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RACGP - Oral corticosteroids for painful acute otitis externa. |
Prednisone for ear infection.Corticosteroid Therapy for Inner Ear Disorders
It is a common problem for which patients present to general practitioners GPsparticularly in coastal temperate and tropical climates. Its monthly incidence in the USA increases during the summer season from 0. However, in tropical parts of Australia the annual incidence is likely to be much higher than 1.
The skin in the external ear canal of a healthy ear has a thin protective coating of cerumen, a mixture of secretions from apocrine and sebaceous glands mixed with desquamated epithelial cells. An infectious organism cannot be found in at least one-third of patients with otitis externa.
A secondary infection is likely in severe cases, and common organisms found are Pseudomonas spp. Common consequences for patients with otitis externa are pain, sleep disturbance, temporary loss of hearing, pharmaceutical and consultation expenses, and potentially loss of income. Initial symptoms at presentation to medical practices range from mild irritation with almost no pain to the strongest pain imaginable as measured by a pain scale.
As well as pain, other consequences are costs for healthcare and sometimes also loss of productivity. Most patients fully recover after 5—14 days. Infection may also spread to deeper structures such as the inner ear and the brain, which can be potentially life-threatening.
The treatment for otitis externa is usually topical; in selected cases, oral antibiotics are prescribed. Prednisone or prednisolone is used in doses ranging from 20 to 75 mg daily for 3—5 days. Corticosteroids reduce the immune response. Therefore, corticosteroids given to a patient who has a severe infection could theoretically be detrimental. However, it has previously been shown that corticosteroids can be given safely and with beneficial effect to patients with ongoing infection of low or moderate virulence.
Examples are patients with croup 14 and sore throat. Acute otitis externa is in most cases either an aseptic inflammation that is simultaneously colonised by bacteria, or an infection of low-to-moderate virulence.
In these situations, corticosteroids could theoretically be beneficial. Current evidence indicates that a topical steroid is beneficial to patients with otitis externa. We were unable to identify a published clinical trial evaluating the effect of oral corticosteroids in patients with otitis externa. Giving oral corticosteroids to patients with otitis externa could be beneficial or harmful.
It may be that oral corticosteroids in the lower dose range are beneficial while using higher doses could add side effects and risks without benefit. If a short course of low-dose oral corticosteroids 20 mg prednisone daily is beneficial, then this finding is useful for practitioners currently prescribing a higher dose. If a benefit of oral corticosteroids is not proven, then physicians currently prescribing it need to be advised of this finding.
The objective of this study was to assess the efficacy of low-dose oral prednisolone for four days in addition to conventional therapy in the management of painful acute otitis externa.
Primary research questions and subsequent data collection aimed to comply with the only published validated questionnaire for acute otitis externa. Sixteen primary healthcare centres and 19 adjacent pharmacies in tropical Far North Queensland, Australia, agreed to participate. Consecutive patients attending participating primary healthcare centres for otitis externa were asked by the medical practitioner if they accepted screening in relation to inclusion criteria:.
Patients fulfilling all inclusion criteria were referred to one of the participating pharmacies, where further information was given, consent forms were signed and the study medication was dispensed. A website was created as an ongoing resource for GPs and pharmacists www. Furthermore, GP clinics and pharmacies were visited regularly to ensure they adhered to the agreed study protocol. Age, gender, ethnicity and initial ear pain was noted at baseline. Initial ear pain was measured using a VAS of 10 cm Figure 1.
The VAS, subsequent diary and final survey after symptom resolution or up to 10 days after enrolment adhered to the validated VAS, diary and survey published by Shikiar et al in Figure 1. Visual analogue scale.
Randomisation was achieved using random numbers generated by the ResearchRandomizer website www. Medical practitioners, participating pharmacists, patients, staff telephoning patients and the person doing statistical analysis were all unaware of group allocation.
The pharmacist checked inclusion criteria for a second time and provided study tablets to patients accepting participation. The intervention was a study capsule taken twice daily for four days in addition to any other treatment prescribed by the medical practitioner. Capsules with the active ingredient contained 10 mg of prednisone packed in an opaque gelatine capsule.
The remaining space was filled with lactose. Capsules with placebo contained lactose packed in a gelatine capsule which was identical in appearance to capsules with the active ingredient. The lactose content was considered insignificant for patients with lactose intolerance.
All patients fulfilling inclusion criteria and with data available were analysed as follows:. The analysis was done as intention to treat. Intention to treat was defined as all patients fulfilling the inclusion criteria with follow-up data available, making analysis possible irrespective of whether they adhered to the allocated treatment arm.
Imputation of data for patients lost to follow-up was not made. Sample size calculations were based on the primary research questions and made two-tailed to avoid the assumption that a difference between groups would always favour the intervention group. Sample size calculations for survival analysis used the statistical software PASS version We calculated that patients would be sufficient to answer all primary research questions. We expected that some patients would be lost to follow-up so we aimed to include patients.
A more detailed description of the sample size calculation is described in the full study protocol. Patients with any type of side effect mentioned above were instructed in the written information to immediately contact their GP or nearest emergency department if their GP was unavailable. The patient information also outlined that those patients must immediately stop taking the study tablets.
Furthermore, they were instructed to notify the steering committee. Patients were also withdrawn from the study if it was their wish. Detailed rules for discontinuation of the study are presented in the study protocol. The funder, Cairns Hospital Foundation, did not participate in planning, analysing data or writing of the manuscript.
One hundred and sixty-four patients were screened for eligibility between 28 October and 19 June Seventy-three patients were randomised and given instructions with surveys to return and a can containing the study tablets. Forty-three of these patients could not be analysed, while 30 patients submitted identifiable surveys and were included in the final analysis Figure 2. Figure 2. This study did not find evidence that the intervention and control groups differed statistically at baseline Table 1.
Two patients in the intervention group stated they took only 3—4 out of eight study tablets. No reason for this was given. All other patients included in the final analysis stated they took all eight study tablets. It took an average of 5. Lost hours as a result of otitis externa were similar in both groups Table 2.
Side effects during treatment were expected and similar in both groups Table 3. None of these revisits were considered unexpected or serious, and all four patients became completely pain-free in an average of 4. No patient was excluded as a result of worsening of symptoms. The influence of ethnicity was not analysed because most patients were of Caucasian ethnicity Table 1. Patient satisfaction after treatment was similar in both groups Table 3.
It took an average of 3. However, oral corticosteroids did not reduce the time to reporting being completely pain-free complete resolution of pain. The main limitations of this study were recruitment of participants and loss to follow-up of included participants. Recruitment was slower than anticipated, and fewer than half of the patients who were screened were suitable for inclusion. The target was never reached: after 20 months of recruiting, the study was terminated because of slow recruitment of patients.
Fewer than half of the randomised patients returned identifiable surveys. The following potential problems were identified:. A formal process evaluation 24 to see if further lessons could be learnt was not done because of lack of funding. Clinical follow-up by the medical practitioner on days three and six would have added useful information. However, this would have required substantial funding that was not available. This study was planned as a randomised controlled trial RCT but, most likely because of insufficient funding, failed to recruit enough patients to be adequately powered to assess the proposed outcomes.
However, the study indicates that the measuring tools worked well, the intervention was accepted by patients and the sample size calculation is likely to be adequate. Although we did not plan this to be a pilot study, and it should be classified as an underpowered RCT, our outcomes are useful to inform a larger study in a similar manner to a pilot study. Therefore, these potentially interesting results should be confirmed in a larger, properly funded clinical trial before applying the results in the routine healthcare setting.
Shortening the duration of intense pain by 1. Therefore, pursuing this research with a follow-up study adequately powered to measure complete resolution of pain as an outcome makes sense. However, for a larger study to be feasible, reasonable funding for reimbursement for healthcare providers and participating patients is likely to be required. A future study with a larger number of patients available for statistical analysis could also investigate the extent to which the effect of oral corticosteroids is influenced by baseline pain, sleep disturbance due to symptoms, occlusion of the ear canal or initial cleaning of the ear canal using suction under microscope.
Did you know you can now log your CPD with a click of a button? Background and objectives Acute otitis externa is often painful. The aim of this study was to evaluate the efficacy of 10 mg oral prednisolone twice daily for four days in addition to conventional therapy.
Methods Patients attending general practice clinics in Far North Queensland, Australia, for acute painful otitis externa were given a study capsule with either 10 mg prednisone or placebo. Results Seventy-three patients were randomised. Results from 19 patients in the intervention group and 11 patients in the control group were analysed.
❿Prednisone for ear infection. Prednisolone ear drops
Jump to navigation. We reviewed the evidence on the effects of corticosteroids given by mouth or injection for acute middle ear infection acute otitis media AOM in children, particularly in improving symptoms such as ear pain, fever, irritability, lack of sleep, and lack of appetite.
We also looked at the side effects of corticosteroids. Acute otitis media is common in children and causes ear pain and non-specific symptoms such as fever, irritability, and deafness. It is often treated with antibiotics, although ear pain generally resolves within two days, and antibiotics help symptoms only slightly. Other treatments such as over-the-counter antihistamines and decongestants do not help very much.
Corticosteroids are often prescribed to reduce inflammation in children for other illnesses, and so may also help symptoms of AOM, which is an inflammatory process. We investigated whether using corticosteroids was better or worse than nothing in improving AOM-related symptoms.
We included two studies involving children with AOM, aged from three months to six years, receiving hospital ambulatory care. Children were treated with an antibiotic injection and either oral corticosteroid or a placebo treatment with no effect.
In one study, fluid from the middle ear was collected by inserting a needle through the eardrum to measure the level of inflammation. Pharmaceutical companies provided the drug but did not contribute any other scientific or financial support. Corticosteroids did not make a significant difference in improving the symptoms and inflammation of the eardrum s at Day 5 and Day 14, but we are unsure of this effect due to the small numbers of children in the studies.
There were no significant differences between the corticosteroid and placebo groups in terms of resolving fluid in children's middle ears at 1, 2, and 3 months and experiencing new episodes of AOM at 1, 2, 3 months, and 4 and 6 months.
Neither study reported a reduction in the duration of overall or specific symptoms, rupture of eardrum sthe occurrence of middle ear inflammation in the other ear following the current ear infection, or serious complications. Only one study reported the overall side effects identified during the trial e.
The quality of evidence included in this review was low to very low due to few children included in two small studies. We are uncertain about whether or not corticosteroids are useful in relieving pain from AOM. The evidence for the effect of systemic corticosteroids on AOM is of low to very low quality, meaning the effect of systemic corticosteroids on important clinical outcomes in AOM remains uncertain.
Large, high-quality studies are required to resolve the question. Acute otitis media AOM is a common acute infection in children.
Pain is its most prominent and distressing symptom. Antibiotics are commonly prescribed for AOM, although they have only a modest effect in reducing pain at two to three days. There is insufficient evidence for benefits of other treatment options, including systemic corticosteroids. However, systemic corticosteroids are potent anti-inflammatory drugs, and so theoretically could be effective, either alone or as an addition to antibiotics. To assess the effects of systemic corticosteroids oral or parenteralwith or without antibiotics, for AOM in children.
We checked the reference lists of all primary studies and review articles for additional references and contacted experts in the field to identify additional unpublished materials.
We included randomised controlled trials of children with AOM that compared any systemic corticosteroid oral or parenteral with placebo, either with antibiotics corticosteroid plus antibiotic versus placebo plus antibiotic or without antibiotics corticosteroid versus placebo.
Three review authors EDS, RR, YP independently screened the titles and abstracts and retrieved the full texts of potentially relevant studies. We independently extracted study characteristics and outcome data from the included studies, and assessed the risk of bias for each study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions. We included two studies involving children with AOM aged from three months to six years receiving hospital ambulatory care who were treated with intramuscular ceftriaxone, and who were then randomised to the corticosteroid group corticosteroid and corticosteroid plus antihistamine or the placebo group antihistamine and double placebo.
In one study, children also had a needle aspiration of middle ear fluid. Both studies were at unclear risk of bias for allocation concealment, and unclear to high risk of bias for selective reporting. Low-quality evidence meant that we are uncertain of the effectiveness of corticosteroids for this outcome.
Children in the treatment group had more favourable outcomes adjusted odds ratio We were unable to pool the results with the other study because it did not report the proportion of children with this outcome by treatment group. Only one study reported adverse effects of corticosteroids e. Neither study reported a reduction in overall or specific symptom duration. Systemic corticosteroids for improving symptoms in children with acute middle ear infection Review question We reviewed the evidence on the effects of corticosteroids given by mouth or injection for acute middle ear infection acute otitis media AOM in children, particularly in improving symptoms such as ear pain, fever, irritability, lack of sleep, and lack of appetite.
Background Acute otitis media is common in children and causes ear pain and non-specific symptoms such as fever, irritability, and deafness. Search date Our evidence is current to 20 February Study characteristics We included two studies involving children with AOM, aged from three months to six years, receiving hospital ambulatory care. Key results and quality of evidence Corticosteroids did not make a significant difference in improving the symptoms and inflammation of the eardrum s at Day 5 and Day 14, but we are unsure of this effect due to the small numbers of children in the studies.
We could not draw any conclusions regarding the effects of corticosteroids for AOM in children. Authors' conclusions:.
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Drug information provided by: IBM Micromedex. Otic corticosteroids cortisone-like medicines are used in the ear to relieve the redness, itching, and swelling caused by certain ear problems. Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
There is no specific information about the use of otic corticosteroids in children. Children born to mothers taking otic corticosteroid therapy during their pregnancy should be observed for decrease in growth and for hypoadrenalism anorexia, low blood pressure, and weakness. Although there is no specific information about the use of otic corticosteroids in the elderly, they are not expected to cause different side effects or problems in older people than they do in younger adults.
Studies with otic corticosteroids have not been done in pregnant women. However, in animal studies, corticosteroids have been shown to cause birth defects.
Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant. Corticosteroids pass into breast milk. Be sure you have discussed the risks to the child and benefits of the medicine with your doctor. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur.
In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription over-the-counter [OTC] medicine. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur.
Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:. To keep the medicine as germ-free as possible, do not touch the dropper or applicator tip to any surface including the ear.
Also, keep the container tightly closed. Do not use corticosteroids more often or for a longer time than your doctor ordered. To do so may increase the chance of side effects.
Do not use any leftover medicine for future ear problems without first checking with your doctor. This medicine should not be used if certain kinds of infections are present. To do so may make the infection worse. The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines.
If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
Keep from freezing. If your condition does not improve within 5 to 7 days, or if it becomes worse, check with your doctor. While you are being treated with otic corticosteroids, and after you stop treatment, do not have any immunizations vaccinations without your doctor's approval. Otic corticosteroids may lower your body's resistance and there is a chance you might get the infection the immunization is trying to prevent.
In addition, other persons living in your household should not take or have recently taken oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid other persons who have taken oral polio vaccine.
Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:.
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. All rights reserved. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes.
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The glucocorticoids, prednisolone and dexamethasone, were the most effective in our study in reducing middle ear inflammation in response to bacterial challenge. This report presents findings of a double-blind crossover prospective study involving the use of a short course of prednisone for the treatment of otitis. Prednisolone ear drops are prescribed to treat inflammation in the ear canal. Use two to three drops every two or three hours to begin with. We reviewed the evidence on the effects of corticosteroids given by mouth or injection for acute middle ear infection (acute otitis media. If you have a viral inner ear infection, your doctor may prescribe a steroid treatment to reduce inflammation or antiviral medication to attack. While you are being treated with otic corticosteroids, and after you stop treatment, do not have any immunizations vaccinations without your doctor's approval. We could not draw any conclusions regarding the effects of corticosteroids for AOM in children. SD, standard deviation; VAS, visual analogue scale. I've always had issues with ear wax impaction We were unable to pool the results with the other study because it did not report the proportion of children with this outcome by treatment group.Use two to three drops every two or three hours to begin with, then reduce the frequency as your ear improves. If your symptoms have not improved after seven days, make another appointment to see your doctor. Otitis externa is a term used for inflammation in the ear when it is confined to the ear canal and does not go further than the eardrum. If you get things like water, shampoo or soap in your ear, then it can cause itching.
If you then scratch or poke your ear, this can damage the skin in the ear canal and cause inflammation. Prednisolone ear drops are used to relieve this type of inflammation, along with any associated itching and pain. To make sure this is the right treatment for you, before you start using prednisolone ear drops, it is important that your doctor knows:. You may get a slight feeling of irritation or burning.
This is usually mild and soon passes. If you get a rash or if you notice any other symptoms which you think may be due to the drops, ask your doctor or pharmacist for advice. If you suspect that someone has swallowed some of this medicine, go to the accident and emergency department of your local hospital. Take the container with you, even if it is empty. This medicine is for you. Never give it to other people even if their condition appears to be the same as yours.
If you are having an operation or dental treatment, tell the person carrying out the treatment which medicines you are using. Do not keep out-of-date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you.
If you buy any medicines, check with a pharmacist that they are safe to use with your other medicines. Dated June I've always had issues with ear wax impaction Disclaimer: This article is for information only and should not be used for the diagnosis or treatment of medical conditions. Egton Medical Information Systems Limited has used all reasonable care in compiling the information but make no warranty as to its accuracy. Consult a doctor or other health care professional for diagnosis and treatment of medical conditions.
For details see our conditions. Prednisolone ear drops are prescribed to treat inflammation in the ear canal. In this article About prednisolone ear drops Before using prednisolone ear drops How to use prednisolone ear drops Getting the most from your treatment Can prednisolone ear drops cause problems?
How to store prednisolone ear drops Important information about all medicines. Prednisolone ear drops In this article About prednisolone ear drops Before using prednisolone ear drops How to use prednisolone ear drops Getting the most from your treatment Can prednisolone ear drops cause problems? About prednisolone ear drops Type of medicine Anti-inflammatory ear drops Used for Inflammation in the outer parts of the ear otitis externa Also called Prednisolone sodium phosphate Available as Ear drops.
If you have any questions about this medicine ask your pharmacist. Are you protected against flu? Further reading and references. Join the discussion on the forums. Health Tools Feeling unwell? Assess your symptoms online with our free symptom checker. Start symptom checker. Notes on Prednisolone ear drops.
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