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OBJECTIVES
The objectives of the guideline are (1) to emphasize the requisites of diagnosis of acute otitis
media and (2) to describe treatment options.2
LITERATURE SEARCH
The National Guideline Clearinghouse was searched for guidelines in acute otitis media and 5
relevant guidelines were obtained. These are the 1) American Academy of Pediatrics (AAP) and
American Academy of Family Physicians (AAFP) Subcommittee on Management of Acute Otitis
Media Clinical Practice Guideline; 2) Cincinnati Childrens Hospital Medical Center Evidence
Based Clinical Practice Guideline for Medical Management of Acute Otitis Media; 3) University of
Michigan Health System Guidelines for Clinical Care (Otitis Media); 4) Scottish Intercollegiate
Guidelines Network (SIGN) and 5) Institute for Clinical Systems Improvement. The book
Evidence-Based Otitis Media by Rosenfeld and Bluestone was also reviewed. Additional
literature search strategy used MEDLINE, Cochrane Database, National Library of Medicines
PubMed database, Agency for Healthcare Research and Quality (AHRQ) Evidence Report and
Technology Assessment and Clinical Evidence by British Medical Journal were searched using
the keyword otitis media, exploded to include acute otitis media with the subheadings regarding
prevalence, diagnosis, and therapy. The search was limited to articles involving humans and
those published in English in the last fifteen years. The search yielded 4,226 articles (4222
pubmed, 3 cochrane, 1 AHRQ, 2 Clinical Evidence). Thirty-eight (38) abstracts were chosen and
results were further assessed for relevance. Full text articles were obtained when possible. The
chosen articles were divided as follows:
Meta-analysis
5
Randomized controlled trial
3
Non-randomized controlled study
3
Descriptive study
1
Consensus report/ CPG
5
DEFINITION
Acute otitis media (AOM) is clinically defined as an inflammation of the middle ear with rapid
onset of signs and symptoms of less than 3 weeks duration. 3
Stage of complication
This stage marks the spread of the infection to beyond the middle ear.
6.
RISK FACTORS
Host related factors (very young age, presence of allergy, immunodeficiency, presence of
craniofacial abnormalities, genetic predisposition) as well as environmental factors (upper
respiratory infection, daycare attendance, more siblings, tobacco smoke exposure, bottle feeding,
pacifier use and low socioeconomic status) are considered risk factors in the occurrence,
recurrence and persistence of middle ear disease. 8
History of abrupt onset of otalgia/ ear tugging, irritability in an infant/ toddler, otorrhea and fever
are usually non-specific and are also found in patients with upper respiratory tract infection,
without AOM, thus clinical history alone is poorly predictive of AOM especially in younger
children.3
To identify signs and symptoms of middle ear effusion (MEE), confirmation with the use of
pneumatic otoscopy is recommended. Findings on otoscopy include fullness/ bulging of the
tympanic membrane (highest predictive value for the presence of MEE), reduced/ absent mobility
and opacification or cloudiness of the tympanic membrane. When the presence of middle ear
fluid is difficult to determine, the use of tympanometry can be helpful in establishing the diagnosis.
Findings of middle ear fluid in tympanometry show a type B curve*. 9
Signs and symptoms of middle ear inflammation must also be determined during otoscopy and
includes distinct erythema of the tympanic membrane and this must be differentiated from the
pink erythematous flush evoked by crying or high fever.3
A certain diagnosis of AOM meets the three criteria enumerated in the table.
1.
Clinicians may consider the observation option only if the following can be assured: 1)
adequate follow-up and 2)
presence of an adult who will reliably observe the child, recognize signs and symptoms of
severe illness and be able to provide prompt access to medical care if improvement does
not occur. 3
3.
Severe illness is moderate to severe otalgia or fever =>39 C. Non-severe illness is mild
otalgia and fever< 39 C in the past 24 hours. 3
Symptoms and otoscopic findings Stage 2, 3, 4 and 5.
Identified risk factors include early age of onset (less than 6 months), attendance in day
care or crowded living conditions, low income bracket families, previous recent intake of
antibiotics, cleft palate and other craniofacial abnormalities, recurrent airway infection,
history of bottle feeding, exposure to smoking, allergy, family history of recurrent AOM in
sibling or parent. 8
4.
There are numerous medications that are effective for AOM, Amoxicillin is recommended
as a first-line therapy because of its general effectiveness when used in sufficient doses
against susceptible and intermediate resistant pneumococci, as well as its safety, lowcost, acceptable taste, and narrow microbiologic spectrum. 3
The antibiotic resistance of S. pneumoniae and H. influenzae in developed countries
ranges from 30-60%, thus majority of clinical practice guidelines recommend high dose
Amoxicillin (80-90 mkday). Local data shows that the resistance pattern of both these
bacteria ranges from 3-18% and justifies using a lower dose of Amoxicillin as initial
therapy.13
In another study, the Philippines has a resistance of 2.1% for penicillin- intermediate and
0.0% for penicillin-resistant for Streptococus pneumoniae.14
5.
For patients who are allergic to penicillin, and suspected to be infected by penicillin
resistant S pneumoniae, clindamycin (30 mkday TID) can be used. A single dose of
parenteral ceftriaxone (50 mg/kg) has been shown to be effective for patients who cannot
tolerate the oral form of antibiotic treatment. 3
6.
Duration of antibiotic treatment should depend on the age of the patient and
disease severity.
Grade A Recommendation
The optimal duration of therapy for patients with AOM is still controversial. In a Cochrane
review, the summary odds ratio (OR) for treatment outcomes at eight to 19 days in 1,524
children treated with short-acting antibiotics for five days versus eight to 10 days was
1.52, 95% CI: 1.17-1.98, but by 20 to 30 days outcomes between treatment groups
(n=2,115) were comparable (OR=1.22, 95% CI:0.98-1.54). The absolute difference in
treatment failure at 20 to 30 days suggests that at minimum 17 children would need to be
treated with the long course of short-acting antibiotics to avoid one treatment failure.
Similarity in outcomes was observed for up to three months following therapy
(OR=1.16,95% CI=0.9-1.5). Comparable outcomes were shown between treatment with
ceftriaxone or azithromycin, and more than seven days of other antibiotics.
This review suggested that five days of short-acting antibiotic is effective treatment for
uncomplicated ear infections in children. Although, in another CPG, they pointed out that
the results favoring standard 10-day course have been most significant in children
younger than 2 years and suggestive of increased efficacy in those 2 to 5 years of age.
Thus, for younger patients (< 6 years old), and for children with severe disease, a
standard 10-day course is recommended. For children, 6 years of age and older with
mild to moderate disease, a 5-7 day course is appropriate. 3,15,16
7.
If the patient fails to respond to the initial management option within 48-72 hours,
the clinician must reassess the patient to look for possible complications and exclude
other causes of illness.
7.1.
If the patient was initially managed with observation, management options
include initiating antibacterial therapy.
7.2.
Grade C Recommendation
The time course for clinical response should be 48-72 hours. Criteria for response are
the following: 1) defervescence within 48-72 hours, 2) decreased irritability and 3)
sleeping/ eating patterns should begin to normalize. If AOM is confirmed in the patient
initially managed with observation, the clinician should begin antibacterial therapy.
Amoxicillin 40-50 mkday should be the first line of treatment (see recommendations 3 and
4).
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If the patient was initially managed with an antibacterial agent (s), the clinician should
increase the Amoxicillin to 80-90 mkday 17,18,19 or change the antibacterial agent(s).
Second line antibacterial agents that can be considered are summarized in the table
below.
Table 3. Second line antibacterial medications
Drug
Dose
Amoxicillin40-45 mkday in 2 divided
Clavulanate
doses
Cefuroxime
30 mkday in 2 divided doses
Ceftriaxone
50 mg/kg in 1 dose IM
Azithromycin
20 mg/kg OD
Clarithromycin
15 mkday in 2 divided doses
20
One RCT in infants aged 3 months to 1 year found no significant difference in resolution
of clinical symptoms between groups receiving myringotomy only, antibiotic only, and
myringotomy plus antibiotic, but found higher rates of persistent infection with
myringotomy only. A second RCT in children aged 212 years found no significant
difference between myringotomy and no treatment in reduction of pain at 24 hours or 7
days. A third RCT in children aged 7 months to 12 years found higher rates of initial
treatment failure (resolution of symptoms within 12 hours) for severe episodes of acute
otitis media treated by myringotomy and placebo compared with antibiotic. 21 These
studies do not find added benefit of myringotomy. However, myringotomy can be used to
obtain microbiological sample to guide the physician on antimicrobial therapy.
11
Grade A Recommendation
However, the panel recognizes that these agents maybe used for concomitant illness
such as allergies.
Yes
ACUTE OTITIS
MEDIA
Is pain
present?
N
Recommend pain
relievers
With
complications?
Risk factors?
Y
Treatment Options
1. Start antibiotic
therapy.
2. (+/-) myringotomy
with culture studies
Follow-up
assured
Competent
caregiver
Observe
N
N
Start Amoxicillin 40-50
mkday
Y
Good response
with antibiotics
CONTINUE
MANAGEMENT
12
Treatment Options
1. Amoxicillin 80-90 mkday
2. Change Antibiotics
3. Myringotomy
References
1. World Health Organization definition for pediatric age.
2. Clinical Practice Guidelines 2003. Department of Otorhinolaryngology, Philippine General
Hospital.
3. American Academy of Pediatrics and American Academy of Family Physicians treatment
guidelines for uncomplicated acute otitis media. Pediatrics. 2004.
4. Caparas, Mariano MD.Basics of Otolaryngology.
5. World Health Organization. World Development Report 1993: investing in health
1993;Oxford University Press.
6. Berman S. Otitis media in developing countries. Pediatrics 1995;96:1 Pt 1:126-31
7. ORL-OPD Midyear Census Report 2005. Department of Otorhinolaryngology, Philippine
General Hospital
8. Rosenfeld RM and Bluestone CD. Evidence-Based Otitis Media. Hamilton: B.C.Decker
Inc. 1999.
9. Clinical Practice Guidelines 1997. Philippine Society of Otolaryngology.
10. Bertin L. Pons G, dAthis P et al. a randomized, double blind, multicentre controlled trial of
Ibuprofen versus acetaminophen and placebo for symptoms of acute otitis media in
children. Fundam Clin Pharmacol. 1996; 10:387-92.
11. Goldman RD, Ko K, Linett LJ, Scolnik D. Antipyretic Efficacy and Safety of Ibuprofen and
Acetaminophen in Children. Ann Phramacother 2004; 38:P 146-50.
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12. Li SF, Lacher B, Crain EF.Acetaminophen and ibuprofen dosing by parents. Pediatr
Emerg Care. 2000 Dec;16(6):394-.
13. Carlos, Celia Antimicrobial Resistance Surveillance Data 1998 to 2002. DOH Committee
on Antimicrobial Resistance Surveillance
14. Lee et al. Clin Infect Dis 2001; 32:14631469
15. Kozyrskyj, AL; Hildes-Ripstein, GE; Longstaffe, SEA; Wincott, JL; Sitar, DS; Klassen, TP;
Moffatt, MEK. Short course antibiotics for acute otitis media [Review]. The Cochrane
Database of Systematic Reviews. The Cochrane Library, Copyright 2005, The Cochrane
Collaboration, Volume (2); 2005
16. Cohen, R. Levy C. Boucherat M., Langue, J, de La Roque, F. A multicenter, randomized,
double blind trial of 5 versus 10 days of antibiotic therapy for acute otitis media in young
children. J Pediatr 1998 5;634-639.
17. Bottenfeld G, Burch D, Hedrick J, Schaten R, Rowinski, C, Davies, J. Safety and
Tolerability of a new formulation (90 mkday divided every 12h) of amoxicillin/ clavulanate
in the empiric treatment of pediatric acute otitis media caused by drug-resistant
Streptococcus pneumoniae. Pediatr Infect Dis J, 1998 17(10);963-968.
18. Piglansky L, Leibovitz E, Raiz S, Greenberg D, Press J, Leiberman A, Dagan R.
Bacteriologic And Clinical Efficacy Of High Dose Amoxicillin For Therapy Of Acute Otitis
Media In Children. Pediatr Infect Dis J, 2003;22:40512 Vol. 22, No. 5.
19. Dowell, SF. Acute Otitis Media: management and surveillance in an era of pneumococcal
resistance- a report from the Drug resistant Streptococcus pneumoniae Therapeutic
Working Group. Pediatr Clin North Am; 18:1.
20. Cincinnati Childrens Hospital Medical Center Evidence Based Clinical Practice Guideline
for Medical Management of Acute Otitis Media. October 29, 2004
21. Clinical Evidence. British Medical Journal
22. Flynn CA, Griffin GH, Schultz, JK. Decongestants and antihistamines for acute otitis
media in children. The Cochrane Database of Systematic Reviews. The Cochrane
Library. 2005
Guidelines Reviewed
1. Institute for Clinical Systems Improvement (ICSI). Diagnosis and Treatment of Otitis
Media in Children. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI);
2004 May. 27 p. [58 references]
2. Scottish Intercollegiate Guidelines Network. Diagnosis and Management of Childhood
Otitis Media in Primary Care, A National Clinical Guideline. 2003
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3. Cincinnati Childrens Hospital Medical Center Evidence Based Clinical Practice Guideline
for Medical Management of Acute Otitis Media. October 29, 2004
4. University of Michigan Health System Guidelines for Clinical Care of Otitis Media. May
2002
Search Engines/Database
1. National Guidelines Clearinghouse: http:/www.guideline.gov/
2. Agency for Healthcare Research and Quality: http:/www.ahrq.gov/
Pubmed: http:/www.ncbi.nlm.nih.gov/entrez/query.fcgi
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