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REVIEW ARTICLE
Management of children with otitis media: A summary ofevidence from recent systematic reviewsjpc_1564 554..563
Hasantha Gunasekera,1,2 Peter S Morris,3 Peter McIntyre2,4 and Jonathan C Craig1,2
1Centre for Kidney Research, The Childrens 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 urine 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.36
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. 79 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.59
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,515 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 36 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 Childrens Hospital at Westmead, 2145 NSW, Australia. Fax:
+612 9845 1491; email: hasanthg@chw.edu.au
Accepted for publication 6 April 2009.
doi:10.1111/j.1440-1754.2009.01564.x
Journal of Paediatrics and Child Health 45 (2009) 554563
2009 The Authors
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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 and lack 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.69,13,14 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
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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 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
Guidelines21Amoxycillin 50 mg/kg/day for seven days
If perforation, amoxycillin 5090 mg/kg/day for 14 days
Guideline Infants 39C), 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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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
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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
69 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
(012 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)3015 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)316 RCTs 1643 children
(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 02 years & bilateral AOM
NNT = 8 for children without otorrhoea
Leach 2006
(Cochrane)3216 RCTs 1483 children at
increased risk AOM
6 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 preparationwithout antibiotics
vs.Placebo or non-analgesic
Insufficient evidence to make recommendations
Glasziou 2004
(Cochrane)348 RCTs 2287 chi ldren Anti microbial s vs. Placebo No reduction i n pain at 24 h
30% relative reduction (1940%) pain at 27 days
NNT = 15 to prevent pain at 27 days
Spurling 2004
(Cochrane)359 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)3663 RCTs
and cohort
8101 children
(6 m20 years)
Natural history of untreated
AOM
61% had symptom relief within 24 h
80% spontaneous resolution by 3 days in untreated
Takata 2001
(Pediatrics)379 RCTs >1518 children
(1 m18 years)
Antibiotics vs. Other NNT = 8 to prevent clinical failure at 27 days
Kozyrskyj 2000
(Cochrane)3830 RCTs 1524 children with
AOM (1 m18 years)
Antibiotic course 7 days
Long term outcomes were similar following a 5 day
course of antibiotics compared with a 810 day
course
Rosenfeld 1994
(J Ped)3933 RCTs 5400 chi ldren
(1 m18 years)
Antibiotics vs. Other NNT = 7 to prevent clinical failure 714 days
Williams 1993
(JAMA)409 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.
H Gunasekera et al. Management of children with otitis media
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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)476 RCTs Children and adults
(most
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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 childs parents and carers.
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Table 5 Other systematic reviews on OM
Review year
(source)
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intervals)
MacFadyen 2006
(Cochrane)55
9 RCTs 833 people with CSOM
(various definitions)
Any systemic vs. Any
topical treatments
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Roberts 2004
(Pediatrics)5614 prospective
studies or RCTs
Children with OME
during early
childhood
Speech and language
abilities in preschool
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but statistically significant correlation with lower
receptive and expressive language scores.
Abes 2003
(ORL)579 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, 1.524.90) 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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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.
H Gunasekera et al. Management of children with otitis media
Journal of Paediatrics and Child Health 45 (2009) 554563
2009 The Authors
Journal compilation 2009 Paediatrics and Child Health Division (Royal Australasian College of Physicians)
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