Dr Caroline Ward examines updated NICE guidance on the management of acute otitis media, which aims to limit inappropriate prescribing of antibiotics
Read this article to learn more about:
- use of eardrops containing an anaesthetic and an analgesic in children and young people with acute otitis media (AOM)
- the role of antibiotics in the treatment of AOM, and strategies to prevent inappropriate antibiotic use
- providing advice on the best-practice management of AOM to patients and parents.
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Acute otitis media (AOM) is usually a self-limiting infection that, in most children, resolves in around 3 days without treatment.1 It is defined as the presence of inflammation in the middle ear, associated with effusion and the rapid onset of signs and symptoms of an ear infection.2,3 There are no gold-standard criteria for the diagnosis of AOM; however, the presence of a cloudy, bulging tympanic membrane that shows impaired mobility is the best predictor of AOM.2 Figure 1 shows a bulging tympanic membrane in a paediatric patient with AOM.4
AOM occurs most often in children aged 4 years or younger.5 Children are more likely than adults to develop AOM because they have higher rates of viral infections, and shorter and more horizontal Eustachian tubes.6
AOM can be caused by both viruses and bacteria, and commonly both are present at the same time.1 The most common bacterial pathogens are Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and S. pyogenes.1 Viral pathogens associated with AOM include respiratory syncytial virus, rhinovirus, adenovirus, coronavirus, bocavirus, influenza virus, parainfluenza virus, enterovirus, and human metapneumovirus.7
In 2012, AOM accounted for over half a million primary care consultations in the UK, most of which took place in the winter months.8
Diagnosis of AOM
A diagnosis of AOM is appropriate if there is acute onset of symptoms, including:9
- in older children and adults—earache
- in younger children—holding, tugging, or rubbing of the ear, or nonspecific symptoms such as fever, crying, poor feeding, restlessness, behavioural changes, cough, or rhinorrhoea.
On otoscopic examination, the following findings support a diagnosis of AOM:9
- a red, yellow, or cloudy tympanic membrane
- moderate to severe bulging of the tympanic membrane, with loss of normal landmarks and an air–fluid level behind the tympanic membrane (indicates middle-ear effusion)
- perforation of the tympanic membrane and/or discharge in the external auditory canal.
Diagnosis can be difficult in children younger than 6 months of age, and particularly in those less than 3 months old, because:9
- there may be coexisting systemic illness, such as bronchiolitis or bacteraemia
- symptoms are likely to be nonspecific
- the tympanic membrane may not be visible—it often lies in an oblique position, and the ear canal is small and tends to collapse.
Otitis media with effusion
Clinicians should be careful not to confuse AOM with otitis media with effusion (OME; also known as ‘glue ear’), which presents with fluid in the middle ear but without the signs and symptoms of an acute ear infection.10 Figure 2 shows the typical appearance of the tympanic membrane in a paediatric patient with OME.4
The need for an updated guideline
NICE Guideline (NG) 91, Otitis media (acute): antimicrobial prescribing, was first published in 2018 and was updated in March 2022 to include a new recommendation on eardrops containing an anaesthetic and an analgesic.1 This is because a licensed preparation of eardrops containing an anaesthetic and an analgesic is now available in the UK.11
The updated recommendations of NG91 provide a range of options that aim to limit antibiotic use, thereby reducing the likelihood of development of antimicrobial resistance,1 and will be covered in the following sections.
Nonantimicrobial treatments for AOM
Because AOM is a self-limiting illness in most children, analgesia is the mainstay of treatment.1 Children should be offered regular doses of paracetamol or ibuprofen for pain.1 It is important to use the right dose for the age or weight of the child at the right time, and to use maximum doses for severe pain.1 Please see the British National Formulary for Children for further details on dosing.12,13
Topical anaesthetic–analgesic eardrops
Phenazone with lidocaine eardrops have recently been licensed in the UK for use in AOM.1,11 These can be prescribed for use in addition to oral analgesia for pain management if there is no eardrum perforation or otorrhoea (discharge following eardrum perforation). Side effects are rare, with the main undesirable effects being skin reactions and auditory canal and tympanic membrane hyperaemia.11,14
A UK clinical trial conducted in 2019 suggested that the prescribing of eardrops containing an anaesthetic and an analgesic in children with AOM significantly reduced antibiotic use.15 There was also a statistically significant reduction in parent-reported pain scores.15 No adverse effects were reported with eardrop use, but this was based on very small numbers of children.1,15 Previous studies have shown that similar eardrops significantly reduced pain scores in children aged 3 years and older compared with placebo.16
There is no direct evidence to support the use of eardrops containing an anaesthetic and an analgesic in children who need immediate antibiotics. Therefore, NICE recommends these eardrops only for children who do not need an immediate oral antibiotic.1
Evidence shows that neither decongestants nor antihistamines help with symptoms of AOM.1
Use of antibiotics for AOM
AOM is usually self-limiting and, in most children, it resolves without antibiotics.1 Therefore, most children with AOM should not be offered an immediate antibiotic.1 In most cases, recommended management would be either with no antibiotic, or with a back-up (delayed) antibiotic prescription.1
Treatment with an antibiotic is likely to be more beneficial in the following groups:1
- children under 2 years of age with bilateral AOM
- children of any age with AOM and otorrhoea
- children of any age who are systemically very unwell, have symptoms and signs of a more serious illness or condition, or are at high risk of complications.
For children aged under 2 years with infection in both ears and for children of any age with otorrhoea, NICE recommends that a no-antibiotic or back-up antibiotic strategy could also be appropriate, based on clinical judgement and discussion with the parent and/or patient.1
NICE does not routinely recommend immediate antibiotics for children aged 2 or over without otorrhoea.1
Resource implications of antibiotic prescribing for AOM
In my experience, respiratory tract infections and AOM are a common reason for consultations in primary care, and a common reason for potential antibiotic prescribing.1 Parents or carers of children with AOM may not know that they are likely to get better without treatment, and may expect an antibiotic prescription. Their expectations should be managed by explaining the harms of unnecessary antibiotics, for both the patient and the population. Self-management advice should also be given.1,17
Back-up antibiotic prescribing for respiratory conditions is known to lead to a significant reduction in antibiotic use compared with immediate antibiotic prescribing.18 In 2017, a Cochrane systematic review found that delayed antibiotics achieved lower rates of antibiotic use compared with immediate antibiotics (31% versus 93%; moderate-quality evidence).18
The place of antibiotics in managing complications of AOM
Common complications of AOM include recurrent infection, short-term hearing loss, and perforated eardrum.19 However, antibiotic use makes little difference to the development of these complications.1,20
More serious complications of AOM, such as mastoiditis, meningitis, intracranial abscess, sinus thrombosis, and facial nerve paralysis, are rare.1,19 The risk of mastoiditis after AOM is 3.8 per 10,000 episodes without antibiotics, which is reduced to 1.8 per 10,000 episodes with antibiotics.21 This gives a number needed to treat of 4831 to prevent one child from developing mastoiditis.21
The role of antibiotics in managing pain in AOM
Antibiotics do not significantly reduce pain at 24 hours compared with placebo in children with AOM.20 After 24 hours, around 60% of children are pain-free with or without antibiotics.20 Antibiotics do reduce pain at 2–3 days, but the absolute difference is small: 88% pain free with antibiotics versus 84% pain free without.1,20
Judicious use of antibiotics
Immediate antibiotics are of limited clinical benefit in most children, but are associated with a significantly increased risk of adverse events, such as vomiting, diarrhoea, or rash.20 A back-up antibiotic prescription or no antibiotic prescription should be considered for most children with AOM.1
When no antibiotic is prescribed, advise patients and parents or carers that:1
- an antibiotic is not needed because it is likely to make little difference to symptoms and may cause adverse events—for example, diarrhoea and nausea
- they should seek medical help if symptoms worsen rapidly or significantly or do not start to improve after 3 days, or if the child or young person becomes systemically very unwell.
Back-up antibiotic strategy
A back-up prescription is a prescription given to a patient, parent, or carer, which is not to be started immediately but in a few days if symptoms worsen (it can be post-dated). This strategy can be useful when there is clinical uncertainty about whether a condition is self-limiting or is likely to deteriorate.17 Back-up prescribing encourages self-management as a first step,17 but allows a person to access antimicrobials without another appointment if their condition gets worse or does not improve as expected.
When a back-up prescription is given, patients and parents or carers should be advised:1
- that an antibiotic is not needed immediately because it is likely to make little difference to symptoms and may cause adverse events
- to use the back-up prescription if symptoms do not start to improve in 3 days, or if they worsen rapidly or significantly at any time
- to seek medical help if symptoms worsen rapidly or significantly, or the child or young person becomes systemically very unwell.
Immediate antibiotics should be offered to children who are systemically very unwell, have symptoms or signs of a more serious illness, or are at high risk of serious complications because of pre-existing comorbidity.1 This includes children with significant heart, lung, renal, liver, or neuromuscular disease, immunosuppression, and cystic fibrosis, and young children who were born prematurely.1
An immediate antibiotic should be considered in children aged under 2 years with bilateral AOM, or in children of any age with otorrhoea.1 However, a no-antibiotic or back-up antibiotic strategy may also be appropriate in these children, depending on clinical judgement.1
When prescribing an antibiotic, advise patients and parents or carers to seek medical help if symptoms do not start to improve within 3 days or if they worsen rapidly or significantly at any time, or if the child or young person becomes systemically very unwell.1
A summary of management options for AOM is shown in Table 1.1
|AOM and:||Management options|
|Oral analgesia||No antibiotic||Back-up antibiotic||Immediate antibiotic||Anaesthetic–analgesic eardrops[A]|
|age <2 years with bilateral infection||✓||✓||✓||✓||✓|
|age <2 years with unilateral infection||✓||✓||✓||✗||✓|
|age ≥2 years with uni- or bilateral infection||✓||✓||✓||✗||✓|
|any age with otorrhoea or perforated tympanic membrane||✓||✓||✓||✓||✗|
|[A] Ensure that there is no tympanic membrane perforation or otorrhoea. Only recommended when not prescribing antibiotics for immediate use.
[B] Also consider the need for admission in these children.
|AOM=acute otitis media|
Table 2 outlines treatment choice, dosage, and course length for AOM.1,12–14,22
|Self-care (OTC)||Paracetamol||Use the right dose for the age or weight of the child, and use maximum doses for severe pain12,13|
Eardrops containing an anaesthetic and an analgesic[A]
Phenazone 40 mg/g with lidocaine 10 mg/g14
Apply four drops two to three times a day for up to 7 days
Oral antibiotic (all for 5–7 days)
1–11 months: 125 mg TDS
1–4 years: 250 mg TDS
5–17 years: 500 mg TDS
Penicillin allergy or intolerance (for people who are not pregnant)
1 month to 11 years:
Under 8 kg: 7.5 mg/kg BD
8–11 kg: 62.5 mg BD
12–19 kg: 125 mg BD
20–29 kg: 187.5 mg BD
30–40 kg: 250 mg BD
Penicillin allergy in pregnancy
Second choice (worsening symptoms on first choice taken for at least 2–3 days)
1–11 months: 0.25 ml/kg of 125/31 suspension TDS
1–5 years: 5 ml of 125/31 suspension TDS or 0.25 ml/kg of 125/31 suspension TDS
6–11 years: 5 ml of 250/62 suspension TDS or 0.15 ml/kg of 250/62 suspension TDS
12–17 years: 250/125 mg or 500/125 mg TDS
(see the BNFC for details of weight-related dosing)22
Alternative second choice for penicillin allergy or intolerance
Consult local microbiologist
[A] Use only if an immediate oral antibiotic prescription is not given, and there is no eardrum perforation or otorrhoea.
See the BNFC for appropriate use and dosing in specific populations—for example, hepatic impairment and renal impairment.
AOM=acute otitis media; OTC=over the counter; POM=prescription-only medicine; TDS=three times daily; BD=twice daily; QDS=four times daily; BNFC =British National Formulary for Children
Information for patients and parents
NICE has produced a patient information leaflet about AOM (bit.ly/3whbyFH).23 It contains information on the management of the condition, and includes a decision aid to be used with or by parents to help them understand the role of antibiotics in the treatment of AOM.23 It is available online, and can be downloaded as a PDF, easily printed, or sent as a link via email or messaging software to patients and parents or carers.
Referral to hospital
Some children with AOM may be very unwell or develop serious complications. They should be referred to hospital for immediate assessment if they have:1
- a severe systemic infection
- suspected acute complications of AOM, such as meningitis, mastoiditis, intracranial abscess, sinus thrombosis, or facial nerve paralysis.
Children less than 3 months of age with a temperature of 38°C or more should be considered as being at high risk for serious illness, and those aged between 3 and 6 months with a temperature of 39°C or more should be considered as being at least at intermediate risk. Refer to NG143, Fever in under 5s: assessment and initial management,24 for more information.24
AOM is most commonly a viral, self-limiting condition. The mainstay of treatment for the majority of children should be regular oral analgesia, plus consideration of topical anaesthetic and analgesic eardrops if the tympanic membrane is intact. Immediate antibiotics should normally be reserved for those who are systemically unwell or at high risk of complications. Antibiotics are of little clinical benefit in most children, and can lead to side effects such as diarrhoea. Back-up antibiotic prescribing can be a useful alternative to immediate antibiotics, and is an effective antimicrobial stewardship strategy to reduce unnecessary antibiotic consumption.
- AOM is usually a self-limiting infection that resolves in most children in around 3 days
- Most children with AOM should not be offered an immediate antibiotic, as it will make little difference to symptoms
- Antibiotics also do little to prevent complications of AOM such as perforated eardrum, recurrent infection, or short-term hearing loss
- Serious complications, such as mastoiditis, are rare with or without antibiotics
- Children more likely to benefit from antibiotics include those of any age with otorrhoea, and those aged under 2 years with bilateral AOM; however, a no-antibiotic or back-up antibiotic strategy may also be appropriate
- Children who are systemically very unwell, have symptoms and signs of a more serious illness, or are at high risk of complications should be offered an immediate antibiotic
- Advise patients and parents or carers to use regular doses of paracetamol or ibuprofen for pain
- Consider prescribing eardrops containing an anaesthetic and an analgesic for pain if an immediate antibiotic is not given and there is no eardrum perforation or otorrhoea
- Consider the use of patient information to help patients and parents understand the limited role of antibiotics in AOM.
AOM=acute otitis media
Implementation actions for STPs and ICSs
written by Dr David Jenner, GP, Cullompton, Devon
The following implementation actions are designed to support STPs and ICSs with the challenges involved in implementing new guidance at a system level. Our aim is to help you to consider how to deliver improvements to healthcare within the available resources.
- Update local formularies and online guidance on the management of otitis media based on NG91
- Ensure that this guidance is shared with all first-contact primary care services, including community pharmacy and out-of-hours services
- Consider publishing guidance leaflets for parents to help support a no-antibiotic or back-up antibiotic approach, where appropriate
- Target support and education to primary care services that appear to have high antibiotic prescription rates.
STP=sustainability and transformation partnership; ICS=integrated care system; NG=NICE Guideline
Dr Caroline Ward
GP and standing member of the NICE Managing Common Infections Advisory Committee
The guideline referred to in this article was produced by the National Guideline Centre for NICE.
The views expressed in this article are those of the author and not necessarily those of NICE.
NICE. Otitis media (acute): antimicrobial prescribing. NICE, 2022. Available at: www.nice.org.uk/ng91
- NICE. Otitis media (acute): antimicrobial prescribing. NICE Guideline 91. NICE, 2018 (last updated March 2022). Available at: www.nice.org.uk/ng91
- Lieberthal A, Carroll A, Chonmaitree T et al. The diagnosis and management of acute otitis media. Pediatrics 2013; 131 (3): e964–e999.
- NICE. Otitis media—acute: what is it? NICE Clinical Knowledge Summary. cks.nice.org.uk/topics/otitis-media-acute/background-information/definition/ (accessed 16 May 2022).
- Nguyen J, Das P, Bevan C. Paediatric clinical practice guideline: otitis media, otitis externa, and mastoiditis. Brighton: Brighton and Sussex University Hospitals NHS Trust, 2020. Available at: www.bsuh.nhs.uk/library/wp-content/uploads/sites/8/2020/09/Paediatric-guidelines-otitis-media-and-externa-and-mastoiditis.pdf
- de Lusignan S, Correa A, Pathirannehelage S et al. RCGP Research and Surveillance Centre Annual Report 2014–2015: disparities in presentations to primary care. Br J Gen Pract 2017; 67 (654): e29–e40.
- Le Saux N, Robinson J; Canadian Paediatric Society, Infectious Diseases and Immunization Committee. Management of acute otitis media in children six months of age and older. Paediatr Child Health 2016; 21 (1): 39–50.
- Schilder A, Chonmaitree T, Cripps A et al. Otitis media. Nat Rev Dis Primers 2016; 2 (1): 16063.
- NICE. Otitis media—acute: how common is it? NICE Clinical Knowledge Summary. cks.nice.org.uk/topics/otitis-media-acute/background-information/prevalence/ (accessed 16 May 2022).
- NICE. Otitis media—acute: how should I make a diagnosis of acute otitis media? NICE Clinical Knowledge Summary. Available at: cks.nice.org.uk/topics/otitis-media-acute/diagnosis/diagnosis/ (accessed 16 May 2022).
- NICE. Otitis media—acute: what else might it be? NICE Clinical Knowledge Summary. Available at: cks.nice.org.uk/topics/otitis-media-acute/diagnosis/differential-diagnosis/ (accessed 16 May 2022).
- Renascience Pharma Ltd. Otigo 40 mg/10 mg/g ear drops, solution—summary of product characteristics. www.medicines.org.uk/emc/product/11888/smpc (accessed 16 May 2022).
- British National Formulary for Children website. Paracetamol. bnfc.nice.org.uk/drug/paracetamol.html (accessed 16 May 2022).
- British National Formulary for Children website. Ibuprofen. bnfc.nice.org.uk/drug/ibuprofen.html (accessed 16 May 2022).
- British National Formulary for Children website. Phenazone with lidocaine. bnfc.nice.org.uk/drug/phenazone-with-lidocaine.html (accessed 16 May 2022).
- Hay A, Downing H, Francis N et al. Anaesthetic–analgesic ear drops to reduce antibiotic consumption in children with acute otitis media: the CEDAR RCT. Health Technol Assess 2019; 23 (34): 1–48.
- Foxlee R, Johansson A, Wejfalk J et al. Topical analgesia for acute otitis media. Cochrane Database Syst Rev 2006; (3): CD005657.
- NICE. Antimicrobial stewardship. NICE Quality Standard 121. NICE, 2016. Available at: www.nice.org.uk/qs121
- Spurling G, Del Mar C, Dooley L et al. Delayed antibiotic prescriptions for respiratory infections. Cochrane Database Syst Rev 2017; (4): CD004417.
- NICE. Otitis media—acute: what are the complications? NICE Clinical Knowledge Summary. cks.nice.org.uk/topics/otitis-media-acute/background-information/complications/ (accessed 16 May 2022).
- Venekamp R, Sanders S, Glasziou P et al. Antibiotics for acute otitis media in children. Cochrane Database Syst Rev 2015; (6): CD000219.
- Thompson P, Gilbert R, Long P et al. Effect of antibiotics for otitis media on mastoiditis in children: a retrospective cohort study using the United Kingdom general practice research database. Pediatrics 2009; 123 (2): 424–430.
- British National Formulary for Children website. Co-amoxiclav. bnfc.nice.org.uk/drug/co-amoxiclav.html (accessed 16 May 2022).
- NICE. Otitis media (acute): antimicrobial prescribing. Information for the public. NICE, 2018. Available at: www.nice.org.uk/ng91/resources/otitis-media-acute-antimicrobial-prescribing-pdf-6204320060101
- NICE. Fever in under 5s: assessment and initial management. NICE Guideline 143. NICE, 2019 (last updated November 2021). Available at: www.nice.org.uk/NG143
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