Oral prednisolone for acute middle ear infection in children
Oral prednisolone for acute otitis media in children: a pilot pragmatic, randomised, open-label, single-blind study to evaluate feasibility
Respati Wulansari Ranakusuma
60 participants
Mar 8, 2018
Interventional
Conditions
Summary
Antibiotic resistance, a major health global threat, is mostly driven by antibiotic prescribing. Antibiotics are commonly prescribed in primary care for acute respiratory infections, including acute otitis media (AOM). AOM is an inflammation of the middle ear commonly found in children. Expectant observation with pain management is commonly recommended for children with mild AOM (e.g. mild ear pain, fever < 39°C) who can be reliably followed-up. Those with severe symptoms, bilateral AOM in young age children, or perforated ear drums are more likely to benefit from antibiotics. The option of using antibiotics must be balanced against common adverse effects (e.g. vomiting, diarrhoea, or rash). In Australian general practice, 89% of new AOM cases are managed with antibiotics. In Indonesia, similarly, our survey study demonstrated about 88% of physicians would prescribe antibiotics for children with mild AOM. Indonesian practice guidelines on the criteria for antibiotic use for AOM are vague.. Alternative treatments have been proposed for treating AOM, including herbal preparations, decongestants, and corticosteroids. However, the evidence for these are too weak to be recommended in clinical practice. The anti-inflammatory effect of corticosteroids suggests it could be a viable treatment alternative for AOM. Moreover, corticosteroids are effective additions to treatment for other, more serious acute respiratory infections, including pneumonia and bacterial meningitis. However, there is insufficient evidence of efficacy and harms for AOM: a systematic review of randomised controlled trials (RCTs) of corticosteroids for AOM (two small studies; very low to low quality) indicated it might be useful clinically, but the small sample size and wide confidence intervals around the observed results leave too much uncertainty. An additional RCT showed a reduction of the duration of ear discharge in children with AOM and ventilation tubes. Accordingly, we plan to conduct an adequately powered clinical trial to address the uncertainties around the effectiveness of corticosteroids for AOM in children. Initially, we need to conduct this pilot study with an associated mechanistic sub-study using tympanometry. The pilot study will test the feasibility of characteristics of our main study design and all the study procedures, as well as other operational strategies in our proposed main study. As one of our outcomes is to assess the ability to measure planned outcomes of the proposed main study, we will also obtain the outcomes and report these narratively. The mechanistic sub-study will explore the potential mechanism of action of corticosteroids in the resolution of middle ear effusion in AOM.
Eligibility
Inclusion Criteria1
- Children with acute otitis media, defined as a current onset within 48 to 72 hours of ear-related symptoms (e.g. ear pain, ear tugging/rubbing or irritability for non-verbal young children) and/or signs of acute inflammation (e.g. erythema ear drum) and middle ear effusion (e.g. bulding ear drum, air-fluid level, purulent appearance of ear drum) if feasible to assess using otoscope,
Exclusion Criteria9
- Children with major and severe medical conditions (e.g. heart failure, kidney failure)
- Immunocompromised children (e.g. HIV, children receiving cancer treatment)
- Children with congenital malformations and/or syndromes (e.g. cleft palate, Down’s syndrome)
- Children with high risk of risk of strongyloidiasis infection
- Children with ear ventilation tube(s)
- Children who had exposed to persons with varicella (chicken pox) or active Zoster infection in the past 3 weeks without any prior varicella immunisation or infection
- Children who have taken systemic (i.e. oral, injection) or topical steroids in the preceding four weeks
- Children who have taken antibiotics in the preceding two weeks
- Children who are hypersensitive to prednisolone or prednisone, or other corticosteroids.
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Interventions
Oral prednisolone (tablet): - The dose administered based on age range: once daily of 10 mg for children aged 6 months to < 2 years; 20 mg for children aged 2 years to < 6 years; and 30 mg for children aged 6 years to 12 years - The duration of administration: 5 (five) days - The mode of administration: oral tablet Prednisolone tablets will be crushed by the pharmacist, then will be mixed with sweeteners, and packed in a daily-dose paper-wrap. Children will be stratified based on disease severity to mild or severe acute otitis media (AOM). Children with mild symptoms and signs of AOM (e.g. mild ear pain fever less than 39 degree Celcius, mild bulging of ear drum) will be randomly allocated to intervention group (will receive oral prednisolone plus 48-hour expectant observation) or control group (48-hour expectant observation alone). Children with severe symptoms and signs of AOM (e.g. moderate to severe ear pain, fever 39 degree Celsius or more, moderate-to-severe bulging of the ear drum, AOM complications) will be randomly allocated to intervention group (will receive oral prednisolone plus antibiotics based on physicians' preferences) or control group (antibiotics alone). Parents or the caregivers will give the study medication to their children at home, once daily, in the morning (before 9 am) after breakfast, with a glass of water, milk, or juice, or mix the study medication powder with a small amount of soft food such as jam and yoghurt. to make the taste more palatable for children. Research team will send a daily text message to remind the parents/caregivers to give the study medicine daily for five days. We will also provide a symptom diary (consists of three mini booklets of diary that will record the symptoms at: (1) Day-1 to Day-3 (research team will collect the first booklet at Visit-1 or Day-3 after the randomisation/baseline visit); (2) Day-4 to Day-7 ( will be collected at Visit-2 or Day-7 after the randomisation); and (3) Day-8 to Day-14 (will be collected at Day-14 home visit. We included a mechanistic sub-study using tympanometry as a sub-study or part of the main study. As we did not determine the sample size for the pilot study, the mechanistic study will involve all children in the pilot study (n=60), All children will undergo tympanometry examination in each follow-up visit (Visit-0/Day-0; Visit-1/Day-3; Visit-2/Day-7; Visit-3/Day-30; Visit-4/Day-90), regardless to groups they are allocated to. At each visit, after a consultation and ENT examination conducted by a physician, the subject will undergo a tympanometry examination . The audiologists will identify the condition of ear canal (e.g. ear wax) and estimate the size of the ear cuffs. Then the audiologist will insert appropriate-size ear cuffs into the probe tip and ask for the assistance of an attending nurse or the parents to hold the subject's head. She/he then will slowly insert the probe tip into the ear canal, until the graph appears on the screen. After the graph indicates the sufficient results (e.g. no air leak, no block), then she/he will conduct a similar procedure in the other side of the ears and print the results of both ears. The audiologist will write a subject registration number and date of examination on the printed paper, make a copy of the printed paper, record the tympanometry results of both ears (i.e. tympanogram curve types. ear canal volumes, compliance/static acoustic admittance, middle ear pressure), and attach the copied result of tympanometry examination on the 'Outcomes form'. The physicians then will analyse and interpret the tympanometry results. This procedure may require 10 to 30 minutes, depends on the subject's cooperation and the condition of the ear canals.
Locations(1)
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ACTRN12618000049279