ACUTE OTITIS MEDIA IN CHILDREN

SCOPE OF THE PRACTICE GUIDELINE

This clinical practice guideline is for use by the Philippine Society of Otolaryngology-Head and
Neck Surgery. It covers the diagnosis and management of acute otitis media in children 2
months to less than 20 years of age. 1,2

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 Children’s 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 Medicine’s
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

NATURAL HISTORY OF ACUTE OTITIS MEDIA

The group recognizes that acute otitis media may progress through the following stages. These
stages are: 4
1. Stage of hyperemia/ retraction
This is the onset of disease with generalized hyperemia of the mucoperiosteum.
Symptoms include mild earache, ear fullness and fever. Otoscopy will show an erythematous
and markedly retracted eardrum.

2. Stage of exudation
This stage marks the outpouring of fluid from the dilated permeable capillaries. All
symptoms are aggravated especially pain and fever. Otoscopy will reveal a red, thickened
bulging eardrum with loss of the light reflex.

3. Stage of suppuration / perforation

The eardrum ruptures and there will be a lot of discharge from the middle ear. Fever and
pain are now relieved but hearing loss worsens.
 4. Stage of coalescence and surgical mastoiditis
In this stage, there is a recurrence of the pain, mastoid tenderness and fever but to a
milder degree. Examination at this stage will reveal mastoid tenderness and sagging of the
posterosuperior wall.

5. Stage of complication
This stage marks the spread of the infection to beyond the middle ear.

6. Stage of resolution
This may occur at any stage of the disease.

PREVALENCE AND EPIDEMIOLOGY

In developing countries, the World Health Organization (WHO) attributes 51,000 deaths per year,
in children under five years old, to otitis media. In terms of disability adjusted life years, otitis
media is comparable to meningitis, polio and trachoma. 5 The etiology of AOM is similar in
developed and developing countries. However, complication rates (with up to 20% progressing to
chronic serous otitis media or mastoiditis) in developing countries are similar to those in Europe
and the USA in the 1930s and 1940s, and the pre-antibiotic era. 6
In PGH, acute otitis media constitutes 0.9% of ENT-OPD consults. 7

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

RECOMMENDATIONS ON THE DIAGNOSIS OF ACUTE OTITIS MEDIA

1. To diagnose acute otitis media, the physician should confirm a history of acute onset
and evaluate for the signs and symptoms of middle ear inflammation.

Grade B Recommendation

Table 1. Definition of Acute Otitis Media 3

A diagnosis of acute otitis media requires 1) a history of acute onset of signs and
symptoms, AND 2) signs and symptoms of middle ear inflammation.

Elements of the definition of acute otitis media are:

1. recent (within a time frame of less than three weeks), usually abrupt onset of signs and
symptoms of middle ear inflammation.
AND
2. any one of the following otoscopic findings:
a. markedly retracted tympanic membrane
b. distinct erythema of the tympanic membrane
c. bulging of the tympanic membrane
d. limited or absent mobility of the tympanic membrane
e. air-fluid level or air bubbles behind the tympanic membrane
f. perforation with otorrhea

AND
3. any one of the following:
a. fever
b. distinct otalgia (discomfort clearly referable to the ear(s) that results in
interference with or precludes normal activity or sleep)
 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, 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.

RECOMMENDATIONS ON THE TREATMENT OF ACUTE OTITIS MEDIA

1. The effective management of acute otitis media includes an assessment of otalgia

and relief of otalgia should be addressed by any of the recommended treatments.

Grade B Recommendation

The management of pain especially during the first 24 hours of an episode of AOM,
should be addressed, regardless of the use of antibacterial agents. The use of
Paracetamol (10-15 mkdose) or Ibuprofen ( 5-10 mkdose ) provides effective analgesia
for mild to moderate pain, is readily available and is a mainstay of pain management for
acute otitis media.10,11,12

In young children pain is a symptom that compels mothers to bring children to

doctors. It is also a gauge of clinical effectiveness.3

2. Observation alone in a child with uncomplicated AOM is an option for selected

children based on illness severity and assurance of follow-up.

Grade C Recommendation

Uncomplicated acute otitis media is defined as inflammation confined to the middle

ear cleft with absence of the following: 1) severe otalgia and serious illness 2)
unsatisfactory response to initial optimal antibacterial therapy 3) associated with a
confirmed or potential suppurative complication 4) immunologically deficient patient any
of whom may harbor an unusual organism. 8

The “observation option” for AOM refers to deferring antibacterial treatment or

myringotomy of selected children for 48 to 72 hours and limiting management to
symptomatic relief. The decision to observe or treat is based on illness severity. To
observe a child without initial antibiotic therapy, it is important that the parent or caregiver
has a ready means of communicating with the clinician. There must also be a system in
place that permits reevaluation of the child. If necessary, the parent or caregiver must
also be able to conveniently obtain medication. 3
 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. Antibiotic therapy may be initiated in patients with uncomplicated acute otitis

media based on severity of illness, as defined by symptoms, otoscopic findings
and presence of risk factors.

Grade B recommendation

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
4
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. If a decision is made to treat with an antibacterial agent, the clinician should

initially prescribe Amoxicillin 40-50 mkday for children with uncomplicated AOM.

Grade A Recommendation

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, low-cost, 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. If the patient is allergic to Amoxicillin, alternative drugs should be considered.

Grade C Recommendation

Depending on the type of allergic reaction observed, several antibiotics can be

recommended.

Table 2. Alternative Drugs to Amoxicillin for allergic patients. 3

Type I Hypersensitivity Reaction Non-Type I Hypersensitivity Reaction
Azithromycin (10 mkday on Day1, Cefdinir (14 mkday in 1 or 2 doses)
followed by 5 mkday x 4 days OD) Cefpodoxime (10 mkday OD)
Clarithromycin (15 mkday in 2 divided Cefuroxime (30 mkday in 2 divided doses)
doses)
Erythromycin-sulfisoxazole (50 mkday
erythromycin)
Sulfamethoxazole-Trimethoprim (6-10
mkday trimethoprim)
 Type I hypersensitivity is immediate or anaphylactic hypersensitivity. The reaction takes 15-30 minutes from
the time of exposure to the antigen.
Non-Type I hypersensivity is not an immediate reaction and may involve other mechanisms of allergy.

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. If the patient was initially managed with an antibacterial agent (s),
management options include 1) increasing the dose of Amoxicillin to 80-90
mkday; 2) change the antibacterial agent(s); or 3) perform myringotomy in
addition to modified antibacterial therapy

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).

If the patient was initially managed with an antibacterial agent (s), the clinician should
increase the Amoxicillin to 80-90 mkday17,18,19 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 20

Drug Dose Maximum Dose/ Day
Amoxicillin- 40-45 mkday in 2 divided 2 gm
Clavulanate doses
Cefuroxime 30 mkday in 2 divided doses 1 gm
Ceftriaxone 50 mg/kg in 1 dose IM 1 gm
Azithromycin 20 mg/kg OD 250 mg
Clarithromycin 15 mkday in 2 divided doses 1 gm

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 2–12 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.

8. Immediate active intervention is recommended in patients with complicated acute

otitis media.

Grade A Recommendation

Complicated acute otitis media includes patients with 1) severe otalgia and serious
illness 2) unsatisfactory response to initial optimal antibacterial therapy 3) associated with
a confirmed or potential suppurative complication 4) immunologically deficient patient any
of whom may harbor an unusual organism. There is lack of evidence regarding the
management of AOM in this special group of patients and since the benefit of treating
them far outweighs the foreseen harm, the panel recommends immediate treatment.

Immediate active intervention may include any of the following:

a. administration of empiric antibacterial treatment
b. myringotomy with culture and sensitivity studies for appropriate antibacterial
therapy

9. The use of antihistamine/ decongestant therapy is not recommended for treatment

of acute otitis media.

Grade A Recommendation

Antihistamine/decongestant therapy is not recommended for treatment of acute otitis

media in a child of any age, because review of the literature showed that these agents
are not effective for this condition, either separately or together. 22 However, the panel
recognizes that these agents maybe used for concomitant illness such as allergies.
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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, d’Athis 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.

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; 32:1463–1469

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;22:405–12 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 Children’s 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
3. Cincinnati Children’s 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/
3. Pubmed: http:/www.ncbi.nlm.nih.gov/entrez/query.fcgi