An Evidence-Based Approach To Managing Acute Otitis Media
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An Evidence-Based Approach To Managing Acute Otitis Media

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Table of Contents
 
Table of Contents
  1. Abstract
  2. Case Presentation
  3. Introduction
  4. Critical Appraisal Of The Literature
  5. Etiology And Pathophysiology
  6. Differential Diagnosis
  7. Prehospital Care
  8. Emergency Department Evaluation
    1. History
      1. Clinical Practice Pearl
    2. Physical Examination: Basic Principles
      1. Otoscopic Findings
      2. What's New In The 2013 AAP Guidelines
  9. Diagnostic Studies
  10. Treatment
    1. Antibiotics Versus Placebo
      1. Antibiotics Versus Placebo: The Bottom Line
    2. Initial Antibiotics Versus A Watchful-Waiting Approach
    3. Initial Choice Of Antibiotic
      1. What's New In The 2013 Guidelines
    4. Duration Of Therapy
    5. Antibiotic Dosing
    6. Persistent Acute Otitis Media
    7. Pain Control
      1. Acetaminophen And Ibuprofen
      2. Topical Agents (Antipyrine Solution, Lignocaine, Naturopathic Solution)
      3. Narcotic Analgesics
      4. Other Remedies
      5. Pain Control: The Bottom Line
    8. Decongestants And Antihistamines
    9. Effect Of Age On Treatment
      1. What's New In The 2013 AAP Guidelines
    10. Adverse Events Of Treatment
    11. Complications Of Acute Otitis Media
      1. Mastoiditis
      2. Meningitis
      3. Complications Of Acute Otitis Media: The Bottom Line
    12. Treatment Summary And 2013 American Academy Of Pediatrics Guidelines
  11. Special Circumstances
    1. Patients To Exclude From The Watchful-Waiting Approach
    2. Patients With Bilateral Acute Otitis Media Or Otorrhea
    3. Patients Who Cannot Tolerate Oral Antibiotics
    4. Patients With Penicillin Allergies
    5. Patients With Chronic Suppurative Otitis Media Or Acute Otitis Media Through Tympanostomy Tubes
      1. Patients With Acute Otitis Media Through Tympanostomy Tubes Or Chronic Suppurative Otitis Media: The Bottom Line
  12. Controversies And Cutting Edge
  13. Disposition
  14. Summary
  15. Risk Management Pitfalls For Acute Otitis Media In Children
  16. Time- And Cost-Effective Strategies
  17. Case Conclusions
  18. Clinical Pathway For Suspected Acute Otitis Media In Pediatric Patients
  19. Tables and Figures
    1. Table 1. Differential Diagnosis Of Ear Pain
    2. Table 2. Definitions Of Acute Otitis Media And Otitis Media With Effusion
    3. Figure 1. 2013 American Academy Of Pediatrics Guidelines For Acute Otitis Media
  20. References

Abstract

Acute otitis media is one of the most common pediatric illnesses; however, there is considerable controversy in its management. While most cases are treated with antibiotics, there is a growing concern regarding antibiotic overuse and subsequent drug resistance. Researchers in the Netherlands have developed a “watchful waiting" (ie, an observation approach) that has been successful in treating acute otitis media, although it has not gained widespread popularity in the United States. This review will summarize the latest research on diagnosing acute otitis media as well as different treatment regimens, including the efficacy of the watchful-waiting approach.

Key words: acute otitis media, AOM, otitis media with effusion, watchful-waiting, observation, wait-and-see, ear pain, otalgia, otorrhea, bulging tympanic membrane, AAP guidelines

Case Presentation

A mother has brought her 2 children to the ED on a Saturday evening, with both complaining of ear pain. The first child, a 3-year-old girl, has been complaining of a right-sided earache for the past 2 days. Today, she had a fever of 38.4°C at home. She has been fussier than usual, but she is still active and has been eating normally. She is an otherwise healthy girl and has never been diagnosed with acute otitis media before. On otoscopic exam, the right tympanic membrane is erythematous and bulging, with decreased movement on insufflation.

The second child, the 2-year-old brother of the first patient, has been tugging on his left ear for the past day. Otherwise, he seems fine, although he has a runny nose and has sneezed several times. He has not had a fever and has no medical problems. Although he does not appear to be as sick as his sister, his mother wonders if he has caught the same bug. On his otoscopic exam, there is opacity of the tympanic membranes bilaterally, with retraction and decreased movement of the tympanic membrane with insufflation on the left.

The mother asks you if her children will need antibiotics for an infection. Both children attend daycare, and the mother is worried because other children there have had ear infections. You think:

  • Do these patients have risk factors for acute otitis media?
  • Is either history suggestive of a particular diagnosis?
  • Is either patient’s physical examination consistent with acute otitis media?
  • Are other diagnostic tests necessary?
  • Should I give either of these patients a prescription for antibiotics? If so, which antibiotic should I give, and for how long a duration?
  • What pain medications are appropriate for these patients?
  • What complications should I be worried about?
  • Can I discharge these patients safely? What precautions should I give the parents?

Introduction

Acute otitis media (AOM) is one of the most common infections diagnosed in children in the United States. It accounts for 13% of all emergency department (ED) visits and 30 million clinic visits by children, making it the second leading diagnosis in pediatric ED visits (after upper respiratory infection).1 In 2000, $5 billion was spent on the diagnosis and treatment of AOM.2 Traditional management of AOM – particularly in patients diagnosed in the ED – has included antibiotic therapy. Although a 2002 study found a decrease in the overall populationbased antibiotic prescription rate for AOM,3 a 2007 study reported that up to 91% of ED patients received antibiotic prescriptions for AOM.4 Traditional antibiotic treatment for AOM has been called into question in the past several decades based on early studies that suggested a benign natural history of the disease. A meta-analysis of clinical trials from 1966 to 1992 showed that AOM spontaneously resolved without treatment in 80% of cases, and it concluded that antibiotic prescriptions may not be necessary for all patients.5 Although the results of these studies were later called into question based on their less-than-stringent diagnostic criteria for AOM, researchers began to turn to other models for treating AOM.

For more than 20 years, physicians in the Netherlands have been treating AOM in children with initial observation or a “watchful-waiting” approach. Initial studies demonstrated that this approach was safe, effective, and acceptable to parents. 6,7 As a result of this new treatment paradigm, a national survey of Dutch general physicians found that antibiotics for children with AOM were given in 14% to 20% of diagnosed cases from 1987 to 2001;8 however, more-recent data indicate that antibiotic prescription rates for AOM are increasing in the Netherlands. In 2003, 1 study reported prescription rates of up to 64%,9 and another study reported prescription rates of 40% to 50% from 2002 to 200810 (although these numbers are still lower than their United States counterparts). Although the healthcare system in the Netherlands differs greatly from that in the United States in that many of these patients are treated by their family physicians with close follow-up, researchers began to study this treatment model in the hope that the Dutch system would be applicable to United States physicians and their patients.

The interest in a new treatment model for AOM in the United States was also fueled by the growing rate of antibiotic use and the subsequent concern for antibiotic resistance. Early studies found that, as antibiotic overuse increases, the resistance to penicillin of the Streptococcus pneumoniae bacterium has been increasing (27.5% of strains in 1995 were resistant compared to 43.8% in 1997).11 By comparison, in the Netherlands, resistance rates of S pneumoniae strains to penicillin are very low (as low as < 1%, as reported in a small study involving respiratory isolates in 89 patients).12 With the 2010 introduction of the new pneumococcal conjugate vaccine (PCV13), the microbiology of AOM continues to change, but antibiotic resistance remains a concern.13

In an effort to decrease antibiotic prescribing and antibiotic resistance trends, and building on the successes of the watchful-waiting approach in the Netherlands, the American Academy of Family Physicians (AAFP) and the American Academy of Pediatrics (AAP) released a practice guideline in 2004 that suggested observation without antibiotics in certain cases of AOM.7 Although the 2004 guideline recommendations received significant publicity, adherence to them was not widespread, and data show that there was little difference in antibiotic prescribing rates for AOM after publication.14,15

Since 2004, researchers have begun to scrutinize closely the clinical trials from the past several decades. Many older trials have been criticized because they utilized broad inclusion criteria, leading to inaccurate diagnosis on study entry and creating a study population not reflective of the true AOM population. Many studies included children who did not have AOM, children who often had otitis media with effusion (OME), or children who had no middle ear disease at all. They also excluded very young children, children with severe disease, children with recent antibiotic treatment, and children with recent AOM.16 Newer trials have subsequently included a very strict definition of AOM, prompting the AAP to revise their guidelines in 2013.17 These guidelines continue to recommend an observation approach, but they strongly emphasize appropriate diagnostic criteria. The literature will continue to evolve as better-designed clinical trials are conducted using these criteria. This issue of Pediatric Emergency Medicine Practice will present evidence-based recommendations for the diagnosis of AOM and will review the efficacy of different treatment modalities.

Critical Appraisal Of The Literature

A literature search was performed using the PubMed and Ovid MEDLINE® databases. Searches were limited to studies in English involving human subjects. Studies were limited to clinical trials, meta-analyses, practice guidelines, randomized controlled trials (RCTs), review articles, and systematic reviews. Prospective and retrospective cohort studies were used for the epidemiology section. Search terms included: acute otitis media, children, treatment, and emergency department. This search yielded 1208 studies; however, articles related to prevention or prophylaxis of AOM, chronic otitis media (OM), myringotomy/tympanostomy tubes, or upper respiratory infections (in general) were not reviewed. The Cochrane Database of Systematic Reviews was searched for reviews using the same terms as above,7 and relevant reviews were identified. The Database of Abstracts of Reviews of Effectiveness (DARE) was searched using the terms as above and identified 8 relevant reviews. Additionally, the National Guideline Clearinghouse (www.guideline.gov) was explored, and 1 guideline was found.

In 2004, the AAP and the AAFP partnered with the Agency for Healthcare Research and Quality (AHRQ) and the Southern California Evidence-Based Practice Center to develop a set of clinical practice guidelines for the management of AOM.7 These guidelines were based largely on data gathered for the 2001 evidence report of AOM management published by the AHRQ.18 The issues addressed in the AAP/AAFP guidelines were: (1) the definition of AOM; (2) the natural history of AOM without antibacterial treatment; (3) the effectiveness of antibacterial agents in preventing clinical failure; and (4) the relative effectiveness of specific antibacterial regimens. Their search of the literature from 1966 to 1999 uncovered 3461 articles, and 74 studies were reviewed in full. The published clinical practice guidelines were systematic, evidence based, and peer reviewed. Subsequent to the 2004 publication of the guidelines, the AHRQ issued a 2010 update to their 2001 evidence report.19 This resource was also extensively reviewed and provided a critical analysis of the latest research addressing the following: (1) the clinical symptoms and otoscopic findings to diagnose AOM; (2) the impact of the pneumococcal heptavalent immunization (PCV7) on AOM microbial epidemiology; (3) the comparative effectiveness of different treatment options for treating uncomplicated AOM in average-risk children; (4) the comparative effectiveness of different management options for recurrent OM and persistent OM or relapse of AOM; (5) the treatment outcomes based on the following characteristics: laterality, otorrhea or perforation, severity, comorbidities, age groups, race, ethnicity, or daycare attendance; and (6) adverse effects of treatment.

In 2013, the AAP again partnered with the AHRQ and the Southern California Evidence-Based Practice Center to publish an update of the 2004 guidelines.17 The 2013 guidelines address appropriate diagnosis of AOM using a strict definition, pain management, initial observation versus antibiotic treatment, appropriate choices of antibiotics, and preventative measures. These guidelines are based largely on the 2010 AHRQ update as well as continued review of newly published literature. This source represents the most current review of the literature on AOM.

Overall, the diagnosis and treatment of AOM has been a well-studied topic. There are many large RCTs, meta-analyses, and systematic reviews addressing the management of AOM. Differences in study design (particularly diagnostic criteria for inclusion or exclusion of subjects and definitions of clinical success or failure) have made it difficult to compare different studies. The biggest flaw in the AOM literature is the lack of a strict definition of AOM for study participants. Many studies (particularly older studies prior to 2000) included subjects that did not have AOM by the current definition but had either OME or a normal variant. It is difficult to draw conclusions from these studies because a true population of AOM was not studied; however, recent studies have applied strict inclusion criteria to study participants, and this topic has been extensively discussed in the 2013 AAP guidelines as well as throughout this article.

Risk Management Pitfalls For Acute Otitis Media In Children

  1. “I gave the patient a script for antibiotics, so he didn't need pain medication.” Always treat a patient’s pain, regardless of the choice to give antibiotics. Ibuprofen and/or acetaminophen are first-line therapies, but topical analgesics may be used as well. Narcotics should be reserved for children with severe otalgia resistant to first-line therapies.
  2. “The child had a red TM on otoscopic examination, so I treated him for AOM.” Erythema of the TM alone is not specific for AOM. The TM can be red for other reasons, including crying, high fever, and manipulation of the ear canal (such as from cerumen removal). A slightly red TM alone is not predictive of AOM, while a distinctly red or hemorrhagic TM is slightly suggestive. The diagnosis of AOM correlates most with mobility and position (a bulging, immobile TM). The 2013 AAP guidelines require a bulging TM and evidence of middle ear effusion on pneumatic otoscopy for diagnosis of AOM.
  3. “It was difficult to perform an otoscopic examination on this child, so to be safe, I skipped it and diagnosed him with AOM and treated him with antibiotics.” Clinicians should make their best effort to perform an adequate otoscopic examination in children to spare them from unnecessary antibiotics. The child should be calmed and placed in the caregiver’s lap for examination. Cerumen should be removed if it obstructs the view of the TM (this can be achieved with docusate sodium and irrigation or by manual extraction). The emergency clinician should perform pneumatic otoscopy on all patients to confirm the presence of a middle ear effusion. Certain patients with a definitive diagnosis of AOM may not require antibiotics.
  4. “This patient had ongoing ear pain for morethan 1 week and signs of middle ear effusion on otoscopic examination but no TM bulging. I treated her with antibiotics.” There is no evidence that antibiotics are beneficial for OME. OME, by definition, is not an acute process. AOM requires moderate to severe bulging of the TM or acute onset of symptoms ( < 48 h) plus mild TM bulging or intense erythema of the TM for diagnosis.
  5. “This patient returned to the ED with persistent middle ear effusion after an episode of AOM. This represented a failure of treatment, so I prescribed a stronger antibiotic.” Persistent middle ear effusion is very common after an episode of AOM, but it should resolve after 3 months. Patients with persistent effusions should be referred to their pediatrician, as they may need further testing to assess for hearing loss or cognitive delays. There is no need to change their antibiotic regimen.
  6. “I was worried that this patient with AOM would develop a serious complication such as mastoiditis or meningitis if I didn't treat him with antibiotics.” There is no evidence that delayed or withdrawn antibiotics are associated with mastoiditis or meningitis, which are extremely rare complications of AOM. Some studies have shown an association between mastoiditis and recent antibiotic use. Do not prescribe antibiotics solely to avoid these complications.
  7. “My patient had a history of recurrent AOM and presented to the ED today with ear pain and findings of AOM on otoscopy. He had no fever and looked well, so I treated him with the watchful-waiting approach.” History of recurrent AOM was considered a contraindication to observation in the 2004 AAP/AAFP guidelines. The 2013 guidelines do not specifically list recurrent AOM as a contraindication to observation; however, management of these patients can be difficult. Emergency clinicians should consider consulting a specialist or discussing the case with the child’s pediatrician before initiating treatment. Some patients with recurrent AOM may benefit from tympanocentesis to isolate the causative middle ear pathogen, a procedure rarely performed in the ED. The 2013 AAP guidelines recommend amoxicillin-clavulanate (or an alternative antibiotic with beta-lactamase coverage) for patients with a history of recurrent AOM unresponsive to amoxicillin.
  8. “These parents seem pretty aggressive. They won’t be happy if I don’t treat their child with antibiotics. Even if I give them a script to hold and instruct them to fill it in 48 to 72 hours if the child does not improve, they’ll probably just go straight to the pharmacy from the ED to fill it.” Recent studies have shown that parents are satisfied with a watchful-waiting approach as long as the child’s pain is addressed. Around 80% of parents did not fill their prescription. It is important for emergency clinicians to explain their instructions clearly, provide reassurance, and treat pain. Note that if the child has had multiple previous episodes of AOM that were treated with antibiotics, the parents are more likely to fill the prescription than if this is the child’s first episode.
  9. “This child had AOM. I got a complete blood count to see how high his white count was and a culture of his ear drainage to see what the inciting pathogen was.”Routine complete blood counts are not recommended in nonsevere AOM as they do not contribute to management. In an immunocompromised patient, they may be helpful. Routine culture and gram stain of middle ear fluid is not recommended, although it may help guide treatment in patients with persistent AOM or chronic AOM.
  10. “This child had AOM. Antibiotics are very safe drugs, so I didn't have to worry about adverse reactions from treatment.” While antibiotics are some of the safer drugs on the market, they are not without side effects. Diarrhea, vomiting, and rash are commonly seen in children prescribed antibiotics for AOM and the risk is greater for children who receive broad-spectrum antibiotics such as moxicillinclavulanate. Parents should be educated about possible side effects when children need to be treated with antibiotics.

Tables and Figures

Table 1. Differential Diagnosis Of Ear Pain

Table 2. Definitions Of Acute Otitis Media And Otitis Media With Effusion

References

Evidence-based medicine requires a critical appraisal of the literature based upon study methodology and number of subjects. Not all references are equally robust. The findings of a large, prospective, randomized, and blinded trial should carry more weight than a case report.

To help the reader judge the strength of each reference, pertinent information about the study, such as the type of study and the number of patients in the study will be included in bold type following the references, where available. The most informative references cited in this paper, as determined by the author, will be noted by an asterisk (*) next to the number of the reference.

  1. Pitts SR, Niska RW, Xu J, et al. National hospital ambulatory medical care survey: 2006 emergency department summary. Natl Health Stat Report. 2008;7:1-38. (Retrospective epidemiological study)
  2. Bondy J, Berman S, Glazner J, et al. Direct expenditures related to otitis media diagnoses: extrapolations from a pediatric Medicaid cohort. Pediatrics. 2000;105(6):E72. (Economic analysis; 87,057 patients)
  3. McCaig LF, Besser RE, Hughes JM. Trends in antimicrobial prescribing rates for children and adolescents. JAMA. 2002;287(23):3096-3102. (Retrospective epidemiological study; 6500-13,600 pediatric visits)
  4. Fischer T, Singer AJ, et al. National trends in emergency department antibiotic prescribing for children with acute otitis media, 1996–2005. Acad Emerg Med. 2007;14(12):1172-1175. (Retrospective epidemiological study)
  5. Rosenfeld RM, Vertrees JE, Carr J, et al. Clinical efficacy of antimicrobial drugs for acute otitis media: meta-analysis of 5400 children from 33 randomized trials. J Pediatr. 1994;124(3):355-367. (Meta-analysis; 5400 patients)
  6. van Buchem FL, Peeters MF, van Hof MA. Acute otitis media: a new treatment strategy. Br Med J (Clin Res Ed).1985;290(6474):1033-1037. (Retrospective case study; 4860 patients)
  7. * Subcommittee on Management of Acute Otitis Media. Diagnosis and management of acute otitis media. Pediatrics. 2004;113(5):1451-1465. (Practice guideline)
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  10. Uijen HJ, Bindels PJ, Schellevis FG, et al. ENT problems in Dutch children: trends in incidence rates, antibiotic prescribing, and referrals 2002-2008. Scand J Prim Health Care. 2011;29(2):75-79. (Retrospective epidemiological study)
  11. Doern GV, Pfaller MA, Kugler K, et al. Prevalence of antimicrobial resistance among respiratory isolates of Streptococcus pneumoniae in North America: 1997 results from the SENTRY antimicrobial surveillance program. Clin Infect Dis. 1998;27(4):764-770. (Multicenter laboratory molecular epidemiology study; 1047 total respiratory isolates; 845 isolates from United States laboratories; 202 isolates from Canadian laboratories)
  12. Hermans PW, Sluijter M, Elzenaar K, et al. Penicillinresistant Streptococcus pneumoniae in the Netherlands: results of a 1-year molecular epidemiologic survey. J Infect Dis. 1997;175(6):1413-1422. (Retrospective laboratory molecular epidemiology survey; 89 respiratory isolates)
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  16. Pichichero ME, Casey JR. Diagnostic inaccuracy and subject exclusions render placebo and observational studies of acute otitis media inconclusive. Pediatr Infect Dis J. 2008;27(11):958- 962. (Review of 12 observational studies and 13 natural history studies)
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  18. * Marcy M, Takata G, Chan LS, et al. Management of acute otitis media. Evidence Report/Technology Assessment No. 15. AHRQ Publication No. 01-E010. Rockville, MD: Agency for Healthcare Research and Quality; 2001. (Evidence-based review)
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  49. Karma PH, Penttila MA, Sipila MA, et al. Otoscopic diagnosis of middle ear effusion in acute and non-acute otitis media: the value to different otoscopic findings. Int J Pediatr Otorhinolaryngol. 1989;17(1):37-49. (Prospective study; 2911 patients)
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Chadd E. Nesbit, Margaret C. Powers

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