A randomized, double-blind, placebo-controlled noninferiority trial of amoxicillin for clinically diagnosed acute otitis media in children 6 months to 5 years of age

Saux, Nicole Le; Gaboury, Isabelle; Baird, Marian; Klassen, Terry P.; MacCormick, Johnna; Blanchard, Colline; Pitters, Carrol; Sampson, Margaret; Moher, David

doi:10.1503/cmaj.1040771

Cited by 96 publications

(58 citation statements)

References 36 publications

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“…This change is supported by evidence on the safety of observation or delayed prescribing in young children. 30,31,32,75,76,81 A mechanism must be in place to ensure follow-up and begin antibiotics if the child fails observation.…”

Section: Changes From Previous Aom Guidelinementioning

confidence: 99%

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The Diagnosis and Management of Acute Otitis Media

Tunkel

Rosenfeld²,

Sevilla³

et al. 2013

Pediatrics

1,062

832

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This evidence-based clinical practice guideline is a revision of the 2004 acute otitis media (AOM) guideline from the American Academy of Pediatrics (AAP) and American Academy of Family Physicians. It provides recommendations to primary care clinicians for the management of children from 6 months through 12 years of age with uncomplicated AOM.In 2009, the AAP convened a committee composed of primary care physicians and experts in the fields of pediatrics, family practice, otolaryngology, epidemiology, infectious disease, emergency medicine, and guideline methodology. The subcommittee partnered with the Agency for Healthcare Research and Quality and the Southern California Evidence-Based Practice Center to develop a comprehensive review of the new literature related to AOM since the initial evidence report of 2000. The resulting evidence report and other sources of data were used to formulate the practice guideline recommendations.The focus of this practice guideline is the appropriate diagnosis and initial treatment of a child presenting with AOM. The guideline provides a specific, stringent definition of AOM. It addresses pain management, initial observation versus antibiotic treatment, appropriate choices of antibiotic agents, and preventive measures. It also addresses recurrent AOM, which was not included in the 2004 guideline. Decisions were made on the basis of a systematic grading of the quality of evidence and benefit-harm relationships.The practice guideline underwent comprehensive peer review before formal approval by the AAP.This clinical practice guideline is not intended as a sole source of guidance in the management of children with AOM. Rather, it is intended to assist primary care clinicians by providing a framework for clinical decision-making. It is not intended to replace clinical judgment or establish a protocol for all children with this condition. These recommendations may not provide the only appropriate approach to the management of this problem. Pediatrics 2013;131:e964-e999

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Section: Changes From Previous Aom Guidelinementioning

confidence: 99%

“…Of the 10 eligible studies, the investigators of 6 studies 30,75,[86][87][88][89] provided the original data requested, and 4 did not. A total of 1642 patients were included in the 6 studies from which data were obtained.…”

Section: Importance Of Accurate Diagnosismentioning

confidence: 99%

The Diagnosis and Management of Acute Otitis Media

Tunkel

Rosenfeld²,

Sevilla³

et al. 2013

Pediatrics

1,062

832

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“…However, due to the many cases of acute otitis media that resolve spontaneously, as well as concerns about the excessive use of antibiotics, in many regions the recommendation is not to treat acute otitis media with antibiotics unless children present high fever or persistent signs and symptoms after being given analgesic for 48 to 72 hours. [32][33][34][35][36] In the Netherlands, only 31% of children with acute otitis media are given antibiotics, while in the USA and Australia this rate is over 95%. 33 A metanalysis of eight studies comprising 2,287 children with acute otitis media found that antibiotics were not superior to placebo in relieving symptoms within the first 24 hours of treatment, but reduced pain in 30% of cases after two to seven days.…”

Section: Acute Otitis Mediamentioning

confidence: 99%

“…33 As the clinical condition resolved spontaneously in 80% of untreated children, the estimated benefit of antibiotic use was only 7%; estimates showed that symptoms resolved in only one child out of 15 that were treated with antibiotics. 33 Symptoms of acute otitis media resolve in 61% of children after 24 hours, and in 80% after two to three days, 36 regardless of antibiotic treatment.…”

Section: Acute Otitis Mediamentioning

confidence: 99%

“…[32][33][34][35][36][37][38][39][40] In another study, children aged from 6 months to 12 years with mild or moderate acute otitis media were randomized for prompt antibiotic treatment (n=112) or antibiotics only if symptoms persisted (n = 111). Family members and caretakers accepted well this type of guidance, and on day 12, 69% of antibiotic-treated children had normal tympanic membranes compared to 51% in the control group.…”

Section: Acute Otitis Mediamentioning

confidence: 99%

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Otimizando o diagnóstico para o tratamento adequado das principais infecções agudas em otorrinopediatria: tonsilite, sinusite e otite média

Sih

Bricks

2008

Rev. Bras. Otorrinolaringol.

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As sinusites, otites médias agudas e tonsilites são muito freqüentes em crianças. A maioria dessas infecções é causada por vírus, mas em geral, elas são tratadas com antibióticos. O uso inapropriado de antibióticos favorece a seleção, crescimento e disseminação de bactérias resistentes que colonizam as vias respiratórias, atingindo toda a comunidade. A emergência de bactérias resistentes dificulta os tratamentos das infecções respiratórias, sendo essencial desenvolver estratégias efetivas para restringir o uso de antibióticos sem prejudicar as crianças que realmente precisam desses medicamentos. OBJETIVO: Analisar os resultados de estudos randomizados e controlados sobre critérios clínicos e laboratoriais utilizados para diagnóstico e tratamento das tonsilites, sinusites e otites. MÉTODOS: Levantamento dos estudos randomizados e controlados sobre o tema, publicados no MEDLINE e SCIELO, de 2000 a 2006. CONCLUSÕES: Como a maioria dessas infecções evolui bem sem antibióticos, deve-se evitar o uso desses medicamentos a menos que a criança pertença aos grupos de alto risco para complicações ou apresente persistência ou piora dos sintomas com tratamento sintomático. É necessário que os médicos e leigos conheçam melhor a evolução natural das infecções respiratórias agudas e que seja garantido o acesso das crianças a serviços médicos de boa qualidade para orientação e reavaliação, quando necessária.

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