Acute otitis media (AOM) is a common disease of childhood. AOM is most appropriately diagnosed by careful otoscopy with an understanding of clinical signs and symptoms. The distinction between AOM and chronic otitis media with effusion should be emphasized. Treatment should include pain management, and initial antibiotic treatment should be given to those most likely to benefit, including young children, children with severe symptoms, and those with otorrhea and/or bilateral AOM. Tympanostomy tube placement may be helpful for those who experience frequent episodes of AOM or fail medical therapy. Recent practice guidelines may assist the clinician with such decisions.
Key points
- •
Acute otitis media (AOM) should be distinguished from chronic otitis media with effusion.
- •
Clinical practice guidelines have been updated to refine the “observation” option for treatment of AOM, with an emphasis on precise diagnosis.
- •
The bacteriology of AOM has been changed by the use of pneumococcal vaccines, but high dose amoxicillin or amoxicillin–clavulanate are good choices when initial antibiotic therapy is prescribed for AOM.
- •
Tympanostomy tubes are an option for children with recurrent AOM, particularly when there is evidence of ongoing Eustachian tube dysfunction.
- •
Complications of AOM are rare, but must be detected early to avoid serious morbidity.
Introduction and definitions
Acute otitis media (AOM) is a common disorder of early childhood, and among the most common reasons for referral of a young child to the otolaryngologist. Although the majority of children with AOM are managed by primary care providers without the need for specialty consultation, children with recurrent episodes, severe symptoms, or complications of AOM can require prompt otolaryngologic evaluation and surgical treatment. Although AOM affects many children, and tympanostomy tube placement is the most commonly performed operative procedure in young children, consensus is still being reached about the most appropriate use of surgery for children with AOM.
We review the relevant concepts in the management of AOM in children, with an emphasis on changes in microbiology over the last 2 decades. We also discuss management paradigms for AOM advanced by evidence-based clinical practice guidelines published in 2013. Surprisingly, these guidelines are the first to recommend tympanostomy tube placement as an option for children with recurrent AOM, despite decades of tympanostomy tube placement for this indication. New emphasis is placed on accurate diagnosis based on strict criteria, with additional refinement of the selection of children most appropriate for observation without antibiotics at initial diagnosis of AOM. This review focuses on AOM and recurrent AOM, and we do not directly discuss management of middle ear effusion (MEE) that is asymptomatic other than hearing loss (otitis media with effusion [OME]). It is important to distinguish AOM from OME, which are separate entities with unique management considerations ( Table 1 ).
| Term | Definition |
|---|---|
| Acute otitis media (AOM) |
|
| Recurrent acute otitis media (RAOM) | Three or more well-documented and separate AOM episodes in the past 6 mo, or ≥4 well-documented and separate AOM episodes in the past 12 mo with ≥1 in the past 6 mo |
| Otitis media with effusion (OME) | The presence of fluid in the middle ear without signs or symptoms of acute ear infection (AOM) |
| Chronic otitis media with effusion (COME) | OME persisting for ≥3 mo from the date of onset (if known) or from the date of diagnosis (if onset unknown) |
Introduction and definitions
Acute otitis media (AOM) is a common disorder of early childhood, and among the most common reasons for referral of a young child to the otolaryngologist. Although the majority of children with AOM are managed by primary care providers without the need for specialty consultation, children with recurrent episodes, severe symptoms, or complications of AOM can require prompt otolaryngologic evaluation and surgical treatment. Although AOM affects many children, and tympanostomy tube placement is the most commonly performed operative procedure in young children, consensus is still being reached about the most appropriate use of surgery for children with AOM.
We review the relevant concepts in the management of AOM in children, with an emphasis on changes in microbiology over the last 2 decades. We also discuss management paradigms for AOM advanced by evidence-based clinical practice guidelines published in 2013. Surprisingly, these guidelines are the first to recommend tympanostomy tube placement as an option for children with recurrent AOM, despite decades of tympanostomy tube placement for this indication. New emphasis is placed on accurate diagnosis based on strict criteria, with additional refinement of the selection of children most appropriate for observation without antibiotics at initial diagnosis of AOM. This review focuses on AOM and recurrent AOM, and we do not directly discuss management of middle ear effusion (MEE) that is asymptomatic other than hearing loss (otitis media with effusion [OME]). It is important to distinguish AOM from OME, which are separate entities with unique management considerations ( Table 1 ).
| Term | Definition |
|---|---|
| Acute otitis media (AOM) |
|
| Recurrent acute otitis media (RAOM) | Three or more well-documented and separate AOM episodes in the past 6 mo, or ≥4 well-documented and separate AOM episodes in the past 12 mo with ≥1 in the past 6 mo |
| Otitis media with effusion (OME) | The presence of fluid in the middle ear without signs or symptoms of acute ear infection (AOM) |
| Chronic otitis media with effusion (COME) | OME persisting for ≥3 mo from the date of onset (if known) or from the date of diagnosis (if onset unknown) |
Epidemiology
AOM is a common disease in children. In the United States, 8.8 million children (11.8%) under the age of 18 were reported to have ear infections in 2006, with an estimated total treatment cost of $2.8 billion. Antibiotics are prescribed for AOM more frequently than for any other illness of childhood. The epidemiology of AOM has evolved over the past decade, with a decrease in clinician visits for suspected AOM by 33% from 1995–1996 to 2005–2006. The reasons for the decrease in clinician visits is unclear, with possible explanations including financial considerations, health care access issues, public educational campaigns about the viral etiology of most upper respiratory tract infections, the introduction of the 7-valent pneumococcal vaccine (PCV7) and influenza vaccines, and publication and implementation of clinical practice guidelines.
Interestingly, clinician prescribing patterns have not changed significantly for children with AOM, with the rate of antibiotic prescription per visit remaining approximately stable (80% in 1995–1996 to 76% in 2005–2006). More recent study of prescribing patterns for AOM shows treatment strategy may vary among medical disciplines, with 1 report showing a drop in early antibiotic use for AOM by pediatricians and otolaryngologists between 2002 and 2009, but an increase in antibiotic use by family practitioners over the same period. However, with now almost 10 years since the advancement of the concept that prompt antibiotic treatment is not needed for many children with AOM, observation of selected children with a diagnosis of AOM without initial antibiotics has become more accepted by both caregivers and providers. Additionally, physician adherence to the treatment recommendations from clinical practice guidelines may be improved with performance feedback and decision support systems using electronic health records.
Pathophysiology and microbiology
AOM is often, although not always, preceded by a viral upper respiratory tract infection. Inflammation leads to edema in the nasal cavities and nasopharynx, causing functional obstruction of the Eustachian tube and the development of negative pressure in the middle ear from a lack of equilibration. Microbe-containing secretions from the upper airway mucosa move into the middle ear owing to the pressure differential, where they become trapped. Bacterial replication and infection may ensue. Young children are at particularly increased risk for AOM because of increased viral exposure, immunologic naiveté, and impaired Eustachian tube function even at baseline.
With sensitive assays including culture, polymerase chain reaction and antigen detection, bacteria, viruses, or both, are detected in middle ear fluid in up to 96% of AOM cases. A study of middle ear fluid in 79 children with AOM and indwelling tympanostomy tubes found that 66% had bacteria and viruses, 27% had bacteria alone, and 4% had only viruses.
The microbiology of AOM has changed over the last 2 decades with increasing penetration of pneumococcal vaccination programs. The most common bacterial species that cause AOM continue to be Streptococcus pneumoniae , nontypeable Haemophilus influenza , and Moraxella catarrhalis . The heptavalent S pneumoniae vaccine (PCV7) was introduced in 2000, shortly after which the frequency of S pneumoniae recovery in tympanocentesis studies of AOM decreased relative to that of the other microbes. The S pneumoniae serotypes contained in PCV7 continued to decline in AOM patients, and were in fact nearly absent by 2007 through 2009. However, they have been replaced by nonvaccine pneumococcal serotypes in both tympanocentesis and nasopharyngeal colonization studies, so that the incidence of S pneumoniae was approximately equal to that of H influenza , with M catarrhalis less frequent. The new 13-valent S pneumoniae vaccine, PCV13, was licensed in 2010 and will undoubtedly additionally shift the microbiological landscape of AOM.
Diagnosis
Because there is no gold standard for the diagnosis of AOM, short of tympanocentesis and culture of middle ear fluid, there is controversy about the best clinical means to accurately diagnose acute middle ear infection. Diagnostic accuracy is challenging because of the wide spectrum of signs and symptoms that develop throughout the course of the disease, the difficulties in examining the ears of young children who may be uncooperative or have occluding cerumen, and the overlap of symptoms (fever, otalgia, irritability, insomnia) with other entities such as viral illness. In one study of 469 patients ages 6 to 35 months who were suspected by their caregivers to have AOM, only 237 (50%) actually met strict defined criteria for this diagnosis. Additionally, the distinction between AOM and chronic OME is unclear to many caregivers and even to many medical professionals.
The diagnostic accuracy for children with AOM is important when we strategize for treatment of children with AOM. Children with upper respiratory infections and chronic OME generally should not be treated with antibiotics. Many children with AOM do not require antibiotics for cure because the natural history of AOM is in general favorable. When we interpret studies of treatment of AOM with antibiotics compared with placebo, those studies that include children with AOM diagnosed less stringently are more likely to include children with respiratory tract infections and OME rather than AOM. Treatment differences may be affected (made smaller) by use of less stringent diagnostic criteria. However, the “real-world” diagnosis of AOM in young children is unfortunately often far from precise, and the conclusions of those studies may be quite applicable to a cohort of children with presumed AOM.
The 2013 American Academy of Pediatrics (AAP) guideline on the management of AOM emphasized diagnostic criteria that focused on otoscopic examination ( Table 2 ). This guideline proposed that AOM should be diagnosed in children with moderate to severe bulging of the tympanic membrane (TM) or new onset of otorrhea, or in children with mild bulging of the TM with recent onset of ear pain or intense TM erythema. In addition, AOM should not be diagnosed in children without a MEE. This represents a new emphasis on precise diagnosis compared with the 2004 guidelines, which did not require a bulging TM and made management suggestions when there was an “uncertain diagnosis.”
| Subject | 2004 | 2013 | Rationale for 2013 Changes |
|---|---|---|---|
| Children <6 mo | Treat with antibiotic therapy | No recommendations | |
| Diagnosis of AOM | Acute onset of signs and symptoms Presence of MEE Signs and symptoms of middle ear inflammation a | Moderate to severe bulging of TM, or new-onset otorrhea not owing to acute otitis externa Mild bulging of TM and recent b onset ear pain c or intense TM erythema Must have MEE | 2004 criteria allowed less precise diagnosis, provided treatment recommendation when diagnosis was uncertain. |
| Uncertain diagnosis | Expected and included in treatment guidelines | Excluded | Emphasized need for diagnosis of AOM for best management. |
| Initial observation option instead of initial antibiotic therapy |
| Favorable natural history overall. Evidence of small benefit of antibiotics in recent trials that used stringent diagnostic criteria. | |
| Initial antibiotic therapy recommended | More stringent diagnostic guidelines in 2013 should lead to greater antibiotic benefit. Greater antibiotic benefit for bilateral disease, AOM with otorrhea. Two recent studies show small benefit of antibiotics for age 6–24 mo. | ||
| Recurrent AOM | No recommendations | Do not prescribe prophylactic antibiotics May offer tympanostomy tubes | Minimal benefit for prophylaxis and antibiotics come with risks (antibiotic resistance and adverse effects). Modest reduction in AOM with tubes. |
a Signs and symptoms of middle ear inflammation include distinct erythema of TM or distinct otalgia (‘discomfort clearly referable to the ear[s] that results in interference with or precludes normal activity or sleep’).
c Ear pain may be indicated by holding, tugging, or rubbing of the ear in a nonverbal child.
d Nonsevere illness defined as mild otalgia and fever <39°C in the past 24 hours in the 2004 guideline; the 2013 guideline modifies this to “mild otalgia for less than 48 hours and temperature less than 39°C.”
e Severe signs or symptoms include moderate or severe otalgia or temperature ≥39°C in 2004 guideline; the 2013 guideline also includes otalgia for ≥48 hours.
Such strict diagnostic criteria were used in 2 randomized, controlled trials of antibiotics for AOM, both of which found benefit of antibiotic compared with placebo. In prior studies, antibiotic therapy resulted in clinical improvement in approximately 6% to 12% of children with AOM. In these 2 recent trials the rate of clinical improvement was 26% to 35%, likely owing to accurate diagnosis of AOM on entry as well as the nature of the measures of clinical improvement.
Hoberman and colleagues randomized 291 patients 6 to 23 months old with AOM to receive either amoxicillin–clavulanate or placebo for 10 days and recorded symptomatic response with the Acute Otitis Media Severity of Symptoms scale, as well as treatment failure. Diagnostic criteria included (1) onset of symptoms within 48 hours with score of 3+ on the Acute Otitis Media Severity of Symptoms scale, (2) MEE, and (3) moderate or marked bulging of TM, or slight bulging with either otalgia or marked erythema of TM. The treatment group had a lower Acute Otitis Media Severity of Symptoms scale score at 7 days ( P = .04), with a lower treatment failure rate at days 4 or 5 and 10 through 12 (4% vs 24% [ P <.001] and 16% vs 51% [ P <.001], respectively). Tahtinen and colleagues randomized 319 patients 6 to 35 months old with AOM to receive either amoxicillin–clavulanate or placebo for 7 days and measured time to treatment failure. Diagnostic criteria were (1) MEE, (2) signs of acute inflammation in TM, and (3) acute symptoms such as fever, ear pain, or respiratory symptoms. Treatment failure occurred in 18.6% of the treatment group, which was significantly lower than the 44.0% treatment failure rate for the placebo group ( P <.001).
We should consider that these studies used amoxicillin–clavulanate rather than amoxicillin in the treatment arms. We should also consider that the treatment benefits of antibiotics over placebo were small, with debate about the clinical significance of some outcome measures in these studies. Of course, small benefits of antibiotics must be assessed in light of side effects, most commonly diarrhea or yeast infections, as well as concerns about antibiotic overuse and bacterial resistance.
Otoscopy
Note that the “red eardrum,” or the ear “with fluid,” is not diagnostic for AOM in the absence of bulging or otorrhea, according to the 2013 AAP guideline. MEE is necessary but alone not sufficient for the diagnosis of AOM, because OME is distinct from AOM (see Table 1 ). Although OME may precede or follow an episode of AOM, it is not an acute infectious process and in general should not be treated with antibiotics. The appearance of the TM evolves over the course of the disease, and a change in clinical status warrants repeat examination.
In addition to examination of the color, position, and contour of the TM, pneumatic otoscopy to assess TM mobility is an important component of otoscopy. Absent or reduced TM mobility are diagnostic features of a MEE, as is an air–fluid level behind the TM. Tympanometry, when available, can also provide more quantitative information about TM mobility and middle ear compliance.
Otoscopy can be challenging in children. Uncooperative patients, cerumen impaction, inadequate instrumentation, and even lack of expertise are common difficulties. Despite these challenges, the 2013 guideline underscores the importance of a thorough physical examination in the management of AOM, and reinforces the need for training pediatric clinicians in otoscopic and pneumatic otoscopic skills. Suggestions for cerumen removal can be found in the American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) Clinical Practice guidelines on cerumen impaction. Diagnostic difficulties may lead to referral to an otolaryngologist for cerumen removal and examination of the ears with the otomicroscope ( Box 1 ).
Referral to an otolaryngologist should be considered for the following reasons:
Inability to examine the ear
Unexplained, progressive, or irreversible tympanic membrane abnormality
Poor response to therapy
Recurrent AOM
Associated hearing difficulties that persist or progress
Recurrent AOM in the “at-risk child”
Suspected complication of AOM
Management
Management goals for AOM are to decrease severity and duration of symptoms, principally by controlling pain and fever, to improve hearing outcomes, and to prevent complications.
Analgesia
The assessment and treatment of pain is an important but possibly overlooked component of pediatric care. Poorly controlled pain is associated with suffering and can be emotionally traumatic, causing anxiety for patients and their caregivers. Pain control should be actively addressed whether initial treatment included immediate antibiotics or not, because the antibiotics may not begin to provide pain relief for more than 24 hours. Although there are many options for treatment of otalgia, including oral, topical, and homeopathic agents, few have been well studied.
Oral acetaminophen and ibuprofen are commonly used to treat pain in children with AOM. A randomized, blinded, placebo-controlled trial found that both ibuprofen and acetaminophen improved pain control over placebo, but only ibuprofen resulted in a significant increase over placebo, with continued pain in 7%, 10%, and 24% of patients receiving ibuprofen, acetaminophen, and placebo, respectively ( P <.01 for ibuprofen). Topical drops, both anesthetic and naturopathic, have been found in small trials to improve pain symptoms, but a Cochrane review concluded that there is insufficient evidence to make any statement about their efficacy. The selection of pain medication, as well as the dosing and schedule for administration, should be discussed with the caregivers, who may have valuable experience and preferences.
Antibiotic Therapy
Antibiotic therapy is intended to target the bacteria present in the MEE of children with AOM. Two key decisions regarding antibiotic use occur with every diagnosis of AOM: (1) Should antibiotics be used immediately, and (2) if antibiotics are used, which antibiotic is the best choice for treatment?
The decision of whether or not to treat with initial antibiotics is based on age, severity of symptoms, the presence of otorrhea, and laterality ( Box 2 , see Table 2 ). In the 2013 AAP guideline, antibiotics are recommended for any child with otorrhea, or severe symptoms, or both, and for children younger than 2 years with bilateral AOM. There is an option for initial observation instead of initial antibiotics if children are younger than 2 years old with unilateral disease and no otorrhea, or 2 years or older with either bilateral or unilateral disease and no otorrhea (see Table 2 ).
The decision to treat AOM with antibiotics at time of diagnosis or to observe with close follow-up should include:
Parental/caregiver input and informed shared decision making
Ability to follow patients for improvement or deterioration
Understanding that young children (<6 months of age), children with bilateral AOM, and children with otorrhea should be treated with antibiotics
Understanding that children with severe symptoms (moderate or severe otalgia or otalgia for at least 48 hours, or temperature 39°C [102.2°F] or higher) should be treated with antibiotics
Understanding the controversies about the need to use antibiotics in children between 6 and 24 months who have AOM with mild or moderate symptoms.
The concept of initial observation, without immediate antibiotic treatment, of children diagnosed with AOM was advanced in Europe before the 2004 recommendations of the AAP did so here in the United States. The favorable natural history of AOM, the potential overdiagnosis of AOM, and the potential consequences of antibiotics, including frequent side effects and the emergence of drug resistant microbes, are all considerations here.
A recent Cochrane review found that up to 82% of children with AOM improve spontaneously. Although there is a slight improvement in symptoms associated with antibiotics (relative risk [RR], 0.70; 95% CI, 0.57–0.86 and RR, 0.79; 95% CI 0.66–0.95 for 2–3 days and 4–7 days, respectively), 20 children would need to receive antibiotics to prevent 1 child from experiencing ear pain at 2 to 7 days. Antibiotics did significantly reduce TM perforations and contralateral AOM episodes; however, there was no effect on tympanometry findings at 4 weeks to 3 months, or on the number of AOM recurrences. Antibiotics also increased the relative risk of adverse events by 34% (95% CI, 16%–55%), most commonly vomiting, diarrhea, and rash.
The decision to observe without immediate antibiotics should be made in conjunction with caregivers, with a plan for pain management at the outset and a mechanism for follow-up within 48 to 72 hours so antibiotics can be started for persistent or worsening symptoms. There is evidence that in the proper setting this strategy does not increase complication rates. Clinicians may also give caregivers an antibiotic prescription with instructions to have it filled only under certain circumstances, the so-called wait-and-see prescription (WASP). This approach seems to avoid antibiotic use in up to two thirds of children selected for observation.
Antibiotic Choice
If antibiotic treatment is used for a child with AOM, the choice of antibiotic is based on the most common pathogens and their susceptibility patterns as well as the side effect profile of the drug. High-dose amoxicillin (90 mg/kg per day) is the recommended first-line agent in the 2013 guidelines, with the addition of beta-lactamase coverage for cases in which the patient has recently received amoxicillin, has concurrent purulent conjunctivitis, or has recurrent AOM unresponsive to amoxicillin. S pneumoniae is 83 to 87% susceptible to high-dose amoxicillin, and H influenza is 58% to 82% susceptible. Interestingly, more than 90% of M catarrhalis is beta-lactamase positive, but a high rate of spontaneous clinical improvement and low rate of suppurative complications with AOM from this organism makes amoxicillin treatment an appropriate first choice.
For penicillin-sensitive patients, second- or third-generation cephalosporins, including intramuscular ceftriaxone, may be used. Other useful agents, particularly for penicillin-sensitive patients or amoxicillin failures, include second- and third-generation cephalosporins and clindamycin. Patients who do not improve in 48 to 72 hours on their first-line regimen should be reassessed, and alternative therapy considered. In this instance, amoxicillin–clavulanate and intramuscular or intravenous ceftriaxone are considered first line, with alternatives including clindamycin or combination treatment with both clindamycin and a third-generation cephalosporin. In difficult cases, tympanocentesis may be considered for drainage and culture-directed therapy.
Stay updated, free articles. Join our Telegram channel
Full access? Get Clinical Tree
