SIGN’s otitis media guideline will help GPs to make a diagnosis and choose the right treatment approach to this common condition, says Professor John Bain

Middle ear infections are among the most common upper respiratory tract conditions in children seen in general practice. Some 75% of cases of acute otitis media occur in children under 10 years of age, while one in four children will have an episode of acute otitis media at some time before the age of 10 years with peak incidence occurring between 3 and 6 years of age.1

The prevalence of otitis media with effusion, or ‘glue ear’, is around 3% in children aged 6-8 years and this condition has important implications for child development.


Acute otitis media (AOM) is characterised by earache accompanied by redness of the eardrum, with or without aural discharge. The term otitis media with effusion (OME), refers to the presence of sterile fluid in the middle ear. In children, the fluid is usually thick and sticky in consistency and the individual child is often asymptomatic, with deafness frequently being the first sign of disease.

The diagnosis of otitis media is usually a presumptive one in general practice because a precise diagnosis can only be based on examination and microbiology of the middle ear effusion. Aspiration of middle ear fluid is not carried out in general practice in the UK, and it would be a mistake to make hard and fast classifications. In general practice it is useful to distinguish between acute otitis media and otitis media with effusion before deciding on treatment.

Figure 1 (below) gives the key to evidence statements and grades of recommendations for the evidence considered by the guideline development group.

Figure 1: Key to evidence statements and grades of recommendations

Medical treatment of AOM


The use of antibiotics in the treatment of AOM varies widely among countries, from 31% of cases in the Netherlands to over 98% in Australia and the United States.2

A meta-analysis showed that antibiotics do not affect resolution of pain within 24 hours of presentation. However, 2-7 days after presentation, when 14% of children in control groups continued to experience pain, early use of antibiotics reduced the risk of pain by approximately 40%.3 Antibiotics also reduced contralateral AOM but appear to have had little effect on subsequent attacks of otitis media or deafness. Antibiotic treatment was associated with almost twice the risk of vomiting, diarrhoea or rashes.3

A study of predictors of poor outcome found that in children with AOM but without fever and vomiting, antibiotic treatment had little benefit.4 The guideline states that the simplest way to target the few children at higher risk of a poor outcome would be to prescribe antibiotics only for those with systemic features (high temperature or vomiting). Antibiotic treatment may benefit infants and younger children with severe AOM.5

Around 17 children with AOM would need to be treated with an antibiotic to prevent one child having pain after two days.6

In children over 2 years of age, antibiotics may have a modest beneficial effect on symptom resolution and failure rates when compared with placebo and observational treatment; however, automatically resorting to antibiotics in all cases of AOM is not justified.

The evidence on the natural history of AOM shows that few children with AOM who are not initially treated with antibiotics experience episodes of mastoiditis or other suppurative complications.

Given the difficulty of applying the results of trials to day-to-day practice, particularly when there are doubts over how representative the subjects in clinical trials are, an alternative approach is worth considering.

In an open randomised controlled trial, 315 children aged 6 months to 10 years were assigned to two treatment strategies: immediate antibiotic; and delayed antibiotic, the antibiotic prescription to be collected at the parents’ discretion after 72 hours if the child was not improving.7

The outcome measures were: symptom resolution; absence from nursery or school; and paracetamol consumption. The main conclusions were that:

  • Antibiotics given immediately provided symptomatic benefit mainly after the first 24 hours, when symptoms were already resolving.
  • Antibiotics given immediately increased diarrhoea incidence by 10%.
  • Only 24% of the parents in the delayed prescription group returned for antibiotics.
  • There was no significant difference in outcomes between the two groups in terms of symptom resolution or absence from nursery or school.
  • A ‘wait and see’ approach is feasible and acceptable to most parents, and reduces the use of antibiotics by 76%.

Decongestants, antihistamines and mucolytics

A Cochrane Review of decongestant antihistamine mixtures found no benefit in terms of early or late cure rates, symptom resolution or complications. There was an increased risk of side-effects for those receiving medication. No evidence to support the use of mucolytics for AOM was found.8


There is very limited information in the literature about the use of analgesics. The guideline advises that parents should give paracetamol at recommended doses and that they should be informed of the potential danger of overuse.

The key recommendations for treatment of AOM are summarised in Box 1 (below).

Box 1: Treatment of acute otitis media
  • Children should not routinely be prescribed antibiotics as the initial treatment
  • Delayed antibiotic treatment (antibiotic to be collected at parent’s discretion after 72 hours if the child has not improved) is an alternative approach which can be applied in general practice
  • If an antibiotic is to be prescribed, the conventional 5-day course is recommended at dosage levels indicated in the British National Formulary
  • Children should not be prescribed decongestants or antihistamines
  • Paracetamol should be given for analgesia, but overuse should be discouraged

Medical treatment of OME


The literature on the role of antibiotics in the management of OME is extensive, but there are relatively few randomised controlled trials.

In general, the better conducted trials suggest a short-term benefit from antibiotics but this appears to be short-lived (2-4 weeks). The short-term benefits that appear to be scientifically demonstrable are not sufficient reason to recommend antibiotics in OME.

Decongestants, antihistamines and mucolytics

One systematic review considered four RCTs which studied decongestants and antihistamines, but reported on a heterogeneous patient group.9 It found no convincing evidence of benefit from these drugs on the clearance rate of middle ear effusion. Similarly, no evidence was found to support the routine use of mucolytics in treating OME.


Four comparisons of the use of steroids were investigated:

  • Oral steroids versus control
  • Oral steroids plus antibiotics versus control plus antibiotic
  • Intranasal steroids versus control
  • Intranasal steroids plus antibiotic versus control plus antibiotic or antibiotic alone.

Although some improvements were reported, all the reviews concluded that they could not recommend the use of steroids in OME.9-11


One systematic review considered six randomised controlled trials, and despite conflicting evidence there appeared to be some clinical benefit.12 However, young children may find autoinflation devices difficult to use and trials suggest that a high level of compliance results in most benefit.

The key recommendations for the medical treatment of OME are shown in Box 2 (below).

Box 2: Medical management of OME  
Recommendation Grade
  • Children with OME should not be treated with antibiotics
  • Decongestants, antihistamines and mucolytics should not be used in the management of OME
  • Topical or systemic steroid therapy is not recommended in the management of OME
  • Autoinflation may be of benefit in the management of some children with OME

Follow up

Follow up for AOM

Most cases of AOM resolve spontaneously. However, it is difficult to visualise the tympanic membrane of a discharging ear, so patients should be re-examined after 2 weeks; those with persisting problems should be referred to an otolaryngologist.

Follow up for OME

Children with OME should be observed for a time to evaluate severity and disability and the need for referral. Otoscopy, and if facilities are available, audioscopy and tympanometry, may be needed. Two or three visits at monthly intervals may be required to establish the need for referral. In making this decision, progress reported by parents and teachers is often invaluable.


Acute otitis media

No studies were found concerning when patients with AOM should be referred. NICE recommends that patients with frequent episodes of AOM, defined as more than four episodes in 6 months should be referred.

As there is no evidence better than expert opinion available, the NICE recommendation has been adopted.13

Otitis media with effusion

The development group found no studies on the referral of OME patients; however, evidence from three trials that compared early grommet insertion with delayed surgery/watchful waiting may be helpful. For children under 3 years of age with OME and mild to moderate hearing loss (<25dB, defined by audiometry) but no other problems, watchful waiting has been shown to be as effective as early surgery.14

One trial that showed benefits from early surgery included children over 3 years of age and those with behavioural or language problems. The guideline therefore recommends that children with persistent OME over 3 years of age, or with language, behavioural or developmental problems should be referred.

The recommendations for follow up and referral are summarised in Box 3 (below).

Box 3: Referral  
Acute otitis media
  • Children with frequent episodes (more than four in 6 months) of AOM, or complications should be referred to an otolaryngologist
Otitis media with effusion
  • Children under 3 years with persistent bilateral OME and hearing loss of <=25 dB, but no speech and language, developmental or behavioural problems, can be safely managed with watchful waiting
  • If watchful waiting is being considered, the child should undergo audiometry to exclude a more serious degree of hearing loss
  • Children with persistent bilateral OME who are over 3 years of age or who have speech and language, developmental or behavioural problems should be referred to an otolaryngologist

Patient issues

AOM and OME are particularly common in preschool children, and parents, teachers and carers should be aware of this. Most cases are transient episodes, but they can recur and may vary in presentation.

Primary care professionals should ensure that carers have clear information about what to look out for. Box 4 (below) outlines the key points for parents and carers.

Box 4: Advice for parents  
Recommendation Grade
  • Parents of children with otitis media with effusion should be advised to refrain from smoking
  • Parents should be advised that breastfeeding may reduce the risk of their child developing OME
  • Grommet insertion is not a contraindication to swimming
  • In children with grommets it is advisable to avoid immersing the head in soapy water

Figures 2 and 3 (below) show the guideline’s quick reference guide.

Figure 2: Front of the quick reference guide
Figure 3: Reverse of the quick reference guide


Acute otitis media and otitis media with effusion are problems that present frequently in general practice. While it has been conventional wisdom to prescribe antibiotics for children with presumed acute otitis media, GPs should be aware that in children aged 2 years and over with mild to moderate symptoms and signs, a ‘wait and see’ policy is perfectly justified. There is always the option of adopting the delayed treatment strategy, which allows parents to return if the child’s condition is not improving.

Many children with AOM are now seen by out-of-hours services. As follow up by the child’s own GP is unlikely to be delayed by more than a few hours, analgesia plus the ‘wait and see’ approach, rather than automatic recourse to antibiotic treatment, is reasonable in most cases.

In cases of otitis media with effusion, careful follow up of hearing is important. Parents and teachers can often recognise when the child’s hearing is deteriorating.

Few GPs have the facilities and skills to measure hearing, and it is important that they have access to audiology services where audiometry and tympanometry can be carried out in a suitable environment by skilled staff.

The guideline focuses on practical day-to-day issues in general practice and can be used as a basis for practice policies for the management of this common condition in general practice.

SIGN guideline No 66: Diagnosis and management of childhood otitis media in primary care is available on the SIGN website:, and can be downloaded free of charge.


  1. Hart C, Bain J (eds). Child Care in General Practice. London: Churchill Livingstone, 1989.
  2. Froom J, Culpepper L, Grob P et al. Diagnosis and antibiotic treatment of acute otitis media: report from International Primary Care Network. Br Med J 1990; 300: 582-6.
  3. Del Mar C, Glasziou P, Hayem M. Are antibiotics indicated as initial treatment for children with acute otitis media? A meta-analysis. Br Med J 1997; 317: 1526-9.
  4. Little P, Gould C, Moore M et al. Predictors of poor outcome and benefits from antibiotics in children with acute otitis media: pragmatic randomised trial. Br Med J 2002; 325: 22.
  5. Kaleida PH, Casselbrant ML, Rockette HE et al. Amoxicillin or myringotomy or both for acute otitis media: results of a randomized clinical trial. Pediatrics 1991; 87: 466-74.
  6. Glasziou PP, Del Mar CB, Sanders SL, Hayem M. Antibiotics for acute otitis media in children (Cochrane Review). In: The Cochrane Library, Issue 2, 2002. Oxford: Update Software.
  7. Little P, Gould C, Williamson J et al. Pragmatic randomised controlled trial of two prescribing strategies for childhood acute otitis media. Br Med J 2001; 322: 336-42.
  8. Flynn CA, Griffin G, Tudiver F. Decongestants and antihistamines for acute otitis media in children (Cochrane Review). In: The Cochrane Library, Issue 2, 2002. Oxford: Update Software.
  9. US Department of Health and Human Services. Agency for Health Care Policy and Research. Otitis media with effusion in young children. Rockville (MD): The Agency; 1994. Clinical Practice Guideline No. 12. AHCPR Publication No. 94-0622.
  10. Butler CC, van der Voort JH. Oral or topical nasal steroids for hearing loss associated with otitis media with effusion in children (Cochrane Review). In: The Cochrane Library, Issue 2, 2002. Oxford: Update Software.
  11. Nuss R, Berman S. Medical management of persistent middle ear effusion. Am J Asthma Allergy Pediatricians 1990; 4: 17-22.
  12. Reidpath DD, Glasziou PP, Del Mar C. Systematic review of autoinflation for treatment of glue ear in children. Br Med J 1999; 318: 1177.
  13. National Institute for Clinical Excellence. Referral Advice: A guide to appropriate referral from general to specialist services. London: NICE, 2001.
  14. Paradise JL, Feldman HM, Campbell TF et al. Effect of early or delayed insertion of tympanostomy tubes for persistent otitis media on developmental outcomes at the age of three years. N Engl J Med 2000; 344: 1179-87.

Guidelines in Practice, May 2003, Volume 6(5)
© 2003 MGP Ltd
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