Oral antibiotics confer small benefits and small harms in low-risk children with acute otitis media

Gunasekera, Hasantha

doi:10.1136/eb-2013-101341

Cited by 2 publications

(1 citation statement)

References 5 publications

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“…High-level evidence from studies in developed countries shows that immediate antibiotic treatment confers only a modestly decreased duration of pain and fever at the cost of increased side effects [ 12 – 17 ]. International treatment guidelines [ 18 , 19 ] currently recommend watchful waiting (initial observation and symptomatic treatment) and avoidance of immediate antibiotic treatment of AOM in children older than 2 years of age who are at low risk of complications.…”

Section: Introductionmentioning

confidence: 99%

A multi-centre open-label randomised non-inferiority trial comparing watchful waiting to antibiotic treatment for acute otitis media without perforation in low-risk urban Aboriginal and Torres Strait Islander children (the WATCH trial): study protocol for a randomised controlled trial

Abbott

Gunasekera

Leach

et al. 2016

Trials

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BackgroundTreatment guidelines recommend watchful waiting for children older than 2 years with acute otitis media (AOM) without perforation, unless they are at high risk of complications. The high prevalence of chronic suppurative otitis media (CSOM) in remote Aboriginal and Torres Strait Islander communities leads these children to be classified as high risk. Urban Aboriginal and Torres Strait Islander children are at lower risk of complications, but evidence to support the subsequent recommendation for watchful waiting in this population is lacking.Methods/DesignThis non-inferiority multi-centre randomised controlled trial will determine whether watchful waiting is non-inferior to immediate antibiotics for urban Aboriginal and Torres Strait Islander children with AOM without perforation. Children aged 2 − 16 years with AOM who are considered at low risk for complications will be recruited from six participating urban primary health care services across Australia. We will obtain informed consent from each participant or their guardian. The primary outcome is clinical resolution on day 7 (no pain, no fever of at least 38 °C, no bulging eardrum and no complications of AOM such as perforation or mastoiditis) as assessed by general practitioners or nurse practitioners. Participants and outcome assessors will not be blinded to treatment. With a sample size of 198 children in each arm, we have 80 % power to detect a non-inferiority margin of up to 10 % at a significance level of 5 %, assuming clinical improvement of at least 80 % in both groups. Allowing for a 20 % dropout rate, we aim to recruit 495 children.We will analyse both by intention-to-treat and per protocol. We will assess the cost- effectiveness of watchful waiting compared to immediate antibiotic prescription. We will also report on the implementation of the trial from the perspectives of parents/carers, health professionals and researchers.DiscussionThe trial will provide evidence for the safety and effectiveness of watchful waiting for the management of AOM in Aboriginal and Torres Strait Islander children living in urban settings who are considered to be at low risk of complications.Trial registrationThe trial is registered with Australia New Zealand Clinical Trials Registry (ACTRN12613001068752). Date of registration: 24 September 2013.

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Section: Introductionmentioning

confidence: 99%

A multi-centre open-label randomised non-inferiority trial comparing watchful waiting to antibiotic treatment for acute otitis media without perforation in low-risk urban Aboriginal and Torres Strait Islander children (the WATCH trial): study protocol for a randomised controlled trial

Abbott

Gunasekera

Leach

et al. 2016

Trials

Self Cite

View full text Add to dashboard Cite

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Parental views on otitis media: systematic review of qualitative studies

et al. 2016

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• Otitis media is a leading cause of conductive hearing loss in children. • Parental perception of the treatment burden of otitis media can potentially affect their confidence and ability to care for their child. What is New: • We identified five themes to reflect parental perspectives: diminishing competency, disrupting life schedules, social isolation, threatening normal development, taking ownership, valuing support, and cherishing health. • Parents may perceive caring for a child with otitis media as disempowering and disruptive and with reoccurrence doubt treatment efficacy and their parental competency and develop fears regarding their child's development.

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Oral antibiotics confer small benefits and small harms in low-risk children with acute otitis media

Cited by 2 publications

References 5 publications

A multi-centre open-label randomised non-inferiority trial comparing watchful waiting to antibiotic treatment for acute otitis media without perforation in low-risk urban Aboriginal and Torres Strait Islander children (the WATCH trial): study protocol for a randomised controlled trial

A multi-centre open-label randomised non-inferiority trial comparing watchful waiting to antibiotic treatment for acute otitis media without perforation in low-risk urban Aboriginal and Torres Strait Islander children (the WATCH trial): study protocol for a randomised controlled trial

Parental views on otitis media: systematic review of qualitative studies

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