Systemic corticosteroids for acute otitis media in children

Ranakusuma, Respati W.; Pitoyo, Yupitri; Safitri, Eka Dian; Thorning, Sarah; Beller, Elaine; Sastroasmoro, Sudigdo; Mar, Chris Del

doi:10.1002/14651858.cd012289.pub2

Cited by 6 publications

(2 citation statements)

References 48 publications

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“…However, their use should be considered in severe or complicated cases. Some authors suggest that the combined use of steroids and antibiotics improve the resolution of middle ear exudates when compared with antibiotics alone [23]. A systematic review by Ranakusuma et al evidenced an overall improvement in symptoms and a faster resolution of the middle ear inflammation in children treated with systemic steroids [24].…”

Section: Discussionmentioning

confidence: 99%

Acute Otitis Media and Facial Paralysis in Children: A Systemic Review and Proposal of an Operative Algorithm

Fichera,

Bruschini,

Berrettini

et al. 2023

Audiology Research

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Acute otitis media (AOM) is one of the most common ENT diseases in children. In the antibiotic/post-antibiotic era, facial paralysis is a very rare complication of AOM (0.004–0.005%). Despite the rarity of this complication, it should be known by all physicians for proper therapeutic management to avoid serious sequelae. The aim of this review is to provide a management guide based on the current literature. Materials and Methods: Fifteen studies published between 2000 and 2022 were selected, including 120 patients (62 M/58 F) with an average age of 4.96 years old (range = 4 months–16 years; SD: 4.2). The paralysis frequently has a sudden onset and is of a severe grade (medium House–Brackmann (HB) score at onset: 4.68; SD: 0.5); however, it tends to have an almost complete recovery in most patients (88.49% HB 1 at follow-up). Results: Its first-line treatment must be based on the use of antibiotics (beta-lactam antibiotics as penicillins or cephalosporins). Corticosteroids should be used concomitantly for their anti-inflammatory and neuroprotective actions; however, there is no unanimity between authors about their application. Myringotomy, with or without ventilation tube insertion, is indicated in cases where the tympanic membrane is intact. Other kinds of surgery should be performed only in patients who have a worsening of their AOM symptoms or a worsening in HB score even with clinical treatment. Conclusions: The obtained data show that a conservative treatment can be sufficient for complete recovery in most patients, and it is preferred as the first-line therapy. Mastoidectomy should be performed only in patients with acute mastoiditis and without symptom improvement after a conservative approach. There are insufficient data in the current literature to provide clear selection criteria for patients who need to undergo mastoidectomy with facial nerve decompression. The choice of this treatment is based on an individual center expertise. Further studies are needed to clarify the role of corticosteroids and the role of facial nerve decompression in this clinical scenario.

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Section: Discussionmentioning

confidence: 99%

Acute Otitis Media and Facial Paralysis in Children: A Systemic Review and Proposal of an Operative Algorithm

Fichera,

Bruschini,

Berrettini

et al. 2023

Audiology Research

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“…However, there is insufficient evidence of efficacy and harms for AOM. A Cochrane 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 [ 20 ]. An additional RCT of corticosteroids showed a reduction of the duration of ear discharge in children with AOM and ventilation tubes [ 21 ].…”

Section: Introductionmentioning

confidence: 99%

Oral prednisolone for acute otitis media in children: protocol of a pilot randomised, open-label, controlled study (OPAL study)

Ranakusuma

McCullough

Safitri

et al. 2018

Pilot Feasibility Stud

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BackgroundAcute otitis media (AOM) is an acute inflammation of the middle ear commonly found in children, for which antibiotics are frequently prescribed. However, antibiotics are beneficial for only one third of AOM cases, and then, with only modest benefit. Since antibiotic use leads to risk of side effects and resistance, effective alternative treatments are required. Corticosteroids are a candidate because of their anti-inflammatory effects, although evidence of their efficacy and harms is insufficient. Accordingly, we plan a large, rigorous clinical trial to test this. Initially, we will test pre-specified methods and procedures (including the overall process, resources, management, and scientific components) in a pilot study of corticosteroids for AOM, which will inform a future, definitive trial.MethodsThis is a pilot pragmatic, randomised, open-label, single-blind, controlled study of corticosteroids as either monotherapy or an addition to antibiotics in 60 children aged 6 months to 12 years with AOM in two cities (Jakarta and Bekasi) in Indonesia. We will randomise eligible children to prednisolone or control. We will also stratify by disease severity and randomise those with mild AOM to expectant observation plus prednisolone or observation alone and those with severe AOM to prednisolone plus antibiotic or antibiotic alone. Our outcomes are to determine (1) recruitment rates, (2) the success of the study procedures, (3) the ability to measure planned outcomes of the proposed main study, (4) the compliance to study visits and study medication, and (5) verification of the sample size calculation for the main study. We will also assess middle ear effusion using tympanometry as part of a mechanistic sub-study.DiscussionThis study will test all procedures in preparation for the main study, including several potential obstacles and challenges from the perspective of participating physicians, nurses, pharmacists, and the parents of eligible children. This information will be useful for developing strategies to overcome practical and procedural issues. This study may also provide information about the effects of corticosteroids on middle ear effusion in AOM.Trial registrationStudy registry number: ACTRN12618000049279. Name of registry: the Australian New Zealand Clinical Trials Registry (ANZCTR). Date of registration: 16 January 2018.Electronic supplementary materialThe online version of this article (10.1186/s40814-018-0337-x) contains supplementary material, which is available to authorized users.

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