG pack was statistically not significant (P = 0.07), whereas it was statistically highly significant on fourth visit (P = 0.001). Since the control of pain and edema is more and hence the number of visits is significantly less in steroid-antibiotic packing group, so it is worthwhile to use steroid-antibiotic pack for effective treatment of acute otitis externa.
Otomycosis is a fungal infection of the external ear; middle ear and open mastoid cavity.1 Meyer first described the fungal infection of the external ear canal in 1884. External ear canal has an ideal warm humid environment for the proliferation of fungus.2 Although this disease is rarely life threatening, it can presents a challenging and frustrating situation for the otologist and patients due to long term treatment and high rate of recurrence.3 Otomycosis is seen more frequently in immunocompromised patients as compared to immunocompetent persons. Recurrence rate is high in immunocompromised patients and they need longer duration treatment and complications are more frequent in immunocompromised patients.
In the recent years; opportunistic fungal infections are gaining greater importance in human medicine as a result of possibly huge number of immunocompromised patients.4 In immunocompromised patients, it is important that the treatment of otomycosis be vigorous, to minimize complications such as hearing loss, tympanic membrane perforations and invasive temporal bone infection.5 Fungal cultures are essential to confirm the diagnosis.
Hematological investigations play a very important role in confirming the diagnosis and immunity status of the patients. In diabetic patients with otomycosis, along with antifungal therapy, blood sugar levels should be controlled with medical therapy to prevent complications.
Postherpetic neuralgia (PHN) following herpes zoster is a common and disabling neuropathic pain syndrome. In a double-blind, three-session study, 5% lidocaine gel or vehicle was applied simultaneously to both the area of pain and to the contralateral mirror-image unaffected skin. In the local session, lidocaine gel was applied to the painful skin area. In the remote session, lidocaine gel was applied to mirror-image skin. In the placebo session, vehicle was applied bilaterally. For cranial PHN, gel was applied without occlusion for 8 hours. For limb or torso PHN, gel was applied under occlusion for 24 hours. The 16 subjects with cranial PHN reported pain relief significantly favoring local drug application at 30 minutes, 2, 4, and 8 hours. The 23 subjects with torso or limb PHN reported significantly lower pain intensity with local drug application at 8 hours and both pain relief and reduced pain intensity at 24 hours. Remote lidocaine application to mirror-image skin was no different from placebo. No systemic adverse effects were reported and blood levels did not exceed 0.6 microgram/ml. Topical application of 5% lidocaine gel relieves PHN pain by a direct drug action on painful skin.
Acute otitis media (AOM) is common in children, yet the optimal management of ear pain associated with AOM has not been well studied. We set out to determine the efficacy of topical aqueous 2% lignocaine eardrops compared with a placebo (saline) for pain relief of AOM in children.
Double-blind, randomised, placebo-controlled trial.
Tertiary children's hospital emergency department.
Children aged between 3 and 17 years with earache and AOM without evidence of perforation were eligible. Patients were randomised to receive either 2% lignocaine or saline eardrops (placebo).
Pain scores were measured before and after ear-drop administration. Patient and physician-interpreted pain scores were measured by using the Bieri faces pain scale and visual analogue scale at 10, 20 and 30 minutes. The primary outcome measure was reduction in patient-measured pain scores by 50% from the baseline. Secondary outcome measures were reduction in patient-measured pain scores by 25% or by at least two points. Telephone follow-up occurred after 1 day and 1 week. Analysis was by intention to treat.
63 children (31 were treated with lignocaine, 32 with placebo) aged 3 to 12 years were enrolled. The groups were demographically and clinically similar, with similar proportions having received analgesia in the preceding 4 hours. Children receiving lignocaine showed significantly lower patient-measured pain scores with a reduction by 50% from baseline at 10 minutes (RR 2.06, 95% CI 1.03-4.11, p = 0.03) and 30 minutes (RR 1.44, 95% CI 1.07-1.93, p = 0.009) but not at 20 minutes (RR 1.35 95% CI 0.88-2.06). The response to lignocaine treatment showed significantly lower patient-measured pain scores for 25% reduction at all time points and for two-point reduction at 10 minutes and favoured lignocaine at 20 minutes and 30 minutes without reaching statistical significance. There were no serious adverse events during the 30 minute follow-up period.
This study suggests that topical aqueous 2% lignocaine eardrops provide rapid relief for many young children presenting with ear pain attributed to AOM. The concurrent use of simple oral analgesia is a likely contributor to effective management of this painful childhood condition.
The objective of the study was to determine if the addition of topical antibiotic increases the efficacy of topical steroid in controlling otitis externa. A double-blind randomised controlled trial was performed from February 2003 to April 2005 in an otolaryngology emergency clinic (acute urban teaching hospital) in the United Kingdom. Patients were followed up for 2 weeks. Forty-five adults with otitis externa based on the presence of oedema, discharge or debris in the outer ear canal were recruited. The patients were randomised to one of the two treatment groups, namely using betamethasone sodium phosphate 0.1% (Vista-Methasone) or betamethasone sodium phosphate 0.1% with neomycin sulphate 0.5% (Vista-Methasone N), and were instructed to use the trial medication at three drops three times a day for 2 weeks. Subjects' visual analogue symptom scores (blockage, pain, discharge, and itching) for otitis externa pre-treatment (day 0) and post-treatment (day 15), percentage changes in visual analogue symptom scores as a result of treatment, proportion of patients whose symptom scores failed to improve or deteriorated on treatment were analysed. The two experimental arms demonstrated statistically similar presenting symptom scores at recruitment (mean symptom scores of 19.2 for betamethasone group and 28.7 for betamethasone-neomycin group). The mean symptom score change in response to treatment was 82.8 and 47.8% in the betamethasone-neomycin and betamethasone-alone groups, respectively. There was no statistically significant difference between the groups in median percentage symptom score change in response to treatment. All patients in the betamethasone-neomycin group showed symptom improvement but in the betamethasone alone group, five patients got worse (Fishers exact, P = 0.05). Topical antibiotic-steroid combination therapy is superior to steroid-alone treatment for symptomatic control of otitis externa.
Introduction: Otomycosis is a common condition encountered in ENT practice. Though it is not a serious condition it causes a lot of misery to the patient. Though there are many studies on various aspects about this disease, there are not many studies from this part of the country. Materials and Methods: 75 patients attending ENT OPD and diagnosed to have otomycosis were included in the study. Two aural swabs or whenever possible otomycotic debris scooped out using Jobson –Horne probe was obtained. From one swab, wet mount preparation in 10% KOH (potassium hydroxide) solution and smear for Grams stain were prepared. The second swab / otomycotic debris was directly inoculated into SDA (sabourad’s dextrose agar) medium. Results: Mycological analysis of the swab from external auditory canal showed that Aspergillus species was the most common fungus isolated followed by Candida species. All patients were treated with regular suction clearance and 1% clotrimazole ear drops. Conclusion: avoiding usage of ear buds/ unsterile material will help in prevention of otomycosis. 1% clotrimazole is effective in achieving complete mycological cure in otomycosis. Regular long term follow-up is required to effectively treat otomycosis.
Otitis externa is a common ear inflammatory condition, usually caused by infection, and affecting up to 10% of the population. It is especially common in children, and is more likely to occur in those who are frequently exposed to water. Cleaning the affected area, the application of topical agents and prevention are the cornerstones of treatment. This article will review the different types of otitis externa and treatment options.
Question:
In the summer months I see many children with uncomplicated acute otitis externa (AOE). I am aware of the multiple ototopical preparations. Which is the best first-line agent to treat AOE, and is there a role for an oral antibiotic?
Answer:
There are no specific Canadian guidelines for the management of AOE. However, current American guidelines promote initial ototopical therapy without systemic antibiotics for uncomplicated AOE; suggest there is little difference between the various ototopical preparations; and recommend the choice of treatment be based on the specific clinical situation. In practice, this often results in prescribing an antibiotic-steroid formulation for 7 to 10 days. This ototopical treatment option is supported by a recent Cochrane review that has documented the superiority of an antibiotic-steroid combination when compared with placebo or acetic acid in providing clinical resolution of AOE.
This guideline provides evidence-based recommendations to manage diffuse acute otitis externa (AOE), defined as generalized inflammation of the external ear canal, which may also involve the pinna or tympanic membrane. The primary purpose is to promote appropriate use of oral and topical antimicrobials and to highlight the need for adequate pain relief.
In creating this guideline, the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) selected a development group representing the fields of otolaryngology-head and neck surgery, pediatrics, family medicine, infectious disease, internal medicine, emergency medicine, and medical informatics. The guideline was created with the use of an explicit, a priori, evidence-based protocol.
The group made a strong recommendation that management of AOE should include an assessment of pain, and the clinician should recommend analgesic treatment based on the severity of pain. The group made recommendations that clinicians should: 1) distinguish diffuse AOE from other causes of otalgia, otorrhea, and inflammation of the ear canal; 2) assess the patient with diffuse AOE for factors that modify management (nonintact tympanic membrane, tympanostomy tube, diabetes, immunocompromised state, prior radiotherapy); and 3) use topical preparations for initial therapy of diffuse, uncomplicated AOE; systemic antimicrobial therapy should not be used unless there is extension outside of the ear canal or the presence of specific host factors that would indicate a need for systemic therapy. The group made additional recommendations that: 4) the choice of topical antimicrobial therapy of diffuse AOE should be based on efficacy, low incidence of adverse events, likelihood of adherence to therapy, and cost; 5) clinicians should inform patients how to administer topical drops, and when the ear canal is obstructed, delivery of topical preparations should be enhanced by aural toilet, placing a wick, or both; 6) when the patient has a tympanostomy tube or known perforation of the tympanic membrane, the clinician should prescribe a nonototoxic topical preparation; and 7) if the patient fails to respond to the initial therapeutic option within 48 to 72 hours, the clinician should reassess the patient to confirm the diagnosis of diffuse AOE and to exclude other causes of illness. And finally, the panel compiled a list of research needs based on limitations of the evidence reviewed.
This clinical practice guideline is not intended as a sole source of guidance in evaluating patients with AOE. Rather, it is designed to assist clinicians by providing an evidence-based framework for decision-making strategies. It is not intended to replace clinical judgment or establish a protocol for all individuals with this condition and may not provide the only appropriate approach to the diagnosis and management of this problem.
This is the first, explicit, evidence-based clinical practice guideline on acute otitis externa, and the first clinical practice guideline produced independently by the AAO-HNSF.
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