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Trials volume 17Article number: Cite this article. Metrics details. While OME usually resolves spontaneously, it can affect speech, behaviour and development. Children with persistent hearing loss associated with OME are usually offered hearing aids or insertion of ventilation tubes through the tympanic membrane. Oral steroids may be a safe and effective treatment for OME, which could be delivered in primary care. Treatment with oral steroids has the potential to benefit large numbers of children and reduce the burden of care on them and on health services.
However, previous trials have either been too small with too short a follow-up period, or of too poor quality to give a definite answer. A total of participants children of 2 to 8 years of age are recruited from Hospital Ear, Nose and Throat departments in Wales and England.
A trained clinician seeks informed consent from parents of children with symptoms for at least 3 months that are attributable to OME and with confirmed bilateral hearing loss at study entry.
Participants are randomised to a course of oral steroid or a matched placebo for 1 week. Outcomes include audiometry, tympanometry and otoscopy assessments; symptoms; adverse effects; functional health status; quality of life; resource use; and cost effectiveness. Participants are followed up at 5 weeks, and at 6 and 12 months after the day of randomisation.
The primary outcome is audiometry-confirmed satisfactory hearing at 5 weeks. An important evidence gap exists regarding the clinical and cost effectiveness of short courses of oral steroid treatment for OME. Identifying an effective, safe, nonsurgical intervention for OME in children for use in primary care would be of great benefit to children, their families and the NHS.
Peer Review reports. This may affect other family members and family function. OME in early childhood can affect IQ, behaviour and reading into teenage years [ 3 ]. Treatment options for these children are limited to hearing aids or surgical insertion of ventilation tubes grommets through the tympanic membrane.
Hearing aids are an effective treatment, but this intervention is not problem-free; children often find them uncomfortable, may feel self-conscious and may become a target for bullying [ 5 ]. Furthermore, a wide variation exists in the rate of grommet surgery among regions, which is unlikely to be explained by variation in the disease. In Wales, a six-fold variation exists in the European age-standardised rates of grommet surgery between the highest and the lowest local authorities [ 7 ].
Both hearing aids and surgery require referral to secondary care, with major cost consequences. This position has been challenged. Deafness Research UK and the ENT UK Position Paper conclude that reducing access to grommets will disadvantage thousands of children who have a genuine need of treatment [ 910 ]. Antibiotics, topical intranasal steroids, decongestants, antihistamines and mucolytics are all ineffective treatments for OME [ 11 — 13 ]. A rigorous evaluation of anti-inflammatory treatment for OME has been a priority for many years [ 14 ].
Cochrane systematic reviews have found insufficient evidence for the effectiveness of both oral steroids and autoinflation AI devices in resolving OME in children to recommend implementation but sufficient evidence to recommend further research [ 12 ]. A recent trial of an AI device in children with OME and 4 to 11 years of age found a modest effect for some children [ 15 ].
Therefore, alternatives to hearing aids or surgery for children less than 4 years of age who are unable to use an AI device are required. Williamson et al. Topical steroids applied through the nose would not be expected to reach the middle ear. However, systemic steroids do reach the middle ear epithelium and modulate OME in animal models [ 17 ].
The evidence from in vitro and animal models suggests that steroids reduce effusions and middle ear pressure [ 18 — 21 ]. Various mechanisms have been proposed for a role for steroids in resolving middle ear effusions, including a reducing arachidonic acid and associated inflammatory mediators, b shrinking peri-eustachian tube lymphoid tissue, c enhancing secretion of eustachian tube surfactant with a resultant improvement in tubal function, and d reducing middle ear fluid viscosity by its action on mucoproteins [ 22 ].
The latest update of the Cochrane review on oral or topical steroids for OME last search August found no benefit from intranasal steroids [ 12 ].
Oral antibiotics alone are not effective. The only study to assess the effect of oral steroids on hearing as an outcome was underpowered.
No cost effectiveness studies of oral steroids for OME were found. Therefore, insufficient evidence exists to recommend oral steroids as a treatment for persistent OME because of inadequate evidence about short-term effect on hearing and cost-effectiveness, and absence of evidence about longer-term effects.
No significant adverse effects of steroids were reported by the studies included in the Cochrane review. However, the number of participants was too small to rule out that possibility. Short courses of prednisolone are widely used in treating children with acute asthma, and adverse events are extremely rare; when they do occur, they are largely limited to behavioural disturbances and dyspepsia and resolve on withdrawal of the steroid drug. The safety of multiple short courses of oral steroid therapy has been evaluated [ 23 ].
Short courses of oral steroids such as prednisolone do not have lasting negative effects on bone metabolism, bone density, adrenal gland function or weight or height, even if used on several occasions over the course of a year [ 24 ].
Identifying an effective, safe, cost-effective, acceptable non-surgical intervention for OME in children including those in the first 4 years of life for use in primary care remains an important research priority.
The primary objective of the OSTRICH trial is to determine the clinical and cost effectiveness of a 7-day course of oral steroid on improving hearing at 5 weeks from randomisation in children with bilateral OME, who have had symptoms attributable to OME present for at least 3 months and have current significant hearing loss demonstrated by audiometry. Oral steroids are likely to have their effect within the first few weeks, and most of the existing evidence is for an effect at 4 to 6 weeks.
This is, therefore, the time point at which the maximum effect is expected. It will randomise children 2 to 8 years of age to receive a 1-week course of oral prednisolone or a matching placebo. All participants are followed up at 5 weeks, 6 months and 12 months after the day of randomisation. This trial is implemented in secondary care sites across Wales and England. Children 2 to 8 years old with symptoms of hearing loss for at least 3 months attributed to OME are eligible to join the trial if they meet the following inclusion criteria.
Age 2 to 8 years for example, has reached the 2 nd birthday and has not yet reached the 9 th birthday. Symptoms of hearing loss attributable to OME for at least 3 months or had audiometry proven hearing loss for at least 3 months. Audiometry confirming hearing loss of more than 20 dBHL averaged within the frequencies of 0. Confirmed, major developmental difficulties for example, are tube fed or have chromosomal abnormalities. Has a condition that increases their risk of adverse effects from oral steroids that is, on treatment, the immune system is likely to be modified, or are immunocompromised, such as undergoing cancer treatment.
Has been in close contact with someone known or suspected to have Varicella chicken pox or active Zoster shingles during the 3 weeks prior to recruitment and have no prior history of Varicella infection or immunisation.
On a waiting list for grommet surgery and anticipate having surgery within 5 weeks and are unwilling to delay it. Participants randomised to the active treatment arm receive a 7-day course of oral soluble Prednisolone, as a single daily dose of 20 mg for children 2 to 5 years of age or 30 mg for 6- to 8-year olds.
The daily dose stated is the most commonly used dose in previous studies of OME and is similar to the standard dose for the treatment of other conditions with inflammatory components such as asthma. Participants randomised to the control arm receive a 7-day course of oral placebo. This is matched for consistency, colour and solubility, as well as visually, in identical packaging to the active treatment.
These thresholds are based on national guidelines [ 25 ]. The secondary outcomes assess the longer term up to 12 months effects of the intervention on the following:.
Tympanometry using calibrated standardised tympanometers and modified Jerger classification Types A, B and C. Trial sites are selected on the basis of their recruitment potential and being part of a well-established clinical research network.
All sites receive training in trial-specific procedures and good clinical practice GCP. The training materials are designed specifically to train different staff groups, depending on their roles and responsibilities.
For example, the Principal Investigator PI and designated trial clinicians are trained on trial-specific tasks including assessing eligibility, taking informed consent and prescribing.
OSTRICH nurses term used in this protocol to refer to clinic nurse, research nurse or clinical studies research officer are trained in registration, data collection, and handling of the trial medication. Pharmacy staff members are trained in Investigational Medicinal Product IMP management procedures, such as storing, allocating and dispensing, as well as temperature monitoring and reconciliation for each randomised patient.
Designated staff members are responsible for cascading training and delegating specific Protocol tasks to other trial site staff. The recruitment process is summarised in Fig. Participating clinicians ENT or Audiovestibular Medicine identify eligible patients with bilateral hearing loss and diagnosis of OME during routine outpatient consultations, from current grommet surgery waiting lists or from hearing aid review lists. Each child has an audiometry assessment and a clinical assessment both routine procedures for those attending these clinics before they are assessed for eligibility to enter the trial.
Age-appropriate pictorial information sheets are also be provided for children who are old enough to use them.
Assent may be given by children who are able to understand the age-appropriate information provided and express an opinion regarding their participation. These are used to measure potential selection bias.
Whether the allocations relate to the steroid or placebo was determined by an independent statistician to ensure the TS remains blinded. The allocation numbers are used to label the trial medication packs. Each trial medication pack has a unique identification number Trial Pack number. Trial medication packs are only released once informed consent has been obtained and a consent form signed. Participants are randomised to receive either the steroid or the matching placebo by receiving the next sequentially numbered Trial Pack allocated to the participant by the site Pharmacy.
Participant randomisation is considered to have occurred once a consent form is signed and the Trial Pack opened. The unique identification number on each Trial Pack is linked to the randomisation schedule. An eligibility case report form CRF is completed for all consented participants to ensure that they meet the eligibility criteria specified in the trial protocol. The clinician signs the form to confirm that the participant is eligible to be enrolled into the trial.
Table 1 provides an explanation of the clinical assessments of this trial. In current practice, the recommended standard methods to assess hearing thresholds are ear-specific pure tone audiometry PTA at 0. However, equally, those children under 3 years of age may comply with PTA. In the first week, this is completed daily to record treatment adherence. Completion of the questionnaire booklets and the clinical assessments for example, audiometry, tympanometry, and otoscopy are repeated at each of the follow-up clinic appointments.
In the event that telephone contact is not successful, visit reminder letters are sent to rearrange the appointment. OME resolves spontaneously in a high proportion of children, and some studies have found a significantly higher rate of spontaneous resolution. For example, Williamson et al. However, we anticipate a lower spontaneous rate of resolution because we will only include children who have been symptomatic for at least 3 months and are recruiting children in a secondary care setting, where a more severe spectrum of illness can be anticipated.
We have selected a conservative estimate of 1.
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Prednisone for ear fluid.Prednisolone ear drops
The primary outcome is audiometry-confirmed satisfactory hearing at 5 weeks. An important evidence gap exists regarding the clinical and cost effectiveness of short courses of oral steroid treatment for OME. Identifying an effective, safe, nonsurgical intervention for OME in children for use in primary care would be of great benefit to children, their families and the NHS. Peer Review reports. This may affect other family members and family function.
OME in early childhood can affect IQ, behaviour and reading into teenage years [ 3 ]. Treatment options for these children are limited to hearing aids or surgical insertion of ventilation tubes grommets through the tympanic membrane.
Hearing aids are an effective treatment, but this intervention is not problem-free; children often find them uncomfortable, may feel self-conscious and may become a target for bullying [ 5 ]. Furthermore, a wide variation exists in the rate of grommet surgery among regions, which is unlikely to be explained by variation in the disease. In Wales, a six-fold variation exists in the European age-standardised rates of grommet surgery between the highest and the lowest local authorities [ 7 ].
Both hearing aids and surgery require referral to secondary care, with major cost consequences. This position has been challenged. Deafness Research UK and the ENT UK Position Paper conclude that reducing access to grommets will disadvantage thousands of children who have a genuine need of treatment [ 9 , 10 ]. Antibiotics, topical intranasal steroids, decongestants, antihistamines and mucolytics are all ineffective treatments for OME [ 11 — 13 ].
A rigorous evaluation of anti-inflammatory treatment for OME has been a priority for many years [ 14 ]. Cochrane systematic reviews have found insufficient evidence for the effectiveness of both oral steroids and autoinflation AI devices in resolving OME in children to recommend implementation but sufficient evidence to recommend further research [ 12 ].
A recent trial of an AI device in children with OME and 4 to 11 years of age found a modest effect for some children [ 15 ]. Therefore, alternatives to hearing aids or surgery for children less than 4 years of age who are unable to use an AI device are required.
Williamson et al. Topical steroids applied through the nose would not be expected to reach the middle ear. However, systemic steroids do reach the middle ear epithelium and modulate OME in animal models [ 17 ]. The evidence from in vitro and animal models suggests that steroids reduce effusions and middle ear pressure [ 18 — 21 ].
Various mechanisms have been proposed for a role for steroids in resolving middle ear effusions, including a reducing arachidonic acid and associated inflammatory mediators, b shrinking peri-eustachian tube lymphoid tissue, c enhancing secretion of eustachian tube surfactant with a resultant improvement in tubal function, and d reducing middle ear fluid viscosity by its action on mucoproteins [ 22 ].
The latest update of the Cochrane review on oral or topical steroids for OME last search August found no benefit from intranasal steroids [ 12 ]. Oral antibiotics alone are not effective. The only study to assess the effect of oral steroids on hearing as an outcome was underpowered. No cost effectiveness studies of oral steroids for OME were found. Therefore, insufficient evidence exists to recommend oral steroids as a treatment for persistent OME because of inadequate evidence about short-term effect on hearing and cost-effectiveness, and absence of evidence about longer-term effects.
No significant adverse effects of steroids were reported by the studies included in the Cochrane review. However, the number of participants was too small to rule out that possibility. Short courses of prednisolone are widely used in treating children with acute asthma, and adverse events are extremely rare; when they do occur, they are largely limited to behavioural disturbances and dyspepsia and resolve on withdrawal of the steroid drug.
The safety of multiple short courses of oral steroid therapy has been evaluated [ 23 ]. Short courses of oral steroids such as prednisolone do not have lasting negative effects on bone metabolism, bone density, adrenal gland function or weight or height, even if used on several occasions over the course of a year [ 24 ]. Identifying an effective, safe, cost-effective, acceptable non-surgical intervention for OME in children including those in the first 4 years of life for use in primary care remains an important research priority.
The primary objective of the OSTRICH trial is to determine the clinical and cost effectiveness of a 7-day course of oral steroid on improving hearing at 5 weeks from randomisation in children with bilateral OME, who have had symptoms attributable to OME present for at least 3 months and have current significant hearing loss demonstrated by audiometry.
Oral steroids are likely to have their effect within the first few weeks, and most of the existing evidence is for an effect at 4 to 6 weeks. This is, therefore, the time point at which the maximum effect is expected. It will randomise children 2 to 8 years of age to receive a 1-week course of oral prednisolone or a matching placebo.
All participants are followed up at 5 weeks, 6 months and 12 months after the day of randomisation. This trial is implemented in secondary care sites across Wales and England. Children 2 to 8 years old with symptoms of hearing loss for at least 3 months attributed to OME are eligible to join the trial if they meet the following inclusion criteria.
Age 2 to 8 years for example, has reached the 2 nd birthday and has not yet reached the 9 th birthday. Symptoms of hearing loss attributable to OME for at least 3 months or had audiometry proven hearing loss for at least 3 months. Audiometry confirming hearing loss of more than 20 dBHL averaged within the frequencies of 0.
Confirmed, major developmental difficulties for example, are tube fed or have chromosomal abnormalities. Has a condition that increases their risk of adverse effects from oral steroids that is, on treatment, the immune system is likely to be modified, or are immunocompromised, such as undergoing cancer treatment.
Has been in close contact with someone known or suspected to have Varicella chicken pox or active Zoster shingles during the 3 weeks prior to recruitment and have no prior history of Varicella infection or immunisation.
On a waiting list for grommet surgery and anticipate having surgery within 5 weeks and are unwilling to delay it. Participants randomised to the active treatment arm receive a 7-day course of oral soluble Prednisolone, as a single daily dose of 20 mg for children 2 to 5 years of age or 30 mg for 6- to 8-year olds.
The daily dose stated is the most commonly used dose in previous studies of OME and is similar to the standard dose for the treatment of other conditions with inflammatory components such as asthma. Participants randomised to the control arm receive a 7-day course of oral placebo. This is matched for consistency, colour and solubility, as well as visually, in identical packaging to the active treatment. These thresholds are based on national guidelines [ 25 ]. The secondary outcomes assess the longer term up to 12 months effects of the intervention on the following:.
Tympanometry using calibrated standardised tympanometers and modified Jerger classification Types A, B and C. Trial sites are selected on the basis of their recruitment potential and being part of a well-established clinical research network. All sites receive training in trial-specific procedures and good clinical practice GCP.
The training materials are designed specifically to train different staff groups, depending on their roles and responsibilities. For example, the Principal Investigator PI and designated trial clinicians are trained on trial-specific tasks including assessing eligibility, taking informed consent and prescribing. Topical nasal steroids fluticasone, plus many others and oral antihistamines loratadine, plus many others may be used to treat allergies.
Ear tubes small tubes that are place into the tympanic membrane directly equalize the pressure and drain the fluid behind the ear drum. This procedure may be performed in the office for adult patients. Balloon dilation of the Eustachian tube is a relatively new treatment for ETD. We will not discuss intravenous administration faster and stronger, sometimes used for situations where symptoms are very severe such as bilateral deafness associated with autoimmune inner ear disease.
Administration through the ear-drum is discussed elsewhere. This method has the advantage of much less side effects, but the disadvantages of higher expense and the need for a subspecialty visit for injection through the ear drum. For the oral method, there are four common protocols that we use in our clinic :.
The easiest, safest, and most convenient method of trying steroids is to use a medrol methylprednisolone dose pack. This is a card that contains 6 days of steroids, with less provided each day. The gradual decrease in the amount of steroids each day is called a "taper".
The reason to do this is to allow the patient's adrenal glands, which are usually suppressed by the steroids, to gradually return to supplying steroids to the patient on their own. Medrol is slightly stronger than prednsone, so to convert this into "prednisone", when using the 4 mg dose-pack, one just has to multiple by 5.
In other words, the medrol dose pack is the equivalent of 30 mg of prednisone, tapering down to 0 over a week. For persons in whom a larger amount of steroids is indicated a longer protocol and more intense protocol is selected. Longer pulses require longer tapers. Checking the blood pressure to make sure it is not dropping too low and follow up visits during the taper period are often required.
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?
ETD occurs when there is a dysfunction of the Eustachian tube. This condition prevents the release of pressure and fluid from the middle space the space behind the tympanic membrane or ear drum. It can occur during common colds, upper respiratory tract infections, allergies, impeded nasal airflow or chronic drainage of mucus on the tube opening.
The Eustachian Tube ET is a small passage way that connects the middle ear to the nasopharynx. The tube function to equalize the pressure between the ear and the surrounding environment.
Therefore it helps prevent pressure and fluid from building up inside the ears. ETD can be diagnosed through a thorough head and neck examination. The physician will look in the ears to see the eardrum and into the nasal cavity.
On many occasion, a good history can diagnose the condition as well. There are several treatment options for ETD ranging from simple to more invasive. What is the Eustachian tube? What are the symptoms of ETD? How is it treated?
Topical nasal steroids fluticasone, plus many others and oral antihistamines loratadine, plus many others may be used to treat allergies. Ear tubes small tubes that are place into the tympanic membrane directly equalize the pressure and drain the fluid behind the ear drum.
This procedure may be performed in the office for adult patients. Balloon dilation of the Eustachian tube is a relatively new treatment for ETD.
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. Conclusions Steroids alone or combined with an antibiotic lead to a quicker resolution of OME in the short-term. However, there is no evidence for a long-term. 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. The glucocorticoids, prednisolone and dexamethasone, were the most effective in our study in reducing middle ear inflammation in response to bacterial challenge. Steroids are commonly prescribed for sudden hearing loss as well as for autoimmune inner ear disease and vestibular neuritis. A rigorous evaluation of anti-inflammatory treatment for OME has been a priority for many years [ 14 ]. A recent trial of an AI device in children with OME and 4 to 11 years of age found a modest effect for some children [ 15 ]. Participants randomised to the control arm receive a 7-day course of oral placebo. 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? 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.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. Anti-inflammatory ear drops close.
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