Topical vs.

Systemic Treatments
For Acute Otitis Media
Kathy Thornton, Francie Parrish, Christine Swords

cute otitis media (AOM) is a

significant cause of morbidity among the pediatric population. A decade ago, an
estimated 31 million pediatric office
visits occurred, and 3.5 billion dollars
were spent on treatment of patients
with otitis media (Sorrento &
Pichichero, 2001). AOM, the most
common condition treated with
antimicrobial agents in the United
States, is an inflammation of the middle ear caused by bacteria or a virus
moving up the Eustachian tube that
becomes trapped in the middle ear.
This process can cause ear pain and
diminished hearing (Alliance for the
Prudent Use of Antibiotics [APUA],
1999). Many times, the blocked
Eustachian tube will drain spontaneously and clear the infection in the
absence of treatment; however, many
practitioners are quick to prescribe
systemic antibiotic therapy to assist in
clearing the bacteria (APUA, 1999).
Further, some clinicians confuse otitis
media with effusion (OME) with
AOM, which leads to the overuse of
antibiotics and encourages multiple
drug resistance (Cooley, Grossan, &
Hoffman, 2002). In 2004, guidelines
set forth by the American Academy of
Pediatrics (AAP) and the American
Academy of Family Physicians (AAFP)
(2004) included a definition of AOM
offering three components: 1) a history of acute onset of signs and symptoms, 2) the presence of middle-ear
effusion, and 3) signs and symptoms of
middle-ear inflammation (Lieberthal,
2006). In recent years, there has been
a trend away from the prescription of
antibiotics to treat AOM due to growing antibiotic resistance (Foxlee et al.,
2006).

Kathy Thornton, PhD, RN, is an Associate

Professor of Nursing, Georgia Southern
University School of Nursing, Statesboro, GA.
Francie Parrish, MSN, RN, FNP-BC, is
a Family Nurse Practitioner, Youthcare
Pediatrics of Central Georgia, Warner Robins,
GA.
Christine Swords, MSN, RN, FNP-BC, is
a Family Nurse Practitioner, South Coast
Nephrology, Hinesville, GA.

Acute otitis media (AOM) is a common condition in children that is often treated
with systemic antibiotic therapy; however, research suggests that non-complicated AOM will resolve spontaneously using only eardrops. To determine best practice for the use of systematic antibiotics compared to topical treatment of AOM,
a systematic review of evidence was conducted. Cochrane, Medline, CINAHL,
and other databases were searched. Inclusion criteria were studies published
from 1995-2010 that included children with AOM and were randomized controlled
trials (RCTs). Five systematic reviews and five RCTs were included in the review.
Current evidence recommends using topical and other alternative approaches for
treating non-complicated AOM in children 2 years of age or older; however, many
practitioners are not currently following these recommendations for various reasons. Additional research to address these reasons may help determine how to
improve practitioner adherence to best practice evidence and guidelines to help
reduce the unnecessary use of systemic antibiotics.

In an era of rising antibiotic-resistant pathogens causing AOM, it is

important for advanced practice
nurses (APNs) to be accurate in diagnosing and treating AOM. It is imperative for APNs to carefully consider
the approach to infectious disease in
children and select best practices
based on strong evidence (Issacson,
2006). The most current guidelines
from Cincinnati Childrens Hospital
Medical Center (CCHMC) (2004) recommend all children with AOM who
have a positive assessment for pain be
treated with an appropriate analgesic
along with antimicrobial therapy. It is
not clear if the use of topical analgesics along with topical antibiotics
can be as effective compared to treating
AOM with systemic antibiotics or if the
use of topical analgesics alone can be
adequate in effectively treating AOM.
The purpose of the review presented in
this article is to evaluate current evidence and practice in drug treatment of
AOM. The following discussion will
include the development of a PICO
question, appraisal, synthesis, and
application of the evidence to practice
and directions for future research.

Formulating the Question

A PICO format was used to develop
a searchable and answerable clinical
question. A clinical question includes
four elements (PICO): patient population of interest, intervention of interest,
comparison of interest, and outcome of

PEDIATRIC NURSING/September-October 2011/Vol. 37/No. 5

interest. The therapy PICO question for

the current study was, In children age
6 months to 17 years with AOM, is
symptom resolution similar for topical
treatment (antibiotic eardrops and/or
analgesic eardrops) compared to treatment with systemic antibiotics?

Finding and Critically

Appraising the Evidence
To select studies for inclusion in
this review, the Cochrane, National
Guideline Clearinghouse, MEDLINE,
and CINAHL databases were systematically searched for relevant published research. Guided by the PICO
question, the keywords used in various combinations were AOM, systemic antibiotic use, and topical treatments. To further narrow the search,
the terms research and RCT were
added. Inclusion criteria were studies
done within five years and research
that used a pediatric population of
patients 6 months to 17 years of age
who were diagnosed with AOM. Each
study also had to include a comparison of treatment options for AOM.
Eight studies were identified that
addressed AOM therapies, including
systemic antibiotics, topical antibiotics, topical analgesics, topical antiseptics, and a wait and see
approach. Of these eight studies,
there were two meta-analyses, one
systemic review, and five RCTs. Table
1 presents the methods, findings, and
263

Topical vs. Systemic Treatments for Acute Otitis Media

strengths and limitations of each
study.
Specific strengths of the appraised
evidence were the inclusion of the
highest level of evidence, including
systematic reviews and RCTs, and
sample size greater than 100. A few
limitations noted in some studies
were 1) not addressing adverse reactions or safety (Macfadyen, 2005), 2)
using subjective pain scores (Bolt,
Barnett, Babl, & Sharwood, 2008), 3)
lack of reporting statistical support
(Dohar et al., 2006), or 4) addressing
only chronic otitis media instead of
AOM (Couzos, Culbong, Lea, Mueller,
& Murray, 2003). Despite these limitations, the studies overall were well
designed with good validity and reliability, therefore providing sound evidence.

Synthesis and Evaluation

A synthesis of the findings shown
in Table 1 revealed strong support for
the benefits of using topical aural
medication over systemic treatment
for AOM. Topical antibiotic treatment
results in more clinical cures and earlier cessation of symptoms with fewer
adverse effects than oral treatment
(Dohar et al., 2006); topical quinolone antibiotics can clear aural discharge more effectively than systemic
antibiotics (Macfayden, 2005). Further,
topical antibiotics for various stages of
otitis media were found to be more
effective when compared to either 1)
no treatment, 2) boric acid and alcohol drops, 3) placebo saline drops, or
4) steroid drops (Couzos et al., 2003;
Dohar et al., 2006; Macfayden, 2005).
A wait and see approach found 62%
of AOM cases treated with lidocaine
drops were resolved without the use
of systemic antibiotics (Spiro et al.,
2006). Using lidocaine drops for pain
management supports the premise
that if symptoms are treated, many
cases of AOM will resolve spontaneously. Two factors that may affect
this resolution of symptoms, however, must be considered: the presence
of concurrent infections and the
childs age.

Effect of Concurrent Infections

Based on the reviewed evidence, it
is unclear whether topical antibiotics
are effective to treat severe suppurative
AOM. Some studies suggest little middle ear penetration from drops in the
ear canal (Issacson, 2006). In addition,
topical antibiotics have no systemic
effect, and thus, do not treat any concurrent infection (such as pneumonia)
264

known to be associated with otitis

media (Issacson, 2006). Symptoms
may not be permanently relieved if the
underlying problem is not treated.

Impact of Age
A childs age may also have an
impact on the effectiveness of topical
antibiotics compared to systemic
antibiotics. Medical complications
from AOM are most common in children under 2 years of age and can
include mastoiditis, meningitis, and
hearing loss (Leibovitz, 2006). Further, children under 2 years of age
often present with a high incidence of
AOM recurrent disease, immature
anatomic and physiologic airways,
age-related immune humoral and cellular deficiencies, antibacterial-resistance, and a less effective response to
antibiotic treatment (Leibovitz, 2006).
Therefore, much of the evidence
available recommends the use of a
systemic antibiotic in this population
to prevent complications. If the child
is older than 2 years of age, however,
it may be appropriate to use a topical
treatment (CCHMC, 2004).
There is also support for the use of
both topical and systemic treatments
to treat AOM or using the topical first
and subsequently adding on a systemic antibiotic (Spiro et al., 2006).
Although most of the reviewed studies favored a topical treatment of
some sort, it is unclear when it is the
appropriate time to add on a systemic
treatment if needed or when to know
a topical treatment alone may not be
sufficient.
The evidence effectively answers
the PICO question that addressed the
effectiveness of topical treatments,
such as antibiotics and analgesics,
compared to systemic antibiotics in
the resolution of symptoms of AOM.
Research findings support positive
outcomes with topical treatments
compared to systemic treatments in
the resolution of symptoms, quicker
pain relief, more clinical cures, less
discharge, and fewer adverse events
and complications. Additionally, evidence often supported resolution of
AOM with the use of topical analgesics alone (Spiro et al., 2006).

Clinical Guidelines
In 2004, the CCHMC (2004) developed an evidence-based practice
guideline for the medical management of AOM in children 2 months
to 13 years of age. This guideline was
updated based on new evidence in
August 2006 (Lieberthal, 2006), and

includes recommendations important

in assessing, diagnosing, managing,
and treating AOM in children. Table 2
summarizes relevant recommendations from the initial 2004 guideline
and the 2006 updated guideline.
These guidelines are consistent
with clinical recommendations by the
AAP and AAFP (2004). These organizations also suggest that observation
of symptoms in otherwise healthy
children may be a safe and effective
way to treat AOM. Although the AAP
and AAFP guidelines have not been
updated since 2006, the evidence
found in this review supports their
recommendations for not treating
AOM with systemic antibiotics in
many cases and using analgesics for
AOM pain control.

Current Practice
In current practice, there are still
few health care professionals who
actually use an observation method
with or without analgesia when treating AOM and who prefer to use systemic antibiotics (Johnson & Holger,
2007). After the most recent guideline
publication, the rate of AOM encounters at which no antibiotic prescribing
was reported did not change (Coco,
Vernacchio, Horst, & Anderson,
2010). In a recent survey, the reported
reasons for not using an observation
method were parental reluctance and
the additional cost and time required
to follow up with patients being
observed (Vernacchio, Vezina &
Mitchell, 2007). If an antimicrobial
agent is used, high-dose amoxicillin
(80 to 90 mg/kg/d) is the treatment of
choice for most children at the time
of initial presentation unless the disease is particularly severe or the child
has recently failed a previous course
of the antibiotic (Barenkamp, 2006).
This report raises the issue of how to
treat patients appropriately while satisfying parental expectations.
When comparing current practice
to the evidence-based guidelines,
many health care providers are aware
of the recommendation to observe
non-severe AOM in children over 2
years of age, but few adhere to the
guidelines because of parental reluctance when antibiotics are not immediately prescribed. Practitioners also
have concerns of cost and difficulties
of following up with children whose
conditions fail to improve (Barclay &
Vega, 2007).
Based on patient preference and
characteristics of the pediatric population, it would be feasible to use topi-

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PEDIATRIC NURSING/September-October 2011/Vol. 37/No. 5

265

Design: RCT
Interventions: Lignocaine
or saline eardrops

Design: RCT

Bolt et al.
(2008)
Australia

Couzos et
al. (2003)
Australia

Design: RCT

Design: Systemic review

Interventions: Anesthetic
eardrops compared to
olive oil placebo or herbal
eardrops

Dohar et
al. (2006)
U.S.

Foxlee
(2006)
U.S.

Purpose: To determine the effect of antibiotic treatment for acute otitis media in
children
Sample: Various sizes
Setting: Various

Setting: Community in Australia

Sample: N = 147; Aboriginal children

Purpose: To compare the effectiveness

of ototopical ciprofloxacin (CIP) with
framycetin, gramicidin, dexamethasone
(FGD) eardrops in Aboriginal children
with chronic suppurative otitis media

Setting: Tertiary childrens hospital

emergency department

Sample: N = 63; children 3 to 12 years

of age

Purpose: To determine efficacy of

topical aqueous 2% lignocaine eardrops
compared with a placebo (saline) for
pain relief of AOM

Purpose, Sample, and Setting

Purpose: To assess the effectiveness of

topical analgesia for AOM
Sample: Four randomized trials with
various sample sizes
Setting: Various

Setting: No setting identified

Purpose: To compare topical CIP/DEX

Interventions: Ciprofloxacin/ otic suspension to oral AMOX/CLAV
dexamethasone (CIP/DEX) suspension in children with acute otitis
media with otorrhea through tympanosotic suspension to oral
tomy tubes
amoxicillin/clavulanic acid
Sample: N = 80; 6 months to 12 years
(AMOX/CLAV) suspension
of age

Design: Meta-analysis
Interventions: Placebo and
antibiotic

Del Mar et
al. (1997)
Australia

Interventions: Ciprofloxacin
(CIP) eardrops and framycetin, gramicidin, dexamethasone (FGD) eardrops

Design and
Interventions

Study

Intervention period: Various

Outcome measures: Ear pain
Follow up: Various

Follow up: Day 1, 3, 11, and 18

Outcome measures: Cessation of

otorrhea and occurrence of adverse
effects

Intervention period: 10 days

Intervention period: Various

Outcome measures: Pain, deafness,
and other symptoms related to
acute otitis media or antibiotic treatment
Follow up: 3 months

Follow up: 10 to 21 days after treatment started

Outcome measures: Resolution of

otorrhoea (clinical cure), proportion
of children with healed perforated
tympanic membrane (TM) and
improved hearing

Intervention period: 9 days

Intervention period: 30 minutes

Outcome measures: Reduction in
patient pain by 50% of baseline
Follow up: 1 day and 1 week

Intervention Period, Outcome

Measures, and Follow Up

Table 1.
Summary of Reviewed Studies

All four trials showed only marginal

differences between intervention
and placebo groups. Insufficient to
reach convincing statistical significance.

Topical otic treatment with CIP/DEX

otic suspension is superior to treatment with oral AMOX/CLAV suspension and results in more clinical
cures and earlier cessation of otorrhea with fewer adverse effects in
children with AOM with otorrhea
through tympanostomy tubes.

Sixty percent (60%) of children

treated with placebo were pain-free
within 24 hours of presentation and
were not influenced by antibiotics.
Early use of antibiotics provided
only modest benefit for AOM: to
prevent one child from experiencing
pain by 2 to 7 days after presentation, 17 children must be treated
with antibiotics early.

Ciprofloxacin eardrops were 47%

more likely to cure chronic suppurative otitis media than combined
framycetin, gramicidin, and dexamethasone eardrops.

Topical aqueous 2% lignocaine

eardrops provided rapid relief for
many young children presenting
with ear pain attributed to AOM.

Findings and Conclusions

Strengths: All were double-blind

randomized or quasi-randomized
controlled trials.

Limitations: No confidence intervals or level of significance reported; small sample size.

Strengths: Randomized, observermasked, parallel-group; all 80 participants completed the follow up.

Strengths: Studies were randomized and controlled; included side

effects and adverse reactions.

Limitations: To allow for a 30%

loss to follow up, 300 children
were needed (30 to 60 per recruitment site).

Strengths: Randomized; adverse

reactions and safety issues were
addressed.

Strengths: Double blind, randomized, and placebo-controlled.

Limitations: Pain scores were
measured using the Bieri faces
pain scale and visual analogue
scale (subjective); small sample
size.

Strengths and Limitations

266

Interventions: Prescribing
systemic antibiotics
immediately after
diagnosis of AOM versus
waiting 48 hours to see if
symptoms resolve
spontaneously. All patients
received ibuprofen and otic
analgesic drops for use at
home.

Design: RCT

Note: RCT = randomized control trial.

Spiro et al.
(2006)
U.S.

Setting: Pediatric emergency

department of a large hospital in NE

Sample: N = 283; children 6 months to

12 years of age

Purpose: To determine whether the

treatment of AOM using a wait and see
method significantly reduces the use of
antibiotics compared with a standard
antibiotic prescription and to evaluate
the effects of this intervention on
clinical symptoms and adverse
outcomes related to antibiotic use

Setting: Various schools in Kenya

Sample: N = 427; school-aged children

Follow up: 4 to 6 days and 30 to 40

days after enrollment

Outcome measures: Filling of the

antibiotic prescription and clinical
course

Intervention period: 3 days

Follow up: 2 and 4 weeks after

treatment

Outcome measures: Resolution of

discharge, healing of the tympanic
membrane, and change in hearing
threshold from baseline

Intervention period: 2 weeks

Purpose: To compare a topical

quinolone antibiotic (ciprofloxacin) with
a cheaper topical antiseptic (boric acid)
for treating chronic suppurative otitis
media in children

Design: RCT

Macfadyen
et al.
(2005)
UK

Interventions: Topical
ciprofloxacin and boric acid
in alcohol

Intervention period: Various

Outcome measures: Clearing of
aural drainage.
Follow up: Various

Intervention Period, Outcome

Measures, and Follow Up

Purpose: To compare systemic

antibiotic therapy with antibiotic
eardrops in treating chronically
discharging ears with an underlying
eardrum perforation

Purpose, Sample, and Setting

Design: Meta-analysis
Interventions: Topical
treatment versus systemic
antibiotics

Design and
Interventions

Macfadyen
(2005)
U.S.

Study

Table 1. (continued)
Summary of Reviewed Studies

Conclusion: The wait and see

approach may substantially reduce
unnecessary use of antibiotics in
children with AOM.

Sixty-two percent (62%) of the

wait and see group did not fill the
antibiotic prescription, and there
was no statistically significant
difference between the groups in
frequency of subsequent fever,
otalgia, or unscheduled visits for
medical care.

Ciprofloxacin performed better than

boric acid and alcohol for treating
chronic suppurative otitis media.

Topical quinolone antibiotics can

clear aural drainage better than
systemic antibiotics. Non-quinolone
topical treatment results were less
clear.

Findings and Conclusions

Limitations: Parents were not

blinded to which group their child
was in.

Strengths: Randomized physician

recruiters and interviewers were
blinded; large sample size; 94% of
the antibiotic group and 98% of
the wait and see group
completed the study.

Strengths: Randomized; 97% of

participants completed the study.

Strengths: All studies were

randomized.
Limitations: Evidence regarding
safety was weak.

Strengths and Limitations

Topical vs. Systemic Treatments for Acute Otitis Media

cal treatment, such as antibiotic

and analgesic eardrops, as the firstline treatment for children. Topical
analgesics help relieve symptoms
that are very troubling to children
(such as pain, irritability), and topical antibiotics may be better tolerated in the pediatric population.
Systemic antibiotics have also been
found to almost double the rate of
diarrhea, vomiting, and rash (Del
Mar, Glasziou, & Hayem, 1997).
When incorporating treatment
guidelines into clinical practice,
family education is critical. To effectively use topical treatments and
observation for managing AOM, it
is imperative for parents to understand the importance of using systemic antibiotics wisely and that
other treatment options may be just
as effective. Parents should be educated, such as by providing educational handouts with simple, clear
information about AOM treatment
options based on practice guidelines and current evidence. It is also
essential to educate parents about
the signs and symptoms that may
indicate the need for a systemic
antibiotic instead of topical medication or observation only. Even with
parent education, however, follow
up by the health care provider is
critical. Ideally, parents could be
contacted 24 to 48 hours after their
initial office, clinic, or emergency
department visit to assess the childs
status and prescribe systemic antibiotics if indicated.

Future Research

AOM is one of the most common

conditions treated among children
in the United States (Cooley et al.,
2002) and warrants additional
research to identify the most efficacious treatment of this problem.
More research is especially needed
comparing the use of topical antibiotics versus systemic antibiotics in
actually resolving AOM and not just
relieving symptoms. If the underlying infection is effectively treated,
then the pain, fullness, and other
AOM symptoms will be resolved.
Research conducted on non-pharmacological approaches, such as the
wait and see approach, could also
be beneficial in determining if treatment for non-severe AOM is actually indicated.
Not all of the reviewed studies
directly addressed the PICO question. Some studies did not specifically address the comparison of topical treatments to systemic treat-

PEDIATRIC NURSING/September-October 2011/Vol. 37/No. 5

Table 2.
Acute Otitis Media (AOM) Treatment Recommendations from the
2004 Guideline and 2006 Updates
Document

Recommendations

2004 Evidence-Based
Clinical Practice Guideline for
Medical Management of AOM
in Children 2 Months to 13
Years of Age: Summary of
Recommendations (CCHMC,
2004)

For children older than 2 years of age with AOM

and who appear well, treatment options should
be discussed with the family and the family
should be involved in the decision making.

2006 Update of EvidenceBased Clinical Practice Guideline for Medical Management of

AOM in Children 2 Months to
13 Years of Age: Summary of
Recommendations (Lieberthal,
2006)

For children older than 2 years of age with AOM

who appear well, the treatment options should
include observation along with a safety net
antibiotic prescription (SNAP) that should be
discussed with the family and involve the family in
the decision making.

Treatment with a 10-day course of antibiotics for

children younger than 2 years of age with AOM.
Treat all children with AOM who have a positive
assessment for pain with an appropriate
analgesic.

For children older than 2 years of age, parents

should be given a SNAP for a 5-day course of
antibiotics and instructed to fill only if symptoms
do not resolve within 48 to 72 hours.

ments, and other studies included

chronic otitis media. Further research
in the areas of suppurative and concurrent infections and childs age
would be beneficial to determine best
practice evidence.
The PICO question posed was
answered by appraising relevant
research and applying valid evidence
to support topical treatments were
effective in resolving the symptoms of
AOM without the use of systematic
antibiotics. These results are in line
with current practice guidelines for
AOM management. Practitioners
report that the most frequent barriers
to not following current guidelines
were parental reluctance not to have
antibiotics prescribed for their children and the additional cost and time
of following up with children who fail
to improve (Barclay & Vega, 2007).
Continuing research is needed to
determine the effectiveness of topical
antibiotics compared to systemic
antibiotics in resolving AOM versus
palliative treatments to decrease pain.
Patient care should be individualized.
Certain factors, such as patient preferences, severity of symptoms, and acuity of the disease process, need to be
considered when treating AOM with a
topical or systemic treatment.

Nursing Implications
Balancing the use of best practice
evidence and parent preference is crucial to the efficacy of treating AOM.
Nurses must educate parents to
understand that topical eardrops are a
safe and effective treatment option
for non-severe AOM and to be aware
of signs and symptoms of a worsening
condition needing follow up with the
health care provider. Further, parents
anxiety could be decreased knowing
they would be contacted within 24 to
48 hours to assess the childs need for
systemic antibiotics. If nurses helped
parents to be more informed and less
anxious, clinicians would be better
able to follow recommended guidelines for AOM and avoid unnecessary
use of systemic antibiotics.
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Additional Readings
Dupre, S., Bikhazi, N., Carroll, S., Crenshaw,
K., Giles, W., McLean, C., Wall, M.
(2006). Topical ciprofloxacin/dexamethasone superior to oral amoxicillin/
clavulanic acid in acute otitis media with
otorrhea through tympanostomy tubes.
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