Professional Documents
Culture Documents
ABSTRACT. This evidence-based clinical practice a significant impact on the health of children, cost of
guideline provides recommendations to primary care cli- providing care, and overall use of antibacterial
nicians for the management of children from 2 months agents. The illness also generates a significant social
through 12 years of age with uncomplicated acute otitis burden and indirect cost due to time lost from school
media (AOM). and work. The estimated direct cost of AOM was
The American Academy of Pediatrics and American
Academy of Family Physicians convened a committee $1.96 billion in 1995. In addition, the indirect cost
composed of primary care physicians and experts in the was estimated to be $1.02 billion.1 During 1990 there
fields of otolaryngology, epidemiology, and infectious were almost 25 million visits made to office-based
disease. The subcommittee partnered with the Agency physicians in the United States for otitis media, with
for Healthcare Research and Quality and the Southern 809 antibacterial prescriptions per 1000 visits, for a
California Evidence-Based Practice Center to develop a total of more than 20 million prescriptions for otitis
comprehensive review of the evidence-based literature media–related antibacterials. Although the total
related to AOM. The resulting evidence report and other number of office visits for otitis media decreased to
sources of data were used to formulate the practice guide- 16 million in 2000, the rate of antibacterial prescrib-
line recommendations. The focus of this practice guide-
line is the appropriate diagnosis and initial treatment of ing was approximately the same (802 antibacterial
a child presenting with AOM. prescriptions per 1000 visits for a total of more than
The guideline provides a specific definition of AOM. 13 million prescriptions).2–4 An individual course of
It addresses pain management, initial observation versus antibacterial therapy can range in cost from $10 to
antibacterial treatment, appropriate choices of antibacte- more than $100.
rials, and preventive measures. Decisions were made There has been much discussion recently as to the
based on a systematic grading of the quality of evidence necessity for the use of antibacterial agents at the
and strength of recommendations, as well as expert con- time of diagnosis in children with uncomplicated
sensus when definitive data were not available. The prac- AOM. Although in the United States the use of an-
tice guideline underwent comprehensive peer review be-
fore formal approval by the partnering organizations.
tibacterial agents in the management of AOM has
This clinical practice guideline is not intended as a sole been routine, in some countries in Europe it is com-
source of guidance in the management of children with mon practice to treat the symptoms of AOM initially
AOM. Rather, it is intended to assist primary care clini- and only institute antibacterial therapy if clinical im-
cians by providing a framework for clinical decision- provement does not occur. For the clinician, the
making. It is not intended to replace clinical judgment or choice of a specific antibacterial agent has become a
establish a protocol for all children with this condition. key aspect of management. Concerns about the ris-
These recommendations may not provide the only appro- ing rates of antibacterial resistance and the growing
priate approach to the management of this problem. costs of antibacterial prescriptions have focused the
attention of the medical community and the general
ABBREVIATIONS. AOM, acute otitis media; OME, otitis media public on the need for judicious use of antibacterial
with effusion; AAP, American Academy of Pediatrics; AAFP, agents. Greater resistance among many of the patho-
American Academy of Family Physicians; AHRQ, Agency for
Healthcare Research and Quality; MEE, middle-ear effusion;
gens that cause AOM has fueled an increase in the
CAM, complementary and alternative medicine. use of broader-spectrum and generally more expen-
sive antibacterial agents.
It is the intent of this guideline to evaluate the
A
cute otitis media (AOM) is the most common published evidence on the natural history and man-
infection for which antibacterial agents are agement of uncomplicated AOM and to make rec-
prescribed for children in the United States. ommendations based on that evidence to primary
As such, the diagnosis and management of AOM has care clinicians including pediatricians, family physi-
cians, physician assistants, nurse practitioners, and
emergency department physicians as well as otolar-
The recommendations in this guideline do not indicate an exclusive course yngologists. The scope of the guideline is the diag-
of treatment or serve as a standard of medical care. Variations, taking into
account individual circumstances, may be appropriate.
nosis and management of uncomplicated AOM in
PEDIATRICS (ISSN 0031 4005). Copyright © 2004 by the American Acad- children from 2 months through 12 years of age
emy of Pediatrics. without signs or symptoms of systemic illness unre-
cure at follow-up.69 Another way to measure the age: 30%) of upper respiratory tract isolates of S
outcome of treatment of AOM with various antibac- pneumoniae are also not susceptible to penicillin;
terial agents is to assess bacteriologic efficacy. Al- approximately 50% of these are highly resistant
though this does not provide a one-to-one correlation to penicillin (minimum inhibitory concentration: 2.0
with clinical effectiveness, there is a definite concor- g/mL or higher), and the remaining 50% are inter-
dance between the two.77–79 Children who experi- mediate in resistance (minimum inhibitory concen-
ence a bacteriologic cure improve more rapidly and tration: between 0.1 and 1.0 g/mL).88–91 The mech-
more often than children who experience bacterio- anism of penicillin resistance among isolates of S
logic failure. Carlin et al79 showed an 86% agreement pneumoniae is not associated with -lactamase pro-
between clinical and bacteriologic response. Dagan duction but rather an alteration of penicillin-binding
et al77 showed that 91% of clinical failures at or proteins. This phenomenon, which varies consider-
before day 10 were culture-positive at days 4 to 5. If ably according to geographic location, results in re-
we use bacteriologic cure as a surrogate for clinical sistance to penicillins and cephalosporins.
efficacy, there is strong evidence that drugs that Data from early studies of patients with AOM
achieve antibacterial concentrations that are able to show that 19% of children with S pneumoniae and
eradicate pathogens from the middle-ear fluid are 48% with H influenzae cultured on initial tympano-
the preferred selection.80,81 centesis who were not treated with antibacterial
Numerous studies have shown that the common agents cleared the bacteria at the time of a second
pathogens in AOM are Streptococcus pneumoniae, tympanocentesis 2 to 7 days later.92 Estimates are
nontypeable H influenzae, and M catarrhalis.82,83 S that approximately 75% of children infected with M
pneumoniae has been recovered from the middle-ear catarrhalis also experience bacteriologic cure, based
fluid of approximately 25% to 50% of children with on resolution after treatment with an antibacterial
AOM, H influenzae from 15% to 30%, and M catarrha- agent to which it is not susceptible (amoxicillin).93,94
lis from approximately 3% to 20%.83 There is some Only S pneumoniae that are highly resistant to peni-
evidence that the microbiology of AOM may be cillin will not respond to conventional doses of
changing as a result of routine use of the heptavalent amoxicillin.95 Accordingly, approximately 80% of
pneumococcal vaccine. Block et al84 showed an in- children with AOM will respond to treatment with
crease in H Influenzae from 39% to 52% of isolates in high-dose amoxicillin, including many caused by re-
children 7 to 24 months of age with AOM and a sistant pneumococci. The higher dose will yield mid-
decrease in S pneumoniae from 49% to 34% between dle-ear fluid levels that exceed the minimum inhibi-
1992–1998 and 2000 –2003. Viruses, including respi- tory concentration of all S pneumoniae that are
ratory syncytial virus, rhinovirus, coronavirus, para- intermediate in resistance to penicillin and many, but
influenza, adenovirus, and enterovirus, have been not all, highly resistant S pneumoniae.76 Risk factors
found in respiratory secretions and/or MEE in 40% for the presence of bacterial species likely to be re-
to 75% of AOM cases and in MEE without bacteria in sistant to amoxicillin include attendance at child
5% to 22% of cases and may be responsible for many care, recent receipt (less than 30 days) of antibacterial
cases of apparent antibacterial agent “failure.” In treatment, and age younger than 2 years.96,97
approximately 16% to 25% of cases of AOM, no If the patient is allergic to amoxicillin and the
bacterial or viral pathogen can be detected in allergic reaction was not a type I hypersensitivity
MEE.19,85,86 reaction (urticaria or anaphylaxis), cefdinir (14
Currently approximately 50% of isolates of H in- mg/kg per day in 1 or 2 doses), cefpodoxime (10
fluenzae and 100% of M catarrhalis derived from the mg/kg per day, once daily), or cefuroxime (30
upper respiratory tract are likely to be -lactamase– mg/kg per day in 2 divided doses) can be used. In
positive nationwide.87 Between 15% and 50% (aver- cases of type I reactions, azithromycin (10 mg/kg per
Recommended Antibacterial Agents for Patients Who Are Being Treated Initially With Antibacterial Agents or Have Failed 48 to 72 Hours of Observation or Initial Management With
Tympanocentesis, clindamycin
months.37(161–162) OME must be differentiated clini-
Non-type I: ceftriaxone, 3
but not antibacterial therapy. Assurance that OME
resolves is particularly important for children with
Allergy
cognitive or developmental delays that may be im-
pacted adversely by transient hearing loss associated
With Antibacterial Agents
with MEE.
RECOMMENDATION 5
Clinicians should encourage the prevention of AOM
through reduction of risk factors. (This recommendation is
based on strong observational studies and a preponderance
Amoxicillin-clavulanate,
90 mg/kg per day of
of benefits over risks.)
component, with 6.4
mg/kg per day of
A number of factors associated with early or re-
Recommended
Ceftriaxone, 3 days
current AOM are not amenable to change, for exam-
ple, genetic predisposition, premature birth, male
clavulanate
amoxicillin
Ceftriaxone, 1 or 3 days
cefpodoxime; type I:
azithromycin,
cefuroxime,
of amoxicillin,
clear.108,109,114,119,120
clavulanate
Ceftriaxone, 1 or 3
I: azithromycin,
Alternative for
cefuroxime,
RECOMMENDATION 6
No recommendations for complementary and alterna-
tive medicine (CAM) for treatment of AOM are made
Antibacterial Agents
Yes
No
ments that have been used for AOM include children if they are using medicines, supplements, or
homeopathy, acupuncture, herbal remedies, chiro- other means to maintain health or treat specific con-
practic treatments, and nutritional supplements.130 ditions;131 however, parents/caregivers are often re-
Many physicians ask parents, caregivers, or older luctant to tell their physicians that they are using
complementary or alternative treatments.132 Al- doses of medication shown to achieve adequate lev-
though most treatments are harmless, some are not. els in the middle ear to treat the target organisms
Some treatments can have a direct and dangerous successfully; and stratify outcomes by age and sever-
effect, whereas others may interfere with the effects ity of illness. In addition, studies done in limited
of conventional treatments.30 Clinicians should be- geographic areas must be replicated in other areas to
come more informed about CAM, ask whether they ensure generalizability.
are being used, and be ready to discuss potential Some of the studies that should be considered
benefits or risks.133 include:
To date there are no studies that conclusively show
a beneficial effect of alternative therapies used for • Additional validation of standard definitions of
AOM. Recent interest in the use of CAM has led to AOM
research efforts to investigate its efficacy.134 It is dif- • New or improved technologies for objective diag-
ficult to design and conduct studies on certain forms nosis of MEE
of CAM because of the unique nature of the treat-
• Efficacy of education programs to improve clini-
ment.135 Any study conducted will need to show
cian diagnostic skills
proof of effectiveness of a specific therapy when
• Additional studies on pain management including
compared with the natural history of AOM. Conclu-
sions regarding CAM cannot be made until research topical agents, CAM, and role of tympanocente-
evidence is available. sis/myringotomy in pain management
• Large population-based studies on the benefits
FUTURE RESEARCH and risks of the “observation option” looking at
Despite the voluminous literature about AOM, antibacterial use; bacterial resistance; incidence of
there still are many opportunities for future research adverse events; long-term effects on hearing; per-
to continue to clarify the accurate diagnosis and most sistence of MEE; and parent, patient, and clinician
effective management of this common condition. satisfaction
Most important is that future studies address con- • Continued development of new antibacterial
cerns regarding the quality and applicability of many agents to address potential changes in resistance
studies in AOM.21,69,78,100 Future studies should use patterns of organisms responsible for AOM (stud-
standardized criteria for diagnosis, outcome, and se- ies on new agents must be appropriately designed
verity of illness; increase sample size, which in gen- and have adequate sample size to show clinical
eral has been too limited to identify small but signif- efficacy equal to or better than current agents)
icant differences in clinical outcome; include children • Randomized, controlled trials on duration of treat-
younger than 2 years and older than 12 years; use ment in all age groups
Updated Information & including high resolution figures, can be found at:
Services http://pediatrics.aappublications.org/content/113/5/1451
References This article cites 124 articles, 26 of which you can access for free at:
http://pediatrics.aappublications.org/content/113/5/1451#BIBL
Subspecialty Collections This article, along with others on similar topics, appears in the
following collection(s):
Current Policy
http://www.aappublications.org/cgi/collection/current_policy
Subcommittee on Management of Acute Otitis Media
http://www.aappublications.org/cgi/collection/subcommittee_on_ma
nagement_of_acute_otitis_media
Ear, Nose & Throat Disorders
http://www.aappublications.org/cgi/collection/ear_nose_-_throat_dis
orders_sub
Otitis Media
http://www.aappublications.org/cgi/collection/otitis_media_sub
Infectious Disease
http://www.aappublications.org/cgi/collection/infectious_diseases_su
b
Permissions & Licensing Information about reproducing this article in parts (figures, tables) or
in its entirety can be found online at:
http://www.aappublications.org/site/misc/Permissions.xhtml
Reprints Information about ordering reprints can be found online:
http://www.aappublications.org/site/misc/reprints.xhtml
The online version of this article, along with updated information and services, is
located on the World Wide Web at:
http://pediatrics.aappublications.org/content/113/5/1451
Pediatrics is the official journal of the American Academy of Pediatrics. A monthly publication, it
has been published continuously since 1948. Pediatrics is owned, published, and trademarked by
the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk Grove Village, Illinois,
60007. Copyright © 2004 by the American Academy of Pediatrics. All rights reserved. Print ISSN:
1073-0397.