• Summary
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• Background
• Clinical Diagnosis
• Investigation
• Treatment
• Non-Antimicrobial Treatment
• Empirical Antimicrobial Treatment
• Duration of Treatment
• Switch to oral agent(s)
• Treatment Failure

1. History
Child with new/rapid (days) onset earache and associated loss/reduction in hearing.
In younger children — pulling, tugging, or rubbing of the ear, or non-specific symptoms (such as fever, irritability, crying, poor feeding, restlessness at night, pyrexia cough, or rhinorrhoea).
Often preceding history of upper respiratory symptoms including cough and rhinorrhoea.

2. Examination

• Remove cerumen(wax)/debris blocking the canal under direct vision (competent person only).
• Otoscopic appearances of AOM: bulging tympanic membrane with loss of landmarks; changes in membrane colour (typically red or yellow); perforation, discharge of pus- See diagnosis section.
• Note any inflammation of ear canal and pinna or pus from canal.
• Examine mastoid for tenderness, erythema, and swelling.
• Note any cervical lymph node enlargement.
• Carry out severity assessment including PAWS score, follow algorithm
• Assess for signs of meningitis or altered conscious level (using Glasgow Coma Scale) and follow Guideline for the initial management of a child with a fever and seizure or suspected acute CNS infection if present.
• NB severe sepsis is uncommon in AOM: when the illness is disproportionately severe compared to signs within the ear an alternative/additional cause should be considered (see Management of community-acquired infection of unknown focus in infants and children between 4 weeks and 16 years old and paediatric review should be considered.

AOM has a clinical spectrum extending from a benign self-limiting condition to a prolonged and sometimes complicated disease. For the purpose of this guideline:

Uncomplicated AOM is defined as: Mild pain of <4 days duration and an absence of any “red” or “yellow” alert symptoms (Table 1).

Complicated AOM is defined as: presence of any “red” or “yellow” alert symptoms (Table 1) or any of: severe pain, bilateral infection, mastoiditis, labyrinthitis, intracranial complications or facial nerve palsy.

3. Investigations

Uncomplicated:
No routine investigations.

Complicated:
blood cultures [prior to starting antibiotics]
FBC, CRP, U&E.
Pus sample from ear discharge (see full Investigations section)

4. Non-antimicrobial treatment
Offer analgesia if pain is present. For most children, this is the mainstay of treatment.
Oral Paracetamol 6-hourly is the preferred treatment.
Oral Ibuprofen 8-hourly is an alternative to paracetamol (if no contraindications).

5. Empirical Antimicrobial Treatment
Antimicrobial treatment should be offered to the following groups:

1. Children under 3 months of age
2. Children with AOM who are systemically unwell.
3. All children with complicated AOM.
4. Children with uncomplicated AOM and an underlying medical condition that may alter the natural course of AOM –Down’s syndrome, cleft palate, immunodeficiency or a cochlear implant.

Antimicrobials should not be routinely prescribed for uncomplicated AOM. If antimicrobials are not indicated discuss the reasons and limitations/drawbacks of antimicrobials with child/parents/carer and advise re-consultation if worse/no better in 3 days or the child becomes systemically unwell.

Route: oral antimicrobials are appropriate in most cases but IV therapy may be necessary for more severe infection (e.g. “red features” or vomiting child) – as judged clinically.

Amoxicillin is first line therapy; second line (e.g. true penicillin allergy or recent (last 2 weeks) Amoxicillin treatment) is Clarithromycin .
Co-amoxiclav (Amoxicillin-Clavulanate) should be used if symptoms worsen following 2-3 days of first line choice (and no penicillin allergy) or in cases of mastoiditis.

Doses: Table 2.

6. Duration
5-7 days

7. Referral criteria
Refer to ENT: Children with mastoiditis; if ear discharge (otorrhoea) persists for 2 weeks; if perforation of the tympanic membrane has occurred; if hearing loss persists in the absence of pain or fever; recurrent acute otitis media.

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Acute otitis media is an inflammation of the middle ear, which can affect people of all ages, but is particularly common in young children. It usually causes some earache and temporary (occasionally permanent) hearing loss. Acute otitis media (AOM) is one of the most common diseases in infants and children with a peak incidence between 6 and 15 months of age. Over 75% of episodes of AOM occur in children younger than 10 years of age¹.

AOM and otitis media with effusion (OME) are different stages of a continuum.
AOM is usually a self-limiting infection and the majority of children with uncomplicated infection (see later) will experience symptom resolution within 4-7 days with symptomatic treatment only.

Children with OME experience up to 5 times more episodes of AOM than children without OME. Recurrent AOM is generally defined as three or more episodes of AOM in 6 months, or four or more episodes in a year, with an absence of middle ear disease between episodes.

Both viruses and bacteria can cause AOM and commonly both are present.2 3 There are too few reports to accurately estimate the proportions of each. However, respiratory viral infections usually precede or coincide with AOM in children. In 5-20% the cause of AOM is viral alone and in another 4-20% neither bacteria nor viruses can be isolated.^2-4

The most common bacterial pathogens associated with AOM are Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis.^{2 3 5} Following the introduction of pneumococcal vaccination, the most common bacterial pathogen may be changing from Streptococcus pneumoniae to Haemophilus influenza.⁶ When AOM is associated with Haemophilus influenzae, non-typable strains are most common.⁷

The most common viral pathogens associated with AOM are respiratory syncytial virus and rhinovirus ⁵.

Risk factors for AOM, besides young age, include ⁸

• Passive smoking.
• Daycare (nursery) attendance.
• Use of formula milk (rather than breast milk).
• Craniofacial syndromes (such as Down's syndrome and cleft palate).
• Male sex.
• Genetics.

Severe complications such as mastoiditis (infection of the mastoid bone and air cells), labyrinthitis, meningitis, intracranial sepsis, or facial nerve palsy are rare in otherwise healthy patients from developed countries.⁹
The most common of these conditions, mastoiditis, has been found to occur in less than 1 in 1000 children with untreated AOM ¹⁰. Rarely (0.7% to 3.2%) intracranial spread causing meningitis or a cerebral abscess can occur. Recurrence of AOM has been found to occur more frequently in amoxicillin-treated patients than placebo ¹¹

Meningitis and brain abscesses should be managed according to LTHT guidelines with ENT input as required.

Definitions -for the purposes of this guideline.
Uncomplicated AOM is defined as:
History and examination consistent with AOM AND Mild pain of <4 days duration AND an absence of: “red” or “yellow” alert symptoms (Table 1); severe pain; bilateral infection; mastoiditis; labyrinthitis; facial nerve palsy or intracranial complications.
[Evidence level D]

Complicated AOM is defined as:
History and examination consistent with AOM AND the presence of any “red” or “yellow” alert symptoms (Table 1) OR severe pain OR bilateral infection OR mastoiditis (erythema and tenderness or swelling over the mastoid) OR labyrinthitis OR facial nerve palsy OR intracranial complications.
[Evidence level D]

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Diagnose acute otitis media if there is acute onset of symptoms, including:
In older children — earache.
In younger children — pulling, tugging, or rubbing of the ear, or non-specific symptoms (such as fever, irritability, crying, poor feeding, restlessness at night, pyrexia cough, or rhinorrhoea).
Unfortunately most of the symptoms overlap with the common cold. Ear ache has the highest predictive value for AOM.

On examination:
Assess for signs of systemic sepsis using the Paediatric Acute Warning Score (PAWS) to indicate severity of signs.
Examine tympanic membrane looking for a distinctly red, yellow, or cloudy tympanic membrane.

Examples of Acute Otitis Media

The diagnosis is strengthened by the presence of at least one of the following:

• Bulging of the tympanic membrane, with loss of normal landmarks.
• An air-fluid level behind the tympanic membrane (although this may be difficult to detect).

Fluid level left ear

Perforation of the tympanic membrane and/or discharge (otorrhoea) in the external auditory canal.

Acute Tympanic perforation

Assess local spread to surrounding structures e.g. mastoiditis can occur so assess for spreading pain, erythema, tenderness and mild swelling in the post auricular area. The pinna is classically displaced anterior and upward in acutemastoiditis.

Limited evidence from a systematic review suggests that the most accurate individual symptoms and signs for diagnosing AOM are ear pain; ear rubbing; a cloudy or distinctly red or bulging tympanic membrane; or a distinctly immobile tympanic membrane (on pneumatic otoscopy)¹². Fever, upper respiratory tract symptoms, crying, restless sleep, and irritability are individually less useful, but no studies have assessed the accuracy of several symptoms and signs combined. These findings are limited by bias in the studies included in the review.

Recommendation: Perform tympanometry (a puff of air into the external ear canal and observation for movement of tympanic membrane or, in older children, direct observation of the tympanic membrane during the valsalva manoeuvre) to confirm middle ear fluid.
[Evidence level B].
If the tympanic membrane is immobile, there is a high probability of middle ear fluid, supporting a diagnosis of AOM.

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Acute otitis media is a clinical diagnosis (see diagnosis section), investigations are only required in selected circumstances to determine the extent of infection or to guide antimicrobial therapy.

Recommendation: send a sample of pus in a sterile sample container to microbiology if the tympanic membrane has perforated and pus is present in the ear canal and a patient is being admitted to hospital or has failed previous antimicrobial therapy (ideally collect a sample of pus using a sterile syringe -without a needle). [Evidence level C]

Recommendation: In patients who require intravenous antimicrobial therapy, the following baseline investigations should be performed and repeated according to clinical need: FBC, CRP, U&E
[Evidence level D]

Recommendation: blood cultures should be taken in all children with complicated AOM and signs or symptoms of systemic infection. [Evidence level D]

Recommendation: When intracranial spread is suspected a CT head with contrast should be obtained as the imaging modality. MRI with gadolinium is useful when intracranial involvement is confirmed. [Evidence level B]

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Recommendation: Treat pain and fever with paracetamol or ibuprofen if there are no contraindications.
The majority of children with AOM experience clinical resolution within 4-7 days with symptomatic treatment.

Recommendation: When antimicrobials are not prescribed offer reassurance to child/parents/carers that antimicrobials are not usually needed because they are likely to make little difference to symptoms, may have adverse effects (for example, diarrhoea, vomiting, and rash), and can contribute to antibiotic resistance. [Evidence level C]

Recommendation: Advise the child/parents/carers to re-consult if the condition worsens or if symptoms are not starting to settle within 48 hours. ^{13 14}
NB. Observation is only an option if there is ready access to adequate follow up care. [Evidence level C]

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Recommendation: Antimicrobial treatment should be offered to the following groups¹⁵:

1. All children younger than 3 months of age with possible AOM.
2. All children with complicated AOM.
3. Children with uncomplicated AOM and an underlying medical condition that may alter the natural course of AOM –Down’s syndrome, cleft palate, immunodeficiency or a cochlear implant.
   [Evidence level C/D]

Recommendation: The decision to initially administer antimicrobials via the IV or oral route is a clinical one, based on the severity of infection and likely compliance/tolerance of oral therapy. Children with “red” features (Table 1) would normally require IV therapy.
[Evidence level D]

Recommendation: if an antibiotic is required, amoxicillin is first line therapy. Clarithromycin is the recommended alternative for children who are allergic to penicillins or recently treated with penicillin (in past 2 weeks).
Co-Amoxiclav (Amoxicillin-Clavulanate) should be used for cases of mastoiditis after discussion with ENT
See Table 2 for doses
[Evidence level B]

NB. In a setting with high prevalence of Streptococcus pneumoniae with reduced susceptibility to penicillin high dose amoxicillin (80 mg/kg/day three times a day) remained clinically effective in 82% (n=41) of children with culture-positive AOM caused by a variety of bacterial pathogens (Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis) - including Strep. pneumoniae with reduced susceptibility to penicillin and beta-lactamase-producing H. influenzae.¹⁶

Recommendation: For children who do not meet criteria for current antimicrobial therapy, observation for 3 days and reconsultation if worse or no better is advised.^{13 14}

Directed antimicrobial treatment

Recommendation: If microbiological diagnosis becomes available e.g. via blood cultures or pus samples, therapy should be altered according to susceptibilities or discussed with a Microbiologist.
[Evidence level C]

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Recommendation: 5-7 days course.
[Evidence level A]

Evidence on antibiotic duration
NICE reviewed the evidence for duration in 2018 and again in 2019, where there were no recommendations to change the previous advice. ¹⁹

• A short course of antibiotics (more than 48 hours but less than 7 days) was associated with significantly higher treatment failure at 8 to 19 days, or 1 month or less, compared with a long course (7 days or longer). Treatment failure (defined as a lack of clinical resolution, relapse or recurrence of acute otitis media within 1 month of starting treatment) occurred in 18.0% of the short-course group compared with 14.4% of the long-course group at 8 to 19 days (NNT 28 [range 17 to 77]; very low quality evidence), and in 20.5% of the short-course group compared with 17.5% of the long-course group at 1 month or less (NNT 34 [range 20 to 124]; low quality evidence). However, there was no difference in treatment failure between short and long courses at other time points. This was based on a systematic review and meta‑analysis of RCTs (Kozyrskyj et al. 2010).¹⁹
• There were significantly fewer gastrointestinal adverse events with a short course of antibiotics (more than 48 hours but less than 7 days) compared with a long course (7 days or longer; very low quality evidence). However, this result was based on the reported odds ratio and was not statistically significant when the relative risk was calculated (Kozyrskyj et al. 2010). ¹⁹

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Recommendation: When intravenous therapy has been commenced initially, switch to oral antimicrobials can usually be done safely after 48 hours, provided that local and systemic signs of infection are resolving and any co-morbidities are stabilised.
[Evidence level D]

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Recommendation: AOM not responding to first or second choice antimicrobial therapy or where these agents are contraindicated should be discussed with ENT and microbiology.
[Evidence level D]

Recommendation: Routine follow-up is not required in the absence of persistent symptoms.
[Evidence level D]

Recommendation: Follow up is required when:

1. A no antibiotic prescribing strategy is adopted and there is significant worsening of symptoms or if symptoms are not starting to settle within 4 days of the onset of the illness (GP or hospital)
2. An immediate antibiotic prescribing strategy is adopted and symptoms persist despite completing a course of antibiotics, or if there is significant worsening of symptoms while on therapy (GP or hospital).
3. If discharge from the ear canal (otorrhoea) persists for 2 weeks (ENT)
4. If perforation of the tympanic membrane has occurred (ENT)
5. If hearing loss persists in the absence of pain or fever (ENT)
6. For recurrent acute otitis media (ENT)
   [Evidence level D]

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