Evid Based Nurs 10:45 doi:10.1136/ebn.10.2.45
  • Treatment

Review: children <2 years of age with bilateral acute otitis media and children with otorrhoea benefit most from antibiotics

 Q Which subgroups of children with acute otitis media benefit from treatment with antibiotics?


GraphicData sources:

Cochrane Library, PubMed, EMBASE/Excerpta Medica, and proceedings of international symposia.

GraphicStudy selection and assessment:

randomised controlled trials (RCTs) that compared antibiotics with placebo or no treatment in children 0–12 years of age with acute otitis media and assessed pain and fever. 6 RCTs (n = 1643, mean age 3.4 y [range 0–11], 50% boys) met the selection criteria, and the authors were willing to supply raw data. Quality assessment based on 4 criteria (randomisation procedure; allocation concealment; follow up; and blinding of patients, caregivers, and outcome assessors) showed that the methodological quality of the individual trials was generally high.


a composite outcome of an extended course of acute otitis media, comprising pain (yes or no on parent diary), fever (temperature ⩾38°C), or both at 3–7 days. Secondary outcomes were pain and fever, assessed separately, and adverse effects.


Overall, antibiotics reduced an extended course of acute otitis media, pain, and fever (table). Subgroups of children <2 years of age with bilateral acute otitis media and children with otorrhoea benefited most from antibiotics (table). The most common adverse effects were diarrhoea (4–21% v 2–14% in the antibiotic and control groups, respectively) and rash (1–8% v 2–6%).

Antibiotics v placebo or no treatment for acute otitis media (AOM) in children*


In children with acute otitis media, treatment with antibiotics reduces pain and fever at 3–7 days and is particularly beneficial in children <2 years of age with bilateral acute otitis media and children with otorrhoea.

A modified version of this abstract appears in Evidence-Based Medicine.


  1. Paula Renouf, RN, MS, NP
  1. University of Auckland, School of Nursing,
 Auckland, New Zealand

      Current US and UK guidelines recommend immediate antibiotic treatment for acute otitis media in children <6 months of age and in children <2 years, unless symptoms are mild.1 Both endorse an observational strategy for children >2 years of age, with certain provisos. Although these positions are supported by Rovers et al, the conclusion of this thorough meta-analysis of 6 RCTs is that an observational policy also seems justified for children <2 years of age who do not have signs of bilateral disease or otorrhoea with acute otitis media.

      There are, however, caveats in making such recommendations based on meta-analyses in which significant clinical heterogeneity exists and more severely affected children are under-represented.2 Of the 6 RCTs, 2 excluded children deemed to need immediate antibiotics, 1 did not include children <2 years of age, and another included only non-severe cases. Only 42% of all study patients had a bulging tympanic membrane. Furthermore, 2 of the trials used very low dose antibiotic regimens. All of these factors could significantly bias results in favour of non-treatment despite rigorous statistical analysis.

      A nurse practitioner’s or prescriber’s decision to withhold or delay antibiotic treatment depends on confidence and skill in the diagnosis of bacterial acute otitis media, the parent-clinician relationship, and assessment of the individual child and age, host, and environmental risk factors. The value of this review is its contribution to knowledge about which children benefit most from antibiotics. Whereas most children presenting to primary care with otitis symptoms can be safely managed with a “watch and wait” approach, the absence of bilateral disease in children <2 years of age or otorrhoea at the time of presentation may not be enough to exclude all serious bacterial cases meriting immediate treatment.



      • For correspondence: Dr M M Rovers, Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands. M.Rovers{at}

      • Sources of funding: Dutch College of General Practitioners and the Netherlands Organisation for Health Research and Development.

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