RACGP - Oral corticosteroids for painful acute otitis externa.Corticosteroid (Otic Route) Proper Use - Mayo Clinic
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It is a common problem for which patients present to general practitioners GPs , particularly 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.
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Drug information provided by: IBM Micromedex. 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. 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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Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. This site complies with the HONcode standard for trustworthy health information: verify here. This content does not have an English version. This content does not have an Arabic version. See more conditions. Drugs and Supplements Corticosteroid Otic Route. Products and services. Gently pull the earlobe up and back for adults down and back for children to straighten the ear canal.
Drop the medicine into the ear canal. Keep the ear facing up for several about 5 minutes to allow the medicine to run to the bottom of the ear canal. A sterile cotton plug may be gently inserted into the ear opening to prevent the medicine from leaking out. At first, your doctor may want you to put more medicine on the cotton plug during the day to keep it moist.
Prednisolone sodium phosphate. Prednisolone Sodium Phosphate Drops is used to treat inflammation of the eye or ear where there is no infection. 2. What you need to know before you use. Prednisolone Sodium Phosphate Drops is indicated for short term treatment of steroid responsive inflammatory conditions of the eye after clinical exclusion of. Otic steroids with anti-infectives are ear drops that have both steroids and anti-infectives. Steroids are effective anti-inflammatory agents and are used. To begin with, you should put two to three drops into the affected ear(s) every two to three hours while you're awake, usually for the first Age, gender, ethnicity and initial ear pain was noted at baseline.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. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. Mayo Clinic is a nonprofit organization and proceeds from Web advertising help support our mission.
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