Acute Otitis Media Treatment & Management

Acute otitis media (AOM) has been described as a self-limiting disease, provided that the patient does not develop a complication. This is an old description that has a renewed relevance. In the new millennium, practitioners are forced to learn the lessons of history because these may serve as our models of practice without effective antimicrobial agents. Nevertheless, for the time being, antibiotics remain the initial therapy of choice for AOM.

Other pharmacologic therapies have also been used to treat AOM. Analgesics and antipyretics have a definite role in symptomatic management. Decongestants and antihistamines do not appear to have efficacy either early or late in the acute process, although they may relieve coexistent nasal symptoms. Systemic steroids have no demonstrated role in the acute phase.

Tympanocentesis and myringotomy are the procedures used to treat AOM. Certain patients require ventilation or drainage of the middle ear cleft for an extended period or have a history of repetitive attacks; these patients benefit from placement of a tympanostomy tube at the time of myringotomy.

Consultation is seldom necessary, although some otolaryngologists might be more comfortable having the pediatrician provide all the primary care.

At present, a chorus of advocates recommends withholding antibiotic therapy for patients with AOM and following a “watchful waiting” or “wait and see” approach. As expected from long-known data, most children managed in this fashion do well, although a study from England observed an increase in the rate of mastoiditis in children that was, essentially, the inverse of the rate of decrease in prescriptions for acute otitis.

A literature review by Thomas et al, which included scrutiny of evidence-based AOM recommendations, particularly those found in current American guidelines, concluded that the data used to compare the usefulness of prompt antibiotic therapy with 2-3 days of watchful waiting are not completely consistent. The investigators stated that controlled trials with well-defined endpoints are still needed to better address the question. ^[22]

A randomized, double-blind, placebo-controlled study indicated that in children with AOM, antimicrobial treatment may prove most beneficial for those with a severely bulging tympanic membrane, while initial observation may be the best course for children with a peaked tympanogram (A and C curves). The study involved patients aged 6 to 35 months. ^{[23, 24]}

Results from another randomized, placebo-controlled study indicated that antimicrobial treatment of AOM-related middle ear effusion is effective even in older children. In the Finnish study, of 84 children aged 6 months to 15 years, 50% of the patients were treated with antibiotics, with middle ear effusion resolving an average of 2 weeks earlier in these children than it did in patients who did not receive antibiotics. Reduction of mean duration of ear effusion by age was as follows ^{[25, 26]} :

• < 2 years: 8 days

• Age 2-6 years: 20 days

• >6 years: 1 day

General principles

Despite the advocates of watchful waiting, the overwhelming consensus is still that antibiotics are the initial therapy of choice for AOM, for 3 valid reasons:

• After the institution of antibiotic therapy, a marked decline in the suppurative complications of AOM is noted

• Practitioners cannot predict with certainty which patients will develop complications

• Studies have demonstrated that the use of antibiotics improves patient outcomes in both early and late phases of AOM

Some order has been brought to the discussions of antibiotic use under the auspices of the Centers for Disease Control and Prevention (CDC) and by the Agency for Health Care Policy and Research (AHCPR), both agencies of the US government. The CDC published 6 principles of appropriate antibiotic use in an attempt to bring precepts of good public health and responsible therapy to the discussion while minimizing the selection of resistant strains of bacteria within the community. These principles are as follows:

• Episodes of otitis media should be classified as AOM or otitis media with effusion (OME)

• Antimicrobials are indicated for treatment of AOM; however, diagnosis requires documented middle ear effusion and signs or symptoms of acute local or systemic illness

• Uncomplicated AOM may be treated with a 5- to 7-day course of antimicrobials in certain patients older than 2 years

• Antimicrobials are not indicated for the initial treatment of OME; treatment may be indicated if effusions persist for longer than 3 months

• Persistent OME after therapy for AOM is expected and does not require repeat treatment with antimicrobials

• Antimicrobial prophylaxis should be reserved for controlling recurrent AOM, defined as 3 or more distinct, well-documented episodes in 6 months or 4 or more episodes in 12 months

Choice of regimen

In the absence of culture results obtained from tympanocentesis, selection of an antibiotic should have the following 2 objectives:

• The antibiotic should cover most of the common bacterial pathogens (see Etiology)

• The antibiotic must be individualized for the child with regard to allergy, tolerance, previous exposure to antibiotics, cost, and community resistance levels

The duration of therapy is also empirically determined to some degree, and data indicate that significant numbers of children do not receive prescribed antibiotics beyond relief of acute symptoms. Traditionally, therapy is continued for 10-14 days; this is convenient for office scheduling, but it may not necessarily be more efficacious than 5 or even 2 days of therapy.

Short-duration therapy may not be appropriate in children younger than 2 years who appear prone to failure even after 14 days of therapy. Mandel showed that when an effusion-free ear was the prime objective, 20 days of antibiotic therapy achieved better outcomes than 10 days of therapy or placebo; however, after 90 days, no difference in the groups existed and recurrence was not prevented by the additional therapy.

Recommendations for administration of prescribed antimicrobials to treat AOM may differ from recommendations for the same antibiotic when used for soft tissue infections.

Pulse-dosing antibiotics, when administered for infections of hollow organs, such as the ear or sinuses, appear to be efficacious as a result of some more obscure antimicrobial mechanisms, increased compliance on the part of the patient or parent, and slower penetration into and removal from middle ear effusion.

Subminimal serum levels of antibiotics have been shown to disrupt adhesive bonds between bacteria and mucosal cell walls and to provide a postantibiotic effect, in which the reproduction of bacteria is disrupted for a period of hours after antibiotic exposure. Similarly, a leukocyte-enhancing action has been demonstrated at these low concentrations.

When antibiotics are used in this manner, marked variations are found in both the effectiveness of individual agents and the susceptibility of individual pathogens. Generally, beta-lactam antibiotics are most successful against gram-positive pathogens for both disruption of adhesion and postantibiotic effect.

Amoxicillin (or erythromycin-sulfisoxazole, in patients who are allergic to penicillin) remains the initial treatment of choice in children with AOM.

With the emergence of resistant strains, the practitioner may need to select an alternative antimicrobial regimen that includes either a broad-spectrum beta-lactamase–resistant cephalosporin or a combined formulation such as amoxicillin-clavulanate or trimethoprim-sulfamethoxazole. Combination therapy may help prevent the emergence of resistance by mutation, provided the pathogen is initially sensitive to both components (see Medication).

With the emergence of multidrug-resistant S pneumoniae (MDRSP), oral therapy consisting of amoxicillin and amoxicillin-clavulanate may have efficacy when the total amoxicillin dose reaches 80-100 mg/kg/d.

If a child does not respond to an antibiotic within 48 hours and concurrently develops local and systemic signs of toxicity, the pathogen may be resistant to the selected drug. Treatment options include an empiric change of antimicrobial agent or a drainage procedure with culture. In children with prolonged acute symptoms, failure to improve with antibiotic therapy may indicate coexistent viral infection.

Surgical management of AOM can conveniently be divided into 3 related procedures:

• Tympanocentesis

• Myringotomy

• Myringotomy with insertion of a ventilating tube

Indications for these 3 procedures may be diagnostic, therapeutic, or prophylactic. More than 1 indication for a procedure may have to be considered on a case-by-case basis. Selection of the appropriate procedure results from evaluation of patient factors, surgeon factors, available resources, and urgency. Each of these aspects must be examined to select that procedure that gives the optimal predicted outcome.

Tympanocentesis

Tympanocentesis, in its purest form, is a diagnostic procedure that gives the clinician access to acute or chronic middle ear effusions for culture and other evaluations. However, it can also be employed in a therapeutic setting. Additionally, tympanocentesis remains a valuable research tool in the evaluation of new antimicrobial agents for efficacy in AOM and for identification of host defense mechanisms or flaws in the middle ear immunochemistry.

Consider tympanocentesis in the following patients:

• Children who are immunosuppressed or immunocompromised

• Neonates with AOM (who are more likely to have an unusual or more invasive pathogen)

• Patients in whom antimicrobial therapy has failed and who continue to experience local or systemic signs of sepsis

• Patients who have had a complication of AOM in conjunction with attempts to recover the etiologic agent from other sites (eg, cerebrospinal fluid [CSF] or blood)

Generally, tympanocentesis is performed without anesthesia after sterilization of the ear canal with isopropyl alcohol or povidone-iodine solution. Insert a needle through the anterior portion of the tympanic membrane, and aspirate the contents of the middle ear into a sterile trap for identification of microbes and their properties.

A tympanocentesis may be converted to a myringotomy (see below) and rendered therapeutic by enlarging the hole in the tympanic membrane, often by spreading the edges with microalligator forceps or suction tip. Instilling antibiotic drops and suctioning the middle ear are possible through the myringotomy. Typically, the patient experiences prompt relief of local symptoms. Culture results must be obtained before extension of the incision.

Myringotomy

Myringotomy is the incision and drainage procedure for AOM. It is a product of technology that allows the illumination of the tympanic membrane, with or without magnification. A myringotomy may be an extension of a tympanocentesis (see above) or a separate incision of the tympanic membrane to provide drainage of the middle ear cleft to the ear canal.

In this procedure, the tympanic membrane is incised with a knife, and the resulting opening allows a fluid-filled middle ear to drain to the ear canal and the exterior. Depending on the size of the hole and the method used to create it, the tympanic membrane usually returns to normal within days to a few weeks.

A number of instruments, from knives to lasers, are available to perform this task, but the basic principles remain constant. The hole design, established either by size, by the application of material to retard healing, or by the type of initial tissue damage, is the primary factor in controlling how long the perforation remains open, which, in turn, is determined by patient need.

The use of a carbon dioxide laser in myringotomy on children with AOM has been promoted widely and directly to the consumer by the manufacturers of these instruments; proponents claim to have ushered in a new treatment for AOM without the use of antimicrobials. This approach is undoubtedly a boon for the otolaryngologist who is less technically adept, but to date, it has yielded little or no change in efficacy over standard myringotomy.

Myringotomy with ventilation tube

Some patients with AOM require ventilation or drainage of the middle ear cleft for an extended period (eg, patients with mastoiditis), whereas others may have a history of repetitive attacks. These patients benefit with the placement of a tympanostomy tube at the time of myringotomy. In most instances, general anesthesia or sedation is necessary in older children because topical anesthesia is relatively ineffective in acutely inflamed tympanic membranes.

Numerous tube designs are now available, each with its own weaknesses and strengths with respect to retention, reactivity, and complications. Selection of any tympanostomy tube design is governed by the length of time for which ventilation is likely to be needed. Tubes may be designed to permit tube placement for 6-9 months, for 9-18 months, or for longer than 2 years. Selection is also governed by the quality of the tympanic membrane’s fibrous tissue and by patient need versus the increasing complication rates associated with prolonged ventilation.

With increasing antimicrobial resistance, surgical intervention in the form of tympanostomy tube placement can be expected to increase in the coming years, after having fallen into disfavor in the past 2 decades when resistance was less of a factor. In the author’s practice, children younger than 15 months and those who attend day care centers are most likely to require surgery.

In a report on 248 pediatric patients who received tympanostomy tubes and postoperative otic drop therapy, Conrad et al found that tube occlusion occurred most frequently in patients with middle ear fluid and in those with longer time to postsurgical follow-up. The investigators, who conducted a retrospective medical record review, found that at first follow-up, one or both tubes were occluded in 10.6% of patients. Children with no serous fluid were found to be 3 times more likely to have unobstructed tubes than were children with fluid. It was also found that the chance of occlusion increased in relation to the amount of time that existed between surgery and follow-up. ^{[27, 28]}

Mastoidectomy

Mastoidectomy predates the extensive use of tympanic membrane incision, primarily because of the severity of the disease and the relatively frequent occurrence of spontaneous perforation in otitis-prone individuals. For example, in Eskimo communities of northern Canada, native Inuit are often found with large central perforations from chronic otitis.

Contraindications for surgical therapy

Contraindications for incision of the tympanic membrane are relatively few in the presence of acute disease. In 25 years of practice, the author has twice managed to tap through “thick tympanic membranes” to find himself aspirating CSF from low-hanging and exposed dura (one associated with a porencephalic cyst). Neither resulted in a prolonged complication, but CSF may be obtained with considerably less excitement via lumbar puncture.

Patients with patulous eustachian tubes most frequently have persistent otorrhea after placement of tympanostomy tubes. Children with neuromuscular disease, unrepaired cleft palates, or Down syndrome are more prone to this outcome. Otorrhea may be the lesser evil when the child is septic or uncomfortable or when damage to the middle ear cleft is imminent. This contraindication is a relative one, and the parent must be informed of the risk and allowed to participate in the decision whether to proceed.

Complications of surgical therapy

Complications of tympanocentesis and myringotomy are few and rare in appropriately performed procedures in children with otherwise normal anatomy. They include the following:

• Immediate complications - Injury to the skin of the ear canal; injury to the ossicular chain

• Intermediate complications - Persistent otorrhea; persistent perforation; external otitis from persistent drainage; implantation cholesteatoma

• Long-term complications - Persistent perforation, with or without otorrhea; ear canal stenosis

The complications for myringotomy with ventilation tube placement are the same, with the addition of those related to the tube and to longer perforation.

With tubes of modern design, medialization is now quite rare. Some tube designs have a tendency to collect epithelial debris and inherently have a higher rate of cholesteatoma formation. As a rule, longer ventilation increases the likelihood of persistence of the perforation, the formation of aural polyps, and chronic otorrhea. Most of these complications are reversed by removal of the tube, with or without repair of the hole with a small myringoplasty.

Children with recurrent AOM have no effusion within the middle ear cleft between attacks of acute disease. Management of this condition is confined to either episodic management or preventive treatment.

In episodic management, each episode is considered a new attack and is treated with antibiotics; the patient is monitored until the episode resolves. Preventative treatment involves the administration of a conjugated heptavalent pneumococcal vaccine. Although the vaccine is intended to combat invasive effects in infants, immunized children have a reduced incidence of AOM, a reduced need for antibiotic therapy or tympanostomy tubes, and a reduced risk of invasion or hearing loss. ^[29]

Since the introduction of the heptavalent pneumococcal vaccine in 2000, researchers have found that nearly two thirds of invasive pneumococcal disease cases in young children have been caused by 6 serotypes that were not included in that vaccine. Those serotypes, along with the original 7, have been incorporated into pneumococcal vaccine valent-13 (Prevnar 13) that was approved in February 2010.

A study by Hasegawa et al indicated that the introduction of a heptavalent pneumococcal conjugate vaccine to Japan in 2009 significantly reduced the risk of AOM in infants and young children. The study, in which 614 parents were surveyed, found that, after adjustment for potentially confounding variables, the hazard ratio for AOM in vaccinated children was 0.33, with significant risk reduction in children between infancy and age 3 years and in young children over age 3 years. ^[30]

Similarly, a study by Tawfik et al indicated that since the introduction of pneumococcal vaccination, hospital admissions for pediatric AOM/complications of AOM in the United States have decreased in prevalence, as have admission rates for pediatric pneumococcal meningitis with AOM/complications of AOM. Using information from the Kids’ Inpatient Database from between 2000 and 2012, the study found particularly sharp declines in admissions for children under age 1 years, from 22.647 to 8.715 per 100,000 persons, and for children aged 1-2 years, from 13.652 to 5.554 per 100,000 persons. ^[31]

A study by Kaur et al indicated that the introduction of 7-valent and 13-valent pneumococcal conjugate vaccine (PCV7 and PCV13) has reduced the prevalence of AOM in children aged 3 years or younger. The report found that out of 615 children, all of whom were vaccinated with PCV7 or PCV13, 60% suffered one or more episodes of AOM by age 3 years, and 24% experienced three or more episodes. In comparison, a 1989 study, conducted by Teele et al prior to the introduction of PCVs, found that by age 3 years, 83% of children followed experienced at least one episode of AOM, while 46% suffered three or more episodes. Kaur et al also attributed the change in AOM prevalence to more stringent criteria used to differentiate AOM from otitis media with effusion. ^{[32, 33, 34]}

If immunologic therapy to prevent AOM is to be found, however, vaccines that are effective against nontypeable H influenzae, as well as all serotypes of S pneumoniae, will have to be developed. Some progress is being made with the former. ^[35] As yet, however, no vaccine exists for nontypeable H influenzae. Correspondingly, research has been commenced on immunization against the common viruses that induce AOM—namely, respiratory syncytial virus (RSV), adenoviruses, influenza A and B viruses, and rhinoviruses.

Antibiotic prophylaxis is becoming less popular as resistant strains emerge. Amoxicillin and sulfisoxazole have both been used extensively. The former has better coverage against S pyogenes but may promote nasopharyngeal colonization with beta-lactam–resistant pneumococci and H influenzae. Reserve prophylaxis for otitis-prone children who are younger than 2 years or in day care and who have had 3 or more attacks in a 6-month period. Both amoxicillin and sulfisoxazole can cause serum sickness reactions.

A potential preventative measure is the natural sugar substitute, xylitol. Studies indicate that xylitol chewing gum, lozenges or syrup may reduce the occurrence of AOM by as much as 25%. ^[36] However, a study by Danhauer et al suggested that most parents are unaware that xylitol can prevent AOM and would be unlikely to use it in their preschool- and kindergarten-aged children. Nonetheless, the investigators, who employed an Internet questionnaire, did find that parents who were previously aware of xylitol as a preventive and who had children with a history of AOM would be more likely to give it to their youngsters. ^[37]

Tympanostomy tube placement decreases episodes of AOM. Ventilation has been used more frequently when evidence of MDRSP exists. In the author’s practice, resistance is noted most frequently in infants and children aged 6-14 months who are in day care.

Tympanostomy tubes are also beneficial in children with recurrent AOM and coexistent reactive airway disease and should be considered when recurrent episodes of AOM destabilize control of other systemic conditions. Examples include alterations in seizure thresholds, otitic hydrocephalus, or control of diabetes. Similarly, early tympanostomy tube placement might be considered for children with sensorineural hearing loss, speech development abnormalities, or learning dysfunction to give the child a consistent hearing model.

Control of nasal inflammation in children, whether caused by an allergy or by recurrent infection, appears to decrease the recurrence of AOM. Trials are being conducted to determine the efficacy of topical nasal steroids for decreasing middle ear disease, in an attempt to confirm anecdotal information that supports this treatment modality.

Some of the risk factors for AOM (see Etiology) can be removed by such efforts as altering child care arrangements, providing a tobacco-free living space, and stopping bottle use in children older than 1 year.

In children with recurrent AOM, adenoidectomy has demonstrated efficacy. However, determining which children will benefit from this treatment modality is not yet possible. Few pediatric otolaryngologists recommend adenoidectomy initially over tympanostomy tube placement alone, unless coexistent nasal symptoms are present. The procedure might be considered for older children who require replacement of their tympanostomy tubes. As additional information on the role of biofilm in the nasopharynx becomes available, the selection of candidates for adenoidectomy with or without tube placement is likely to improve.

Reexamine patients within 48 hours if no evidence of decreasing acuity manifests, if symptoms become more severe, or if a complication becomes evident. Otherwise, follow-up care is normally scheduled 10-14 days after the acute event.

Persistent middle ear effusion should be expected at the initial follow-up visit; statistically, only 30% of patients show complete resolution. In the absence of acuity, further treatment is unwarranted, but the patient should be scheduled to return at intervals until the effusion resolves. The author often gives parents an “emergency prescription” to be filled if the child with fluid in the middle ear develops acute symptoms prior to the next scheduled visit. In addition to decreasing off-hours calls, this provides the parent with a sense of security.

In a study of 1208 children, aged 6-24 months, Grindler and colleagues concluded that the health-related quality of life in children with recurrent otitis media was significantly worse than it was in healthy youngsters. In addition, in children with recurrent otitis media, myringotomy tube placement was associated with increased quality-of-life scores. ^[38]