otitis media review 2010

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REVIEW ARTICLE

Management of children with otitis media: A summary ofevidence from recent systematic reviews jpc_1564 554..563

Hasantha Gunasekera,1,2 Peter S Morris,3 Peter McIntyre2,4 and Jonathan C Craig1,2

1Centre for Kidney Research, The Children’s Hospital at Westmead, 2School of Public Health, University of Sydney, Sydney, 3Menzies School of Health Research

and NT Clinical School, Flinders University, Darwin, 4National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, Sydney,

Australia

Abstract: Health-care professionals who manage children are regularly confronted with clinical questions regarding the management of the

full spectrum of otitis media: acute otitis media; otitis media with effusion; and chronic suppurative otitis media. Given the variety of potential

therapies available, the wide spectrum of middle ear disorders, and the lack of consensus about management strategies, clinicians are in a

difficult position when managing these children. In this review, we seek to summarise the current best evidence for answering otitis media

management questions by collating existing systematic reviews.

Key words: Aboriginal; children; management; otitis media.

Introduction

Middle ear disease in children spans human history. For thou-

sands of years, various treatments for otitis media (OM) have

been suggested, including: goats’ u rine and bats’ wings, incising

the eardrum, vinegar washes, drinking butter and maintaining

silence.1,2 Hippocrates recommended breast milk, sweet wine

and avoidance of smokey rooms, reserving topical therapy withlead powder for severe cases.2 Although OM is very common

worldwide, has a long history and has been the subject of

multiple randomised controlled trials, there remains a great deal

of variability in clinical practice in Australia and around the

world.3–6

Australian health-care professionals need to be familiar with

current evidence for OM management because Indigenous chil-

dren are one of the most at-risk groups in the world. 7–9 Since the

18th century, when letters from Australian settlers documented

profusely draining ears in the local Indigenous children,10

numerous studies have highlighted the discordant OM burden

suffered by Indigenous versus other Australian children, par-

ticularly those living in remote communities.5,7,11,12 Australian

Indigenous children experience OM at a younger age,13,14 and

have more frequent, more severe, more prolonged and more

complicated OM than any other comparable population group

around the world.5–9

OM is not just a major cause of morbidity in Indigenous

children. OM affects nearly every child at least once,15 is one of

the most common causes of health-care presentations,5,15 anti-

biotic prescriptions,5–15 and hearing impairment in children.16

The magnitude of this morbidity burden is highlighted by the

2003 estimate that net costs of OM management total $US 5

billion in the United States17 and are of comparable magnitude

in a recent Australian analysis.18

Health-care professionals who manage children are regularly

confronted with clinical questions regarding the management of

the full spectrum of OM; acute otitis media (AOM), otitis media

with effusion (OME) and chronic suppurative otitis media

(CSOM). Given the variety of potential therapies available, the

wide spectrum of middle ear disorders, and the lack of consen-

sus about management strategies, clinicians are in a difficult

position when managing these children. In this review, we seek

to summarise the current best evidence for answering OM man-

agement questions by collating existing systematic reviews.

Key Points

1 Indigenous children with acute otitis media (AOM) should be

treated with Amoxycillin at the initial visit. Immediate antibiotic

therapy is optional for non-Indigenous children with AOM, but

children younger than 2 years with bilateral disease and those

with otorrhoea are most likely to benefit.

2 Children with otitis media with effusion (OME), and no speech

and language delays, can be observed safely for 3–6 months. If

the effusion has not resolved by then, referral to an Ear Noseand Throat surgeon for ventilation tube insertion should be

arranged for children with bilateral hearing loss >25 dB.

3 Children with chronic suppurative otitis media (CSOM) need ear

cleaning (e.g. dry mopping or betadine washouts) and topical

antibiotics (e.g. ciprofloxacin ear drops) until the discharge

resolves.

Correspondence: Dr Hasantha Gunasekera, General Medicine Depart-

ment, The Children’s Hospital at Westmead, 2145 NSW, Australia. Fax:

+612 9845 1491; email: [email protected]

Accepted for publication 6 April 2009.

doi:10.1111/j.1440-1754.2009.01564.x

Journal of Paediatrics and Child Health 45 (2009) 554–563

© 2009 The Authors

Journal compilation © 2009 Paediatrics and Child Health Division (Royal Australasian College of Physicians)

554



Methods

We performed an electronic search for relevant studies using

Medline (1950 to February 2009) by exploding the term ‘OM’

and limiting to the publication types ‘meta-analysis’ or ‘review’,

and the language field ‘English’. We also searched the Cochrane

database for evidence-based medicine reviews. All systematicreviews which examined any management issue for any form of

OM were included. Only the most recent version of a review

was included when updates had been completed. Reviews iden-

tified from other sources or known to the authors were also

included. Where possible, we presented data on the number of

patients needed to treat per treatment for each outcome of

interest. The search identified two systematic reviews on risk

factors for OM, 14 on management of AOM, 10 on management

of OME, and 3 on other relevant topics.

Risk Factors for OM

There are two systematic reviews of risk factors for AOM and

recurrent AOM19,20 and both identified the presence of siblings,

day-care attendance, exposure to tobacco smoke, pacifier or

‘dummy’ use andlack of breast feeding as significant risk factors.

However, each factor, separately, had only a modest effect (see

Table 1).

Children at high risk of OM and its complications should be

considered differently to the majority of children.21 Australian

Indigenous children have consistently been shown to be at

extremely high risk for severe, complicated OM.6–9,13,14 The

Office of Aboriginal and Torres Strait Islander Health produced

guidelines in 200121, which recommend more aggressive

therapy for Indigenous than other Australian children based on

their higher disease risk (see Therapeutic Guidelines22 and

Table 2.)Another group at high risk of OM and its complications is

children with craniofacial abnormalities, such as cleft palate.19

Diagnosis

A major obstacle to consistent management of OM is the lack of

universally accepted diagnostic criteria (see Fig. 1). In a survey

of 165 clinicians, 147 different clinical definitions of AOM were

provided, with no definition used by more than six clinicians.25

Diagnosis of either AOM or OME requires the presence of an

effusion, which can be reliably detected only by tympanometry

and pneumatic otoscopy.26 Despite this, neither of these tech-

niques is widely used in Australian Aboriginal Medical Ser-

vices.6 We do not have any information on the use of these

diagnostic techniques in other general practice or paediatricsettings in Australia.

Case definitions: AOM (see Fig. 1a)

The Agency for Healthcare Research and Quality, the American

Academy of Pediatrics and the Australian Therapeutic Guide-

lines currently use similar criteria to define AOM. 27,28 The defi-

nition of AOM can be summarised as:

1. Acute onset (within 48 h).

2. Middle ear fluid (such as bulge, absent movement or

bubbles).

3. Signs and symptoms (such as tympanic membrane redness,

otalgia or fever).

OME (see Fig. 1b)

OME can be defined as the presence of middle ear effusion

without signs of acute infection.27 The presence of bubbles (or

an air-fluid level) in the middle ear cavity is a reliable sign of

middle ear effusion but their absence does not reliably exclude

effusion.

CSOM (see Fig. 1c)

CSOM is persistent discharge of pus through a perforated tym-

panic membrane. The duration of ‘persistent’ varies in different

studies. The World Health Organization uses a definition of 2

weeks.9 If the discharge is of shorter duration, the child would

be considered to have AOM with perforation.

Diagnostic Box

Pneumatic otoscopy

Pneumatic otoscopy requires an otoscope and a pneumatic

attachment – an insufflator like the blood pressure cuff bulb. A

small jet of air is pushed into the external ear canal. If there is an

air-tight seal, the air jet will cause the tympanic membrane to

move. If middle ear fluid is present, the tympanic membrane

will either move sluggishly or not at all. Pneumatic otoscopy has

good sensitivity (94%) and specificity (80%) for the detection

of middle ear effusion, using myringotomy findings as the gold

standard, when performed by experienced clinicians. It is used

routinely by clinicians in the United States.26 The pneumatic

attachment can be purchased from your medical supplier for

approximately $20 AUD.

Tympanometry (see Fig. 2)

A tympanometer has a microphone, speaker and manometer.

The speaker emits a constant sound (e.g. at 226 Hz), the ear

canal pressure is varied (+200 to -400 daPa) and the

Table 1 Risk factors for recurrent acute otitis media (AOM)*

Risk factor Risk of RR P value

Family history of AOM AOM 2.6 <0.001

Daycare outside home AOM 2.5 0.003

Not breastfeeding at all Recurrent AOM 2.1 <0.001

At least one sibling Recurrent AOM 1.9 0.001

Child care outside home Recurrent AOM 1.8 0.004

Parental smoking AOM 1.7 <0.001

Family daycare AOM 1.6 0.002

Pacifier use AOM 1.2 0.008

Breast feeding <3 months AOM 1.2 0.003

*Source: Uhari M et al.20

H Gunasekera et al. Management of children with otitis media


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microphone picks up the returning soundwaves. The tympa-

nometer measures the admittance or impedance and also esti-

mates the ear canal volume. Tympanometry involves insertion

of the earpiece into the external ear canal to establish an air-

tight seal. The tympanometer takes a few seconds to generate a

graph Ϯ pressure and volume measurements. When performed

by a experienced operator and using B or C2 curves, tympa-

nometry has good sensitivity (94%) but poor specificity (62%)

for detection of middle ear effusion against myringotomy.26

Specificity can be improved using a different cut-off (static

compensated acoustic admittance of 0.1 mmHo) but this

reduces sensitivity (34%).26 The best results are obtained

when B curves (flat tympanograms) are used as the cut-off for

middle ear effusion (81% sensitivity and 75% specificity).26

Remember: do not attempt tympanometry in the presence of

a discharge.

Table 2 Summary of Australian and international guidelines for antibiotic management of AOM at initial consultation

Guideline For all age groups

Australian OATSIH

Guidelines21

Amoxycillin 50 mg/kg/day for seven days

If perforation, amoxycillin 50–90 mg/kg/day for 14 days

Guideline Infants <6 months Infants 6 months to 2 years Children Ն2 years

Australian Therapeutic

Guidelines

(antibiotic)22

Amoxycillin (45 mg/kg/day) Observation for one day

If vomiting and fever, amoxycillin 45 mg/kg/

day for five days

Observation for two days

If vomiting and fever, amoxycillin 45 mg/kg/

day for five days

American Academy

of Pediatrics23

Amoxycillin (80–90 mg/kg/day) Amoxycillin (80–90 mg/kg/day)

If not severe* and uncertain diagnosis,

observation for two days

Amoxycillin (80–90 mg/kg/day)

If not severe* or uncertain diagnosis,

observation for two days

United Kingdom

NHS Guidelines24

Amoxycillin** (20–40 mg/kg/day)

for five days

Amoxycillin** (20–40 mg/kg/day) for five days

If diagnosis uncertain, observation for three

days

Amoxycillin** (20–40 mg/kg/day) for five days

If not severe*, observation for three days

*Severe = high fever (>39°C), severe pain, perforation, bilateral disease, **The UK guidelines use an age-based rather than weight-based dosing schedule,

so the dosing regimens presented here are estimates. After the observation period, most guidelines recommend starting antibiotics if symptoms persist.

a

c d

b

Fig. 1 Typical middle ear appearances. (a)

Acute otitis media, (b) Otitis media with effusion

with ventilation tube, (c) Chronic suppurative

otitis media, (d) Normal middle ear appearance.

(Images a, b and c courtesy of Professor Harvey

Coates.)

Management of children with otitis media H Gunasekera et al.


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Management (see Fig. 3)

AOM: to treat or not to treat – that is the question(see Table 3)

The debate about whether or not to prescribe oral antibiotics at

the first consultation for AOM still rages. In Australia and North

America, most children are given antibiotics,4,5 whereas in The

Netherlands, Denmark and Norway children are increasingly

managed with ‘watchful waiting’.3 Meta-analyses of antibiotics

show a consistent but small clinical benefit from oral antibiotics

in AOM which needs to be balanced against the similar risk of

side effects. Those ‘for’ antibiotics argue that some of the chil-

dren in the primary studies included in the meta-analyses may

have had OME rather than AOM, which could have diluted the

magnitude of the effect of antibiotics. Those ‘against’ antibiotics

argue that the small benefit from antibiotic therapy is out-

weighed by the harms. It is also likely that in the routine clinicalsetting, as opposed to clinical trials, inadequate or misinter-

preted middle ear examination is much more prevalent, par-

ticularly in young infants.

These reviews have been largely focused on children present-

ingwith the initial symptoms of AOM (ear pain). In the watchful

waiting cases, failures may still end up being treated with anti-

biotics over the next few days. It is also important to emphasise

that all children should be treated for the symptoms of AOM.

There is evidence favouring simple analgesia, such as paraceta-

mol or ibuprofen, but anti-histamines and decongestants,

whether alone or in combination, have no proven benefit and

some proven harms and so are not recommended (see Table 3).

The concern has been raised that this ‘watchful waiting’approach could lead to more suppurative complications of OM,

such as mastoiditis. Antibiotic use for OM in the primary health-

care setting over the last decade has reduced substantially in the

UK. However, a time trend analysis did not show a concomitant

significant increase in the rate of mastoiditis, rheumatic fever or

peritonsillar abscess presentations to hospital. If this is translated

into general practice behaviour, it is estimated that more than

2500 children with OM would need to be treated with antibi-

otics to prevent a single case of mastoiditis. 41 The decreased rates

of mastoiditis and other severe infections are more likely to be

related to other public health measures than to antibiotic use.

At the initial consultation for AOM, clinicians and families

may choose from three broad options: to use oral antibiotics, to

not use oral antibiotics (watchful waiting) or to provide a pre-scription for oral antibiotics, which the family can fill if the

child’s symptoms persist. In one study, only 24% of UK parents

in the delayed prescription group went on to fill the script.42 For

those choosing to treat children with AOM with antibiotics, the

strongest evidence exists for young infants (0–2 years) with

bilateral dise ase and any child with otorrhoea. For the outcomes

of pain and/or fever at 3–7 days, for every 4 children with these

features treated, one child will have pain/fever prevented.31

The Australian Therapeutic Guidelines recommends 5 days of

amoxycillin as first-line treatment if antibiotics are given for

AOM21 but recommends a dose of only 50 mg/kg/day compared

with US recommendations of 80–90 mg/kg/day (see Table 2).

There is no evidence that any antibiotic is superior to amoxy-

cillin, but in cases due to pneumococci with intermediate

resistance to penicillin, doses in the higher dosage range would

be nee ded. Outcomes following 7–10 days courses are similar to

shorter treatment courses.38

OME (‘glue ear’)

The majority of new middle ear effusions will clear spontane-

ously by three months so it is reasonable to wait for this period

of time before instituting additional therapy. There is no evi-

dence to support the immediate use of antibiotics following a

new diagnosis of OME,43 but only 20% of effusions which have

(a)

(b)

(c)

Fig. 2 Tympanogram types. (a) Type A (no effusion). (b) Type B (effusion).

(c) Type C, various subtypes (possible effusion, also referred to as ‘Eusta-

chian tube dysfunction’).



© 2009 The Authors


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been present for three months will clear over the next three

months. In these children, systematic reviews support treating

children with long-term oral antibiotics to hasten resolution,

but the benefits are modest.40,44 There is some evidence for oral

and topical steroids in the short-term but no evidence that they

have an effect in the longer term.45 There is evidence of harm

from decongestants and antihistamines in about 10% of chil-

dren (including gastrointestinal upset, irritability, drowsiness

or dizziness) and these therapies are not recommended (see

Table 4).

Children with prolonged middle ear pathology, such as effu-

sions persisting longer than 3 months and those with associ-

ated hearing impairments should be referred to an Ear Nose

and Throat specialist (ENT). During the ENT consultation, the

PneumaticOtoscopy

Tympanometry

Effusion unlikely

Middle ear

effusion

Establish whether there

are additional featuresof AOM

1 Rapid onset2 Signs and

Symptoms(red TM,

bulging TM,vomiting)

AOM OME

High risk?

1 Indigenous2 Mid- face

abnormalities3 <6 months4 <2 years andbilateral

5 Otorrhoea

• Amoxycillin

(50mg/kg/day) for 7days

• Analgesia

Resolving?

• Observe 2

days

• Analgesia

Further follow up if parental concern

Observe 3 months

If not resolved:arrange

audiogram

If >25dB loss,

consider:

•

•

AntibioticsVentilation

tubes

D I A G N O S I S

M A N A G E M E N T

mobile Type A

Type B

immobile or sluggish

Yes No

NoYes

No

YesFig. 3 Simplified flowchart of management options for otitis

media with intact tympanic membrane. AOM, acute otitismedia; OME, otitis media with effusion (glue ear); TM, tym-

panic membrane.



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benefits and harms of inserting ventilation tubes and, in recur-

rent cases, adenoidectomy should be discussed with the family.

Ventilation tubes reduce the mean time with effusion by 32%

over the next year50 and improve hearing, particularly over the

6–9 months post-operation.50 Theoretically, transient improve-

ment in hearing is most likely to benefit very young children at

a critical stage of language development. The benefits need to

be weighed against the risks of surgery. However, risks are low

in a specialised centre with paediatric anaesthetists and

adequate follow-up.52 Tympanosclerosis (or tympanic mem-

brane scarring) is common after surgery, but not clinically

important. Ventilation tubes are complicated by persistent per-

foration in 2% of children with short-term tubes and up to

17% with long-term tubes52. Some of these perforations

develop into chronic ear discharge. Insertion of ventilation

tubes is now by far the most important risk factor for CSOM in

developed countries.53 Finally, despite short-term improvement

in hearing, there is no evidence for long-term improvement

in either hearing or language development,54 although these

findings may not be generalisable to the Australian context

and in particular to disadvantaged Australian Indigenous

children.

Table 3 Systematic reviews on AOM management

Review year

(source)

Included

studies

Review population Comparison Outcome measures and results (95% confidence

intervals)

Thanaviratananich

2008 (Cochrane)29

6 RCTs 1601 children

(0–12 years)

One or two daily doses vs.

Three or four daily doses ofAmoxycillin (+-clavulanate)

• Too much risk of bias associated with evidence to

make recommendations

Coleman 2008

(Cochrane)30

15 RCTs 2695 children Decongestant/antihistamines

vs other

• NNT = 10 with combined decongestant-

antihistamine to prevent recurrent AOM*

• Five to eight fold increased risk of side effects

• No benefit in early cure rates, symptom resolution,

prevention of surgery or other complications

Rovers 2006

(Lancet)31


(6 m to 12 years)

Antibiotics vs. other For less pain/fever at 3 to 7 days:

• NNT = 3 for children with otorrhoea

• NNT = 4 for children 0–2 years & bilateral AOM

• NNT = 8 for children without otorrhoea

Leach 2006

(Cochrane)32

16 RCTs 1483 children at

increased risk AOM

Ն6 w antibiotics vs. placebo • Need to give 5 children long-term prophylaxis to

prevent 1 child experiencing AOM on treatment

each year

Foxlee 2006(Cochrane)33 4 RCTs Adults and children Analgesic otic preparation

without antibiotics

vs.Placebo or non-analgesic

• Insufficient evidence to make recommendations

Glasziou 2004

(Cochrane)34

8 RCTs 2287 chi ldren Anti microbial s vs. Placebo • No reduction i n pain at 24 h

• 30% relative reduction (19–40%) pain at 2–7 days

• NNT = 15 to prevent pain at 2–7 days

Spurling 2004

(Cochrane)35

9 RCTs Children and adults Delayed antibiotics vs. No or

immediate antibiotics

• Pain and malaise were reduced in the immediate

group vs. delayed group on day 3 but not after.

• No difference in long-term outcomes (earache,

hearing, reconsultation rates)

• Reduced parent satisfaction, OR = 0.51 (0.35 to

0.73).

Rosenfeld 2003

(Laryngoscope)36

63 RCTs

and cohort

8101 children

(6 m–20 years)

Natural history of untreated

AOM

• 61% had symptom relief within 24 h

• 80% spontaneous resolution by 3 days in untreated

Takata 2001

(Pediatrics)37

9 RCTs >1518 children

(1 m–18 years)

Antibiotics vs. Other • NNT = 8 to prevent clinical failure at 2–7 days

Kozyrskyj 2000

(Cochrane)38

30 RCTs 1524 children with

AOM (1 m–18 years)

Antibiotic course <7 days vs.

Antibiotic course >7 days

• Long term outcomes were similar following a 5 day

course of antibiotics compared with a 8–10 day

course

Rosenfeld 1994

(J Ped)39

33 RCTs 5400 chi ldren

(1 m–18 years)

Antibiotics vs. Other • NNT = 7 to prevent clinical failure 7–14 days

Williams 1993

(JAMA)40

9 studie s 958 ch ildre n Prophylacti c antibioti cs vs.

Other

• NNT = 9 to prevent one having recurrent AOM

*Higher quality studies showed no benefit and no study with allocation concealment showed any benefit.

AOM, acute otitis media; NNT, number needed to treat; OR, odds ratio; RCT, randomised controlled trials.



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General measures to maximise the ability of affected children

to hear in the home and school environment should also be

used. These include advising the teachers to allow the children

to sit closer to the front of the class, advising the parents and

teachers to speak to the children face-to-face, and providing

temporary hearing aids or amplification systems in more severe

cases. Parents need to understand that while their child has a

middle ear effusion they will not hear well and behaviour prob-

lems may arise from frustration.

CSOM (Table 5)

CSOM should be treated with ear cleaning (‘ear toilet’) and

topical antibiotic drops. Ear cleaning can be achieved using

tissue spears (dry mopping) or by irrigating the external ear. In

Western Australia, betadine syringing is also common practice.

In the past, Sofradex drops® (dexamethasone-framycetin-

gramicidin) has been the mainstay of therapy. However, there

has been concern about the prolonged use of potentially oto-

toxic compounds in the presence of a perforation. Ciprofloxacin

drops are more effective in Indigenous children58 and have been

listed on the PBS. Ciprofloxacin drops are restricted on the

Pharmaceutical Benefits Scheme (PBS) to Aboriginal and Torres

Strait Islander children over one month of age. The consensus is

that the huge burden of OM disease in the Indigenous popula-

tion overrides any concerns about the development of drug

resistance.

While topical antibiotics are superior to oral antibiotics, the

role of oral antibiotics in additional to topical antibiotics is

uncertain. If chronicity is possible or if the perforation is very

small, the child should be treated with topical and oral antibi-

otics (as for AOM with perforation).55 For children with estab-

lished CSOM, topical antibiotics alone are recommended.55 A

recent Dutch study showed a reduction in discharge when oral

cotrimoxazole was added to standard topical therapy. This

benefit did not persist after the oral antibiotics were ceased.53

Conclusion

The management of OM, as with other conditions, should be

based on the best available evidence. Evidence from sys-

tematic reviews provide a solid foundation for making man-

agement decisions, but clinicians also need to consider the

individual circumstances of their own patient populations. In

Table 4 Systematic reviews on OME management

Review year

(source)

Included

studies

Review

population

Comparison Outcome measures and results (95% confidence intervals)

McDonald 2009

(Cochrane)46

2 RCTs 148 children Ventilation tubes vs. Other • Significant increase in children with no AOM in first 6 months

after surgery in one trial (P < 0.001) but non-significantincrease in other trial.

Perera 2006

(Cochrane)47

6 RCTs Children and adults

(most <16 years)

Autoinflation devices (any) vs.

other

• Non-significant improvements in tympanometry and

audiometry

• No side effects noted

Griffin 2006

(Cochrane)48

16 RCTs 1737 people

(most <18 years)

Antihistamines decongestants

or combination vs. other

• No benefit for any combination of interventions for any

outcome measure

• Treated subjects had 11% more side effects

Thomas 2006

(Cochrane)45


(0–15 years)

Steroids (oral or nasal) vs.

other

• Both oral and topical intranasal steroids lead to quicker

resolution of OME in the short-term

• No evidence of longer term benefit

Rovers 2005

(Archives)49

7 RCTs 1234 children Meta-analysis of interactions

between treatment options

• The effects of conventional ventilation tubes in children

studied so far are small and limited in duration

Lous 2005

(Cochrane)

50


(0–14 years)

Ventilation tubes (grommets)

vs. Myringotomy ornon-surgical treatment

• Grommets reduced time with effusion by 32% (17–48%) over

next year• Grommets improved hearing levels modestly over next 6 m

• Grommets increased risk of tympanosclerosis by 0.33

(0.21–0.45) 1 to 5 years later

Kay 2001

(HNS)51

64 RCTs

70 case

series

39 882 children Ventilation tubes for otitis

media

• Chronic perforation in 4.8% ears after tube insertion

• Chronic otorrhoea in 3.8% children after tube insertion

Cantekin 1998

(ORL)43

8 RCTs 1292 children Antibiotics vs. Other • No effect on short-term resolution of effusion

Williams 1993

(JAMA)40

12 studies 1697 children Antibiotics vs. Other • NNT = 6 to resolve effusion in short-term

• No evidence for long-term resolution

Rosenfeld 1992

(HNS)44

10 RCTs 1325 children Antibiotics vs. Other • NNT = 4 for children with chronic bilateral effusions to prevent

ongoing effusion at next assessment

AOM, acute otitis media; NNT, number needed to treat; OME, otitis media with effusion; RCT, randomised controlled trial.



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this review we have synthesised the current evidence regarding

OM management from recent systematic reviews, so that health-

care professionals managing these children can make informed

decisions and can discuss the pros and cons of the different

management options with the child’s parents and carers.

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19 Lubianca Neto JF, Hemb L, Silva DB. Systematic literature review of

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21 Morris P, Ballinger D, Leach A et al. Recommendations for Clinical

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22 Antibiotic Expert Group. Therapeutic Guidelines. Antibiotic. Version

13. Melbourne: Therapeutic Guidelines Limited, 2006.

23 Academy Academy of Pediatrics Subcommittee on Management of

Acute Otitis Media. Diagnosis and management of acute otitis media.

Pediatrics 2004; 113: 1451–65.

Table 5 Other systematic reviews on OM

Review year

(source)

Included studies Review population Comparison Outcome measures and results (95% confidence

intervals)

MacFadyen 2006

(Cochrane)55

9 RCTs 833 people with CSOM

(various definitions)

Any systemic vs. Any

topical treatments

• Topical quinolone antibiotics better than systemic

antibiotics at clearing discharge at 1–2 weeks (RR3.2, 1.9–5.5)

Roberts 2004

(Pediatrics)56

14 prospective

studies or RCTs

Children with OME

during early

childhood

Speech and language

abilities in preschool

• OME and the related hearing loss showed a small

but statistically significant correlation with lower

receptive and expressive language scores.

Abes 2003

(ORL)57

9 RCTs 2 cohort

studies

1484 children and

adults

Ofloxacin otic solution Vs.

Any other treatment

• Overall cure rate better with Ofloxacin 0.3% otic

drops for CSOM (OR 2.73, 1.52–4.90) vs. other

non-fluoroquinolone ear drops

CSOM, chronic suppurative otitis media; OR, odds ratio; RCT, randomised controlled trials; RR, relative risk.



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24 SIGN. Diagnosis and management of childhood otitis media in primary

care. A national clinical guideline, 2003. Available from: http://

www.sign.ac.uk. [accessed April 2004].

25 Hayden GF. Acute suppurative otitis media in children. Diversity of

clinical diagnostic criteria. Clin. Pediatr. 1981; 20: 99–104.

26 Takata GS, Chan LS, Morphew T, Manqione-Smith R, Morton SC,

Shekelle P. Evidence assessment of the accuracy of methods of

diagnosing middle ear effusion in children with otitis media with

effusion. Pediatrics 2003; 112 (6pt1): 1379–87.

27 Takata GS, Chan LS, Shekelle P et al. Diagnosis, Natural History, and

Late Effects of Otitis Media with Effusion. Evidence Report/Technology

Assessment: Number 55. AHRQ publication number 02-EO26.

Rockville, MD: Agency for Healthcare Research and Quality, 2002.

28 Gates GA, Klein JO, Lim DJ et al. Recent advances in otitis media, 1:

definitions, terminology, and classification of otitis media. Ann. Otol.

Rhinol. Laryngol. 2002; 111: 8–18.

29 Thanaviratananich S, Laopaiboon M, Vatanasapt P. Once or twice

daily versus three times daily amoxicillin with or without clavulanate

for the treatment of acute otitis media. Cochrane Database Syst.

Rev. 2008; Issue 4. Art. No.: CD004975. DOI: 10.1002/

14651858.CD004975.pub2.

30 Coleman C, Moore M. Decongestants and antihistamines for acuteotitis media in children. Cochrane Database Syst Rev. 2008; Issue 3.

Art. No.: CD001727. DOI: 10.1002/14651858.CD001727.pub4.

31 Rovers MM, Glasziou P, Appelman CL et al. Antibiotics for acute otitis

media: a meta-analysis with individual patient data. Lancet 2006; 368:

1429–35.

32 Leach AJ, Morris PS Antibiotics for the prevention of acute and

chronic suppurative otitis media in children. Cochrane Database Syst.


14651858.CD004401.pub2.

33 Foxlee R, Johansson AC, Wejfalk J, Dawkins J, Dooley L, Del Mar C.

Topical analgesia for acute otitis media. Cochrane Database Syst.


14651858.CD005657.pub2.

34 Glasziou PP, Del Mar CB, Sanders SL, Hayem M. Antibiotics for acute

otitis media in children. Cochrane Database Syst. Rev. 2004;CD000219.

35 Spurling GKP, Del Mar CB, Dooley L, Foxlee R. Delayed antibiotics for

symptoms and complications of respiratory infections. Cochrane

Database Syst. Rev. 2004; Issue 4. CD004417.

36 Rosenfeld RM, Kay D. Natural history of untreated otitis media.

Laryngoscope 2003; 113: 1645–57.

37 Takata GS, Chan LS, Shekelle P, Morton SC, Mason W, Marcy SM.

Evidence assessment of management of acute otitis media. I. The role

of antibiotics in treatment of uncomplicated acute otitis media.

Pediatrics 2001; 108: 239–47.

38 Kozyrskyj A, Hildes-Ripstein GE, Longstaffe SE et al. Short course

antibiotics for acute otitis media. Cochrane Database Syst Rev. 2000,

Issue 2. Art. No.: CD001095. DOI: 10.1002/14651858.CD001095.

39 Rosenfeld RM, Vertees JE, Carr J et al. Clinical efficacy of antimicrobial

drugs for acute otitis media: metaanalysis of 5400 children fromthirty-three randomized trials. J. Pediatr. 1994; 124: 355–67.

40 Williams RL, Chalmers TC, STange KC, Chlamers FT, Bowlin SJ. Use of

antibiotics in preventing recurrent acute otitis media and in treating

otitis media with effusion. A meta-analystic attempt to resolve the

brouhaha. JAMA 1993; 270: 1344–51.

41 Sharland M, Kendall H, Yeates D et al. Antibiotic prescribing in general

practice and hospital admissions for peritonsillar abscess, mastoiditis,

and rheumatic fever in children: time trend analysis. BMJ 2005; 331:

328–9.

42 Little P, Gould C, Williamson I, Moore M, Warner G, Dunleavey J. A

pragmatic randomised controlled trial of two prescribing strategies

for acute otitis media. BMJ 2001; 322: 336–42.

43 Cantekin EI, McGuire TW. Antibiotics are not effective for otitis media

with effusion reanalysis of meta-analyses. Otorhinolaryngol. Nova.

1998; 8: 214–22.

44 Rosenfeld RM, Post JC. Meta-analysis of antibiotics for the treatment

of otitis media with effusion. Otolaryngol. Head Neck Surg. 1992; 106:

3780386.

45 Thomas CL, Simpson S, Butler C, van der Voort J. Oral or topical nasal

steroids for hearing loss associated with otitis media with effusion in

children. Cochrane Database Syst. Rev. 2006; Issue 3. Art. No.:

CD001935. DOI: 10.1002/14651858.CD001935.pub2.

46 McDonald S, Langton Hewer CD, Nunez DA. Grommets (ventilation

tubes) for recurrent acute otitis media in children. Cochrane Database

Syst. Rev. 2008, Issue 4, Art. No.: CD004741. DOI: 10.1002/

14651858.CD004741.pub2.

47 Perera R, Haynes J, Glasziou P, Heneghan CJ. Autoinflation for hearing

loss associated with otitis media with effusion. Cochrane Database

Syst Rev. 2006, Issue 4, Art. No.: CD006285. DOI: 10.1002/

14651858.CD006285.

48 Griffin G, Flynn CA, Bailey RE, Schultz JK Antihistamines and/or

decongestants for otitis media with effusion (OME) in children.

Cochrane Database Syst. Rev. 2006, Issue 4, Art. No.: CD003423. DOI:

10.1002/14651858.CD003423.pub2.49 Rovers MM, Black N, Browning GG, Maw R, Zielhuis GA, Haggard MP.

Grommets in otitis media with effusion: an individual patient data

meta-analysis. Arch. Dis. Child 2005; 90: 480–5.

50 Lous J, Burton MJ, Felding J, Ovesen T, Rovers M, Williamson I.

Grommets (ventilation tubes) for hearing loss associated with otitis

media with effusion in children. Cochrane Database Syst. Rev. 2005;

Issue 1. Art. No.: CD001801. DOI: 10.1002/14651858.CD001801.

pub2.

51 Kay DJ, Nelson M, Rosenfeld RM. Meta-analysis of tympanostomy tube

sequelae. Otolaryngol. Head Neck Surg. 2001; 124: 374–80.

52 American Academy of Pediatrics. Clinical practice guideline otitis

media with effusion. Pediatrics 2004; 113: 1412–29.

53 van der Veen EL, Rovers MM, Albers FWJ, Sanders EAM, Schilder

AGM. Effectiveness of Trimethoprim/sulfamethoxazole for children

with chronic active otitis media: a randomized, placebo-controlledtrial. Pediatrics 2007; 119: 897–904.

54 Paradise JL, Feldman HM, Campbell TF et al. Tympanostomy tubes

and developmental outcomes at 9 to 11 years of age. NEJM 2007;

356: 248–61.

55 Macfadyen CA, Acuin JM, Gamble CL Systemic antibiotics versus

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56 Roberts JE, Rosenfeld RM, Zeisel SA. Otitis media and speech and

language: a meta-analysis of prospective studies. Pediatrics 2004;

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57 Abes G, Espallardo N, Tong M et al. A systematic review of the

effectiveness of ofloxacin otic solution for the treatment of

suppurative otitis media. Otorhinolaryngology 2003; 65: 106–16.

58 Couzos S, Lea T, Mueller R, Murray R, Culbong M. Effectiveness ofototopical antibiotics for chronic suppurative otitis media in

Aboriginal children: a community-based, multicentre, double-

blind randomised controlled trial. Med. J. Aust. 2003; 179:

185–90.

Clinical Quiz

Q1. Aiden, a 6 year old boy, is brought to you with a

history of recurrent otitis media. His right external ear

canal is full of purulent discharge. What is the most likely

diagnosis and best management strategy?



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A. He has acute otitis externa and should be treated with

ear wicks and topical steroid and antibiotic drops

instilled with tragal pressure.

B. If Aiden is reported to have had the discharge for 2

months he should be treated with regular ear cleaning

and topical antibiotic drops but does not need initial

oral antibiotic therapy.

C. He should be treated with topical ciprofloxacin drops

for chronic suppurative otitis media alone.

D. If the discharge is new he should be treated with topical

antibiotic with corticosteroids as oral antibiotics have

never been shown to improve outcomes in acute otitis

media with otorrhoea.

Q2. Mary is an 18 month old Aboriginal girl from a

remote community. She is brought to you as she has a

developed a low grade fever today and is pulling at her

left ear. On examination you notice that it is her right ear

that is bulging, red, opaque, and does not move on pneu-

matic otoscopy. The left tympanic membrane looks

normal. Which of the following is the best approach?A. She has right acute otitis media and should be started

on oral antibiotics immediately as she comes from a

high-risk group.

B. She has bilateral acute otitis media and should be

started on oral amoxycillin 50 mg/kg/day for 7 days

according to the OATSIH guidelines.

C. She has right otitis media with effusion and needs an

urgent hearing test as she is at risk of long-term learn-

ing disability if ventilation tubes are not provided

within the next 4 to 6 weeks.

D. She has right acute otitis media and could be managed

with watchful waiting as she is over 1 year of age.

Q3. A 3 year old Sudanese refugee child called Majak is

brought to see you for a general health check. He hasopaque tympanic membranes bilaterally. Both eardrums

move sluggishly on pneumatic otoscopy and have flat

tympanograms (Type B). His mother tells you that he

never listens to her and has been very naughty in the last

year. Which of the following is the best approach?

A. He has bilateral effusions and needs tympanostomy

tubes.

B. He has bilateral acute otitis media and should be started

on oral antibiotics immediately as he is from a high risk

group.

C. Flat (Type B) tympanograms are normal. Peaked tym-

panograms are abnormal as the peak is a measure of the

degree of bulging.

D. He has bilateral otitis media with effusion and can be

observed for 3months. He should have a hearing test if

not previously done or if the effusions do not resolve

over the next 3 months.

Clinical Quiz Answers

Q1.

A. Incorrect: Acute otitis media with perforation and chronic

suppurative otitis media are more likely than acute otitis

externa in children.

B. Correct: In the Macfadyen systematic review ear cleaningand topical therapy were the best treatment options for

CSOM.

C. Incorrect: Therapeutic Guidelines (Antibiotic) and the

OATSIH guidelines for Aboriginal children, both recom-

mend ear cleaning (dry mopping with rolled tissue spears)

before instilling drops for CSOM.

D. Incorrect: AOM with otorrhoea is much more likely to

benefit from oral antibiotics than AOM without otorrhoea

[see Rovers review]

Q2.

A. Correct: Aboriginal children with AOM should be treated

with oral amoxycillin [see OATSIH Guidelines from 2001].

B. Incorrect: Her left ear does not have an effusion (a require-

ment for any diagnosis of AOM or OME), so this is unilat-

eral AOM.

C. Incorrect: She is unlikely to have a bilateral hearing loss as

the left ear is normal. There no evidence of long-term learn-

ing benefits from early instillation of ventilation tubes

[Paradise study]). Data from high-risk populations are

lacking.

She has right acute otitis media and could be managed with

watchful waiting as she is over 1 year of age.

D. Incorrect: Aboriginal children with AOM should be treated

with oral amoxycillin [see OATSIH Guidelines from 2001].

For non-Aboriginal children, this approach would be rea-

sonable [see Rovers review].

Q3.A. Incorrect: The majority of middle ear effusions in children

resolve within 3 months and no intervention is required

acutely.

B. Incorrect: The presentation is more consistent with OME

than AOM. Refugee children may be at increased risk due to

poverty and poor general health but African children in

general are not a high-risk group.

C. Incorrect: Flat tympanograms (Type B) accurately indicate

the presence of middle ear effusions and high peaked tym-

panograms (Type A) accurately indicate no effusions. [See

Takata review] Other tympanogram types are not accurate

at predicting effusions.

D. Correct: Children with bilateral effusions will have some

degree of hearing impairment and the parents need to be

aware of this. A hearing test is a good idea in this situation

and is recommended for children with bilateral disease

which does not resolve by 3 months.



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