Acute otitis media in children: Treatment

INTRODUCTION — Acute otitis media (AOM), also called purulent otitis media and suppurative otitis media, is a common problem in children and accounts for a large proportion of pediatric antibiotic use.

The treatment of uncomplicated AOM will be reviewed here. The epidemiology, pathogenesis, diagnosis, complications, and prevention of AOM are discussed separately, as is otitis media with effusion (serous otitis media).

●(See "Acute otitis media in children: Epidemiology, microbiology, and complications".)

●(See "Acute otitis media in children: Clinical manifestations and diagnosis".)

●(See "Acute otitis media in children: Prevention of recurrence".)

●(See "Otitis media with effusion (serous otitis media) in children: Clinical features and diagnosis".)

●(See "Otitis media with effusion (serous otitis media) in children: Management".)

DIAGNOSIS OF AOM — The clinical diagnosis of AOM requires one or more of the following [1,2] (see "Acute otitis media in children: Clinical manifestations and diagnosis", section on 'Diagnosis'):

●Bulging of the tympanic membrane (picture 1) – Children with severe/marked bulging of the tympanic membrane appear to benefit most from antibiotic therapy [3]. Bulging of the tympanic membrane is more likely to be associated with a bacterial pathogen in the middle ear [4,5].

●Signs of acute inflammation (eg, marked erythema of the tympanic membrane and fever or ear pain) and middle ear effusion – Although signs of acute inflammation and middle ear effusion without bulging may represent early AOM, it is challenging for young children to localize pain to the ear [1,2].

●Perforation of the tympanic membrane with acute purulent otorrhea if acute otitis externa has been excluded. (See "External otitis: Pathogenesis, clinical features, and diagnosis", section on 'Diagnosis'.)

Accurate diagnosis ensures appropriate treatment for children with AOM, who require antibiotic therapy, and avoidance of antibiotics in children with otitis media with effusion, in whom antibiotics are unnecessary.

CLINICAL COURSE WITHOUT ANTIBIOTICS — The acute symptoms and signs of AOM often resolve within three days whether or not children are treated with antibiotics [6-8]. Antibiotic administration has been demonstrated to slightly hasten the resolution of pain. In a meta-analysis of seven randomized trials comparing antibiotics with placebo in 2320 children with AOM, 16 percent of those who did not receive antibiotics continued to have pain at two to three days (as compared with 11 percent of children who received antibiotic therapy) [9]. In a separate meta-analysis of randomized and observational studies in 1409 children who did not receive antibiotics, ear pain resolved within three days in 50 percent and within seven to eight days in 90 percent [8]. (See 'Antibiotic therapy versus observation' below.)

Middle ear effusion associated with AOM usually resolves spontaneously within several weeks, often by four to six weeks (figure 1) [10-13]. The clinical features, complications, and management of persistent middle ear effusion are discussed separately. (See "Otitis media with effusion (serous otitis media) in children: Clinical features and diagnosis" and "Otitis media with effusion (serous otitis media) in children: Management".)

MANAGEMENT OF PAIN — Pain management is a mainstay of the treatment of AOM in children [1,14]. We provide treatment to reduce ear pain in children whether or not they are treated with antibiotics. Pain is a common feature of AOM and may be severe [6].

●Oral and topical analgesics – We suggest oral ibuprofen or acetaminophen rather than other interventions for treatment of ear pain in children with AOM. With severe pain unresponsive to either ibuprofen or acetaminophen alone, a combination of both ibuprofen and acetaminophen may be needed.

Although topical anesthetics applied to the tympanic membrane appear to be effective in relieving ear pain [15,16], they are not licensed for this indication in the United States. In addition, the US Food and Drug Administration added a boxed warning to viscous lidocaine after severe adverse events were reported in infants and children (primarily when it was used for teething or stomatitis). Topical procaine or lidocaine preparations should be used with caution in children and avoided in those with tympanic membrane perforation. Topical benzocaine is avoided in children <2 years because of the risk of methemoglobinemia [17]. (See "Methemoglobinemia", section on 'Topical anesthetics'.)

Limited evidence from randomized trials suggests that ibuprofen, acetaminophen, and topical analgesics are effective in reducing ear pain compared with placebo or no treatment [18,19]. In a systematic review of randomized trials of nonsteroidal anti-inflammatory drugs and acetaminophen for pain relief in AOM that included 219 children, fewer children in the ibuprofen (7 percent) or acetaminophen (10 percent) groups than in the placebo group (25 percent) had pain at 48 hours, with no difference in the rate of adverse effects; all of the children received antibiotics [18]. Ibuprofen and acetaminophen appeared to be equally effective, although data were limited.

We suggest not applying heat or cold to the external ear or instillation of olive oil or herbal extracts into the external auditory canal to treat pain in children with AOM. The effectiveness of these therapies is unproven and they may be harmful [1].

●Therapeutic tympanocentesis – Therapeutic tympanocentesis or myringotomy may be helpful in children with severe pain unresponsive to both analgesia and antibiotic treatment [20]. Therapeutic tympanocentesis or myringotomy are rarely needed but may be necessary with AOM caused by multidrug resistant otopathogens. It also may have other benefits. In a longitudinal prospective study, tympanocentesis with complete evacuation of middle ear fluid in combination with antimicrobial therapy was associated with decreased risk of treatment failure, becoming otitis prone, and tympanostomy tube placement [21,22]. Even if middle ear pus is not evacuated, tympanocentesis creates a pathway that may permit drainage (otorrhea), which reduces pressure and pain in the middle ear.

●Prevention of ear pain during airplane descent – Children with eustachian tube dysfunction, including those with AOM, may have ear pain during airplane travel, particularly during airplane descent [23,24]. With airplane descent, the pressure in the cabin increases to that at landing altitude. If middle ear pressure does not increase accordingly (ie, if the eustachian tube "locks in" the reduced pressure due to obstruction of the nasopharyngeal orifice), the tympanic membrane may be forced medially and stretched, which can lead to painful barotrauma: bleeding into the tympanic membrane (picture 2), formation of fluid exudates in the middle ear, and occasionally tympanic membrane rupture [25]. (See "Ear barotrauma", section on 'Etiologies'.)

Although interventions to equalize middle ear and atmospheric pressure have not been well studied in controlled trials, the following interventions may help to open the eustachian tube to equalize middle ear pressure during descent [26]:

•For infants and young children – Sucking on a pacifier or bottle; suctioning the nose with a nasal bulb

•For older children – Chewing on gum or food; autoinflation via the Valsalva maneuver (forced exhalation with the mouth and nose closed) or a purpose-manufactured nasal balloon [27]

We suggest avoiding preflight treatment with antihistamines or decongestants in children. In a randomized trial, predeparture administration of pseudoephedrine did not decrease ear pain but was associated with increased drowsiness [28]. In addition, decongestants and antihistamines may delay the resolution of middle ear fluid and have been associated with increased adverse effects in young children [29-31]. (See "The common cold in children: Management and prevention", section on 'Over-the-counter medications'.)

ANTIBIOTIC THERAPY VERSUS OBSERVATION — Strategies for initial management of AOM in children include immediate treatment with antibiotics and initial observation with delayed initiation of antibiotic therapy if the symptoms and signs worsen or fail to improve after 48 to 72 hours. Immediate antibiotic therapy hastens symptom resolution and reduces the occurrence of treatment failure, but it increases the occurrence of antibiotic-related side effects (diarrhea, rash).

The choice of strategy depends upon the severity of illness, the age of the child, associated conditions, and caregiver preference. Our approach is largely in agreement with that of the American Academy of Pediatrics and American Academy of Family Physicians for children age 6 months to 12 years [1,32].

●Children at increased risk of severe infection, complications, and/or recurrent AOM – Patients at increased risk of severe infection, complications, and/or recurrence include:

•Infants <6 months of age

•Patients who are immunocompromised

•Patients who are toxic appearing

•Patients with craniofacial abnormalities (eg, cleft palate)

For these patients, we recommend immediate antibiotic therapy rather than initial observation. Although children in these groups generally were excluded from clinical trials, it is reasonable to expect that immediate antibiotic therapy would have similar effects and that the anticipated absolute benefit would be greater in these children than in lower-risk patients. (See 'Initial antibiotic therapy' below.)

●Children not at increased risk of severe infection, complications, and/or recurrent AOM – For most children not at increased risk of severe infection, complications, and/or recurrent AOM, we suggest immediate antibiotic therapy rather than initial observation.

In randomized trials, antibiotic therapy hastened symptom resolution and reduced the likelihood of treatment failure. However, the absolute benefits are modest and antibiotic-related side effects are common (eg, diarrhea, rash). Thus, some families may reasonably choose initial observation over antibiotic therapy, particularly if the child is ≥2 years old and has unilateral AOM without severe symptoms or otorrhea. Initial antibiotic therapy is more likely to be selected for patients <2 years old and those ≥2 years old with severe symptoms (eg, persistent ear pain for >48 hours, temperature ≥39°C in the past 48 hours), bilateral AOM, otorrhea, or uncertain follow-up. (See 'Initial antibiotic therapy' below and 'Initial observation' below.)

Evidence from several trials suggest that many children with AOM do well with initial observation or with delayed antibiotics and analgesia and that the outcomes are similar among children with AOM who are treated with immediate versus delayed antibiotics [9,11,33-35]. However, immediate antibiotic therapy is associated with earlier resolution of symptoms and otoscopic findings, reduced risk of tympanic membrane perforation, reduced occurrence of treatment failure, and fewer missed days of work for caregivers [36-42].

In a 2023 meta-analysis of 13 trials, immediate antibiotics compared with placebo reduced the proportion of children with ear pain at two to three days (12 versus 16 percent; risk ratio [RR] 0.71, 95% CI 0.58-0.88 [7 trials, 2320 children]) [9]. In addition, antibiotic treatment reduced the number of tympanic membrane perforations (2 versus 5 percent; RR 0.43, 95% CI 0.21-0.89 [5 trials, 1075 children]) and the development of contralateral AOM (11 versus 19 percent; RR 0.49, 95% CI 0.25-0.95 [4 trials, 906 children]). Antibiotics also increased the risk of vomiting, diarrhea, and rash (27 versus 20 percent; RR 1.38, 95% CI 1.16-1.63 [8 trials, 2107 children]).

Immediate antibiotic therapy may be more beneficial for certain subgroups of children. In a meta-analysis of individual patient data from six trials (1643 children age 6 months to 12 years), antibiotics were most beneficial for children with AOM and otorrhea and children younger than two years with bilateral AOM [6]. Children younger than two years of age with unilateral AOM also appear to benefit from antibiotic therapy. Pooled analysis of two randomized trials that used stringent diagnostic criteria [43,44] found increased rates of treatment failure among placebo recipients <24 months with unilateral, nonsevere AOM (40 versus 14 percent among antibiotic recipients; RR 0.34, 95% CI 0.18-0.65) [42]. Antibiotic therapy also reduced the rate of treatment failure in children with bilateral or severe (unilateral or bilateral) AOM (absolute risk reduction ranging from 31 to 34 percent), supporting the findings of earlier trials [6,45,46].

INITIAL ANTIBIOTIC THERAPY

Preferred regimens — Antibiotic therapy for AOM should include activity against the most common bacterial otopathogens: Streptococcus pneumoniae, nontypeable Haemophilus influenzae (NTHi), and Moraxella catarrhalis, and reflect current patterns of antimicrobial resistance. (See "Acute otitis media in children: Epidemiology, microbiology, and complications", section on 'Bacterial pathogens'.)

We suggest amoxicillin or amoxicillin-clavulanate as the initial agents, depending upon the risk of beta-lactamase-producing NTHi.

●Risk factors for beta-lactamase-producing NTHi – Risk factors for beta-lactamase-producing NTHi include:

•Receipt of a beta-lactam antibiotic in the previous 30 days

•Concomitant purulent conjunctivitis (which is usually caused by NTHi)

•History of recurrent AOM unresponsive to amoxicillin (NTHi is dominant in recurrent episodes)

•Living in a community with high uptake of pneumococcal conjugate vaccine (PCV) in children [47]; in the United States, this information is available from the Centers for Disease Control and Prevention [48]; in other countries, this information is available through the World Health Organization [49]

●Regimen for children without risk factors – For children with AOM without risk factors for beta-lactamase-producing NTHi, we prefer amoxicillin to other antibiotics (algorithm 1 and table 1).

•Because of the increased prevalence of penicillin-nonsusceptible S. pneumoniae in the United States, we use a dose of 90 mg/kg per day orally divided in two doses (we suggest a maximum of 3 g/day) [50,51].

•Lower doses of amoxicillin (eg, 40 mg/kg per day orally divided in two or three doses; maximum of 1.5 g/day) are appropriate in communities with low rates of penicillin-nonsusceptible S. pneumoniae.

●Regimen for children at increased risk for beta-lactamase-producing NTHi – For children with AOM at increased risk for beta-lactamase-producing NTHi, we prefer amoxicillin-clavulanate to other antibiotics (algorithm 1 and table 1) [52-55].

•In communities with increased prevalence of penicillin-resistant S. pneumoniae, we use a dose of 90 mg/kg per day of amoxicillin and 6.4 mg/kg per day of clavulanate orally divided in two doses (we suggest a maximum daily dose of the amoxicillin component of 3 g). Adolescents ≥16 years who can take large tablets can use extended-release amoxicillin-clavulanate 1 to 2 g of amoxicillin and 62.5 to 125 mg of clavulanate orally every 12 hours.

•Lower doses of the amoxicillin component (eg, 40 mg/kg of amoxicillin and 5.7 mg/kg of clavulanate orally divided in two doses) are appropriate in communities with lower rates of penicillin-nonsusceptible S. pneumoniae. However, the availability of amoxicillin-clavulanate formulations with this ratio (7:1) of amoxicillin to clavulanate varies geographically.

●Duration of treatment – We treat with amoxicillin or amoxicillin-clavulanate for:

•Ten days for children <2 years of age and children (of any age) with tympanic membrane perforation or history of recurrent AOM [56].

•Five to seven days for children ≥2 years with intact tympanic membrane and no history of recurrent AOM [57].

Although other agents have efficacy comparable to amoxicillin in randomized trials [34], we prefer amoxicillin for children at low risk for beta-lactamase-producing NTHi because it is effective, safe, relatively inexpensive, and has a narrow microbiologic spectrum [1,58-60]. Despite the increasing importance of NTHi (including beta-lactamase-producing strains) and M. catarrhalis as otopathogens in the post-PCV era [61], we continue to prefer high-dose amoxicillin to amoxicillin-clavulanate for children at low risk for beta-lactamase-producing NTHi because some children with NTHi AOM recover without antibiotics, gastrointestinal adverse effects (eg, diarrhea, disturbance of the microbiome) are more common with amoxicillin-clavulanate, and, in observational studies, clinical failure rates were similar with narrow and broad spectrum antibiotics [60,62-65]. Other experts suggest amoxicillin-clavulanate as the initial antibiotic for all children with AOM [64,66]. (See "Acute otitis media in children: Epidemiology, microbiology, and complications", section on 'Bacterial pathogens'.)

Using a dose of 90 mg/kg per day (high-dose) rather than 40 mg/kg per day (standard dose) increases the concentration of amoxicillin in the middle ear, which provides activity against most strains of S. pneumoniae with minimum inhibitory concentration (MIC) ≥2 and <4 to penicillin [67-69]. S. pneumoniae that are highly resistant to penicillin in the United States (ie, MIC ≥8 mcg/mL), which account for <2 percent of pneumococcal isolates, will not respond to high-dose amoxicillin [1,70,71]. Experience with strains with MIC >4 and <8 is limited.

High-dose amoxicillin also may be more effective than standard-dose amoxicillin against ampicillin-susceptible NTHi.

Continued monitoring of the microbiology of AOM is necessary to determine when and if a change in preferred therapy is necessary. The increasing prevalence of beta-lactamase-negative, ampicillin-resistant strains of H. influenzae in the community is a potential concern. These strains exhibit MICs for amoxicillin that may be at the upper limit of what is achievable in the middle ear. Such isolates remain uncommon in the United States but have become common in France and Japan [72,73]. (See "Acute otitis media in children: Epidemiology, microbiology, and complications", section on 'Bacterial pathogens'.)

We provide a 10-day course of antibiotics for children <2 years of age and children (of any age) with tympanic membrane perforation or history of recurrent AOM. In a randomized trial, the clinical failure rate was lower with 10 than with 5 days of treatment with high-dose amoxicillin-clavulanate for AOM in children age 6 through 23 months (16 versus 34 percent) [56]. Shorter courses are reasonable for children older than two years. In a meta-analysis of randomized trials in children age 1 month to 18 years, the clinical failure rate was only slightly lower with courses longer than seven days than with shorter courses (18 versus 21 percent), but longer courses were associated with increased rates of gastrointestinal adverse effects [57].

Alternative regimens — Acceptable alternatives to amoxicillin or amoxicillin-clavulanate for children with penicillin allergy or who cannot otherwise tolerate penicillin antibiotics depend upon the type of the previous reaction (table 2 and algorithm 2). Alternative regimens may provide less activity against the spectrum of common otopathogens.

Clinical features and diagnosis of immediate and delayed penicillin allergy are discussed separately. (See "Penicillin allergy: Immediate reactions" and "Allergy evaluation for immediate penicillin allergy: Skin test-based diagnostic strategies and cross-reactivity with other beta-lactam antibiotics" and "Penicillin allergy: Delayed hypersensitivity reactions".)

●Mild non-IgE-mediated reaction – Mild non-immunoglobulin E (IgE)-mediated reactions to penicillin typically appear after more than one dose (usually after days of treatment) and may be associated with a maculopapular or morbilliform eruption. They lack features of IgE-mediated reaction and serious delayed reactions (table 2). (See "Penicillin allergy: Delayed hypersensitivity reactions".)

For children with mild non-IgE-mediated reaction to penicillin antibiotics, we suggest one of the following (algorithm 1 and table 1):

•Oral cephalosporins – For oral cephalosporins, we treat for 10 days in children <2 years of age and children (of any age) with tympanic membrane perforation or recurrent AOM; we treat for 5 to 7 days in children ≥2 years of age with intact tympanic membrane and no history of recurrent AOM [56,57]. The availability of specific oral cephalosporins may vary regionally; appropriate alternatives (listed alphabetically) include:

-Cefdinir 14 mg/kg per day orally in one or two doses (maximum 600 mg/day)

-Cefpodoxime 10 mg/kg per day orally in two doses (maximum 400 mg/day)

-Cefuroxime suspension (no longer available in the United States) 30 mg/kg per day orally divided in two doses (maximum 1 g/day)

-Cefuroxime tablets 250 mg orally every 12 hours for children who weigh >17 kg and can swallow the tablet whole

The regimens above do not achieve sufficient concentration in the middle ear to eradicate penicillin-resistant S. pneumoniae and some penicillin-intermediate strains of S. pneumoniae. They have less activity against penicillin-resistant S. pneumoniae than amoxicillin or amoxicillin-clavulanate [74]. Cefuroxime has less activity against beta-lactamase-producing NTHi than amoxicillin-clavulanate [72].

•Ceftriaxone – Ceftriaxone 50 mg/kg intramuscularly (IM) once per day (maximum 1 g/day) for one to three doses (if there is symptomatic improvement within 48 hours of the first dose, additional doses are not necessary; if symptoms persist, a second and, if necessary, a third dose are administered [75]).

●IgE-mediated or serious delayed reaction – IgE-mediated reactions classically begin within one hour of the initial or last-administered dose; common features include anaphylaxis, angioedema, wheezing, laryngeal edema, hypotension, and hives/urticaria (table 2). Delayed reactions appear after multiple doses of treatment. Examples of serious delayed reactions include Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug-induced cytopenias (table 2) (See "Penicillin allergy: Immediate reactions" and "Penicillin allergy: Delayed hypersensitivity reactions".)

Alternatives to penicillin antibiotics for children with AOM and IgE-mediated or serious delayed reactions to penicillin or other beta-lactam antibiotics include macrolides (eg, azithromycin, clarithromycin) or lincosamide (eg, clindamycin) antibiotics (algorithm 1 and table 1). However, these agents generally are not effective for eradication of H. influenzae and approximately 25 to 35 percent of S. pneumoniae isolates are resistant to macrolide or lincosamide antibiotics [71,72,76,77].

The doses are as follows [78]:

•Azithromycin 10 mg/kg per day orally (maximum 500 mg/day) as a single dose on day 1 and 5 mg/kg per day (maximum 250 mg/day) for days 2 through 5

•Clarithromycin 15 mg/kg per day orally divided into two doses (maximum 1 g/day)

•Clindamycin 30 mg/kg per day orally divided into three doses (maximum 1.8 g/day)

For clarithromycin and clindamycin, we treat for 10 days in children <2 years of age and children (of any age) with tympanic membrane perforation or recurrent AOM and for 5 to 7 days in children with intact tympanic membrane and no history of recurrent AOM [56,57,79-82].

Trimethoprim-sulfamethoxazole (TMP-SMX) may be useful in regions where pneumococcal resistance to TMP-SMX is not a concern, but TMP-SMX should not be used if group A Streptococcus (GAS; Streptococcus pyogenes) is suspected (eg, when there is an associated otorrhea). Local pneumococcal susceptibility data may be obtained from state or local health departments or local hospitals. (See 'Tympanic membrane perforation' below.)

Special circumstances

Recurrent episode of AOM — A recurrent episode of AOM is defined by the development of signs and symptoms of AOM after completion of successful treatment. As with the initial episode of AOM, bulging of the tympanic membrane or other signs of inflammation is crucial to the diagnosis (picture 1). This avoids unnecessary provision of antibiotics to children with persistent middle ear effusion. (See 'Diagnosis of AOM' above.)

There are no randomized trials to guide treatment of recurrent episodes of AOM in children. Our approach is based upon the microbiology of recurrent AOM in children. Antibiotic therapy for recurrent episodes of AOM must include coverage for resistant S. pneumoniae, NTHi, and M. catarrhalis.

●Recurrence within 15 days of completion of antimicrobial therapy – When recurrence occurs within 15 days of completion of antimicrobial treatment for the previous episode, it is most often due to persistence of the original pathogen.

For children who were initially treated with amoxicillin, we prefer amoxicillin-clavulanate.

For children who were initially treated with an antibiotic other than amoxicillin, we suggest one of the following regimens:

•Ceftriaxone 50 mg/kg per day IM or intravenously (IV) for three days

•Ceftriaxone 50 mg/kg per dose IM or IV every 36 hours for a total of two doses (although this regimen has not been studied, it is suggested based on pharmacokinetics and middle ear drug levels)

Levofloxacin 10 mg/kg orally once per day (maximum 750 mg/day) for 10 days is an alternative for children ≥8 years of age, but is rarely used [83].

●Recurrence >15 days after completion of antimicrobial therapy – Recurrence >15 days after completion of treatment for the previous episode is most often due to a different pathogen than the previous episode. Recurrent AOM increases the likelihood of a pathogen nonsusceptible to amoxicillin.

Given the increased risk of amoxicillin nonsusceptibility, for children with recurrence >15 days after completion of antimicrobial therapy for a previous episode, we suggest treatment with high-dose amoxicillin-clavulanate, as described above. (See 'Preferred regimens' above.)

Tympanostomy tube insertion may be warranted for children with ≥3 distinct and well-documented episodes of AOM within 6 months or ≥4 episodes within 12 months if middle ear fluid is also present [84]. However, three strategies, tympanostomy tube insertion, antimicrobial prophylaxis, or episodic antimicrobial treatment, have similar outcomes [85]. (See "Acute otitis media in children: Prevention of recurrence", section on 'Tympanostomy tubes'.)

Evaluation of the immune system also may be warranted for children with ≥4 episodes of AOM within 12 months. However, if the spectrum of infection in the child is limited to recurrent AOM, a clinically concerning immune deficiency is unlikely. (See "Approach to the child with recurrent infections", section on 'Clinical features suggestive of a primary immunodeficiency'.)

Tympanic membrane perforation — For children with AOM and spontaneous tympanic membrane perforation, we suggest oral rather than topical antibiotic therapy. We prefer amoxicillin or amoxicillin-clavulanate to other oral agents. (See 'Preferred regimens' above.)

●Amoxicillin 90 mg/kg per day orally divided in two doses (we suggest a maximum of 3 g/day) for 10 days.

●Amoxicillin-clavulanate 90 mg/kg per day of amoxicillin and 6.4 mg/kg per day of clavulanate orally divided in two doses (we suggest a maximum daily dose of the amoxicillin component of 3 g) for 10 days. Adolescents ≥16 years who can take large tablets can use extended-release amoxicillin-clavulanate 1 to 2 g of amoxicillin and 62.5 to 125 mg of clavulanate orally every 12 hours.

For patients with acute otorrhea, 10 days of oral therapy is more effective than a shorter course [86].

Alternative agents for children with AOM and tympanic membrane perforation are the same as those for children without perforation, except that TMP-SMX should be avoided (given the frequency of GAS). (See 'Alternative regimens' above and "Acute otitis media in children: Epidemiology, microbiology, and complications", section on 'Group A Streptococcus'.)

Although topical therapy with quinolone otic drops (ofloxacin or ciprofloxacin) is equivalent to oral therapy for treatment of otorrhea in children with tympanostomy tubes or chronic suppurative otitis media [87,88], topical therapy has not been studied in children with AOM and acute perforation [87-89]. For children with AOM and spontaneous perforation, we prefer oral therapy because the spontaneous perforation may heal quickly, limiting access of topical therapy to the middle ear. (See "Tympanostomy tube otorrhea in children: Causes, prevention, and management", section on 'Treatment' and 'Tympanic membrane perforation' below.)

In a systematic review of 19 studies describing the microbiology of AOM with discharge due to spontaneous perforation of the tympanic membrane in the post-PCV era, bacteria were isolated in 76 percent [90]. S. pneumoniae (median 26 percent) and H. influenzae (median 19 percent) were isolated most frequently, followed by S. pyogenes and Staphylococcus aureus (median for each 12 percent). Whether isolation of S. aureus from discharge in the external canal reflects pathogenicity or commensal bacteria is uncertain. Changes in antimicrobial susceptibility over time were not detected, although information about susceptibility was limited and predominantly related to S. pneumoniae.

Additional aspects of the management of tympanic membrane perforation are discussed below. (See 'Tympanic membrane perforation' below.)

Otorrhea in children with tympanostomy tubes — The treatment of otorrhea in children with tympanostomy tubes is discussed separately. (See "Tympanostomy tube otorrhea in children: Causes, prevention, and management", section on 'Treatment'.)

AOM in cochlear implant recipient — Management of AOM in children with cochlear implants is discussed separately. (See "Cochlear implant infections", section on 'Management'.)

INITIAL OBSERVATION — When the initial observation strategy is chosen, caregivers must understand the risks and benefits, and appropriate follow-up must be ensured so that antibiotic therapy can be initiated if symptoms worsen or persist after 48 to 72 hours [1]. Unilateral AOM at first observation may rapidly progress to bilateral disease during the subsequent hours of illness.

Appropriate follow-up may include [37,38,91-94]:

●Caregiver-initiated visit or phone contact if symptoms worsen or do not improve at 48 to 72 hours

●A scheduled follow-up appointment in 48 to 72 hours

Specific indications for urgent follow-up (eg, signs of meningismus, cranial nerve palsy) should be provided to patients or caregivers and documented in the medical record. (See 'Response to antibiotics or observation' below.)

RESPONSE TO ANTIBIOTICS OR OBSERVATION

Persistent symptoms

●Initial observation – Children who worsen during observation or fail to improve after 48 to 72 hours of observation should be started on antibiotics. The child's status should be carefully reassessed in person (or by telehealth if the caregiver is well known to the clinician or office to determine if in-person re-evaluation is needed) before initiating antimicrobial treatment.

●Initial antibiotic therapy – Failure to improve or worsening after 48 to 72 hours of antibiotic therapy and analgesic therapy is considered treatment failure. Evaluation and management of treatment failure is discussed below. (See 'Treatment failure' below.)

Resolution of symptoms — Children whose symptoms have resolved should have follow-up to monitor the resolution of the associated middle ear effusion, which is associated with conductive hearing loss.

●For children <2 years of age and children ≥2 years of age with language or learning problems, we suggest follow-up otoscopy 8 to 12 weeks after diagnosis of AOM; for children ≤2 years, this timeframe may coincide with a previously scheduled health maintenance visit.

By 8 to 12 weeks after the diagnosis of AOM, the middle ear effusion will have resolved in 80 to 90 percent of children (figure 1). (See 'Clinical course without antibiotics' above.)

●For children ≥2 years without language or learning problems, we provide follow-up at the next health maintenance visit, or sooner if there are concerns regarding persistent hearing loss.

Although persistent middle ear fluid requires monitoring after resolution of symptoms, it is not an indication of treatment failure or an indication for additional antibiotic therapy [95]. (See "Otitis media with effusion (serous otitis media) in children: Management", section on 'Approach to management' and 'Clinical course without antibiotics' above.)

TREATMENT FAILURE — Worsening during, or failure to improve after, 48 to 72 hours of antibiotic therapy and analgesic therapy is considered treatment failure.

Etiology — Treatment failure suggests either:

●Development of a complication (see "Acute otitis media in children: Epidemiology, microbiology, and complications", section on 'Complications and sequelae' and 'Management of AOM complications' below)

●Initial antimicrobial therapy was inadequate

Although inadequate therapy is usually related to infection with an organism resistant to beta-lactam antibiotics (eg, nontypeable H. influenzae [NTHi], drug-resistant S. pneumoniae), infection with less common organisms, such as S. aureus, also must be considered, particularly in children with tympanostomy tubes or perforation [90,96-101]. (See "Acute otitis media in children: Epidemiology, microbiology, and complications", section on 'Microbiology'.)

●Another disease is present (see "Acute otitis media in children: Clinical manifestations and diagnosis", section on 'Differential diagnosis')

Changes to antibiotic regimen — Our approach to antimicrobial therapy for treatment failure varies with the initial agent, as described below.

●Initial amoxicillin – For children who fail initial treatment with high-dose amoxicillin, we prefer amoxicillin-clavulanate [1]:

•Amoxicillin-clavulanate 90 mg/kg per day amoxicillin and 6.4 mg/kg day of clavulanate orally divided in two doses (we suggest a maximum of 3 g/day). Adolescents ≥16 years who can take large tablets can use extended-release amoxicillin-clavulanate 1 to 2 g of the amoxicillin component and 62.5 to 125 mg of the clavulanate component every 12 hours.

We treat for 10 days in children <2 years of age and children (of any age) with tympanic membrane perforation or recurrent AOM; we treat for 5 to 7 days in children ≥2 years of age with intact tympanic membrane and no history of recurrent AOM [56,57].

We prefer amoxicillin-clavulanate for children who fail treatment with amoxicillin because of amoxicillin-clavulanate's efficacy against beta-lactamase-producing H. influenzae and M. catarrhalis; for S. pneumoniae, amoxicillin and amoxicillin-clavulanate have equivalent efficacy.

●Initial amoxicillin-clavulanate or oral cephalosporins – For children who fail initial treatment with high-dose amoxicillin-clavulanate or oral cephalosporins, we prefer parenteral ceftriaxone; oral levofloxacin is an alternative (algorithm 1 and table 1):

•Ceftriaxone 50 mg/kg intramuscularly or intravenously once per day (maximum 1g/day) for two or three doses.

Parenteral ceftriaxone 50 mg/kg achieves high levels in the middle ear and is effective for the treatment of AOM in children who fail amoxicillin [1]. An open-label prospective study suggested that three doses were superior to a single dose in eradicating penicillin-resistant S. pneumoniae from the middle ear [102].

•Levofloxacin

-Age 6 months to 5 years – 10 mg/kg orally every 12 hours for 10 days

-Age ≥5 years – 10 mg/kg per orally once daily (maximum 750 mg/day) for 10 days [83]

Levofloxacin should be reserved for children with contraindications to ceftriaxone or AOM refractory to other drugs (ideally it should only be used in children who have had serotype 19A isolated from the middle ear that is susceptible to levofloxacin) [96]. Levofloxacin resistance among S. pneumoniae respiratory isolates has been described in adults and rarely in children [103].

Trimethoprim-sulfamethoxazole (TMP-SMX), macrolides (eg, azithromycin, clarithromycin), and lincosamides (eg, clindamycin) are not recommended for AOM that fails to respond to treatment with high-dose amoxicillin or amoxicillin-clavulanate. Pneumococcal surveillance studies indicate that resistance to these agents is substantial [104,105]. Macrolides and lincosamides have limited activity against NTHi, which is a more likely pathogen among children who have failed initial amoxicillin therapy.

●Initial macrolides, clindamycin, or parenteral ceftriaxone or persistent treatment failure – Persistent treatment failure is defined by failure to improve after 48 to 72 hours of the second antibiotic.

For children who fail initial treatment with macrolides, clindamycin, or parenteral ceftriaxone and children with persistent treatment failure, we prefer tympanocentesis, if available, for culture and susceptibility of middle ear fluid to guide antimicrobial selection. Tympanocentesis will also provide relief of ear pain. A discussion of the tympanocentesis procedure is beyond the scope of this topic review but is available in the full text of reference [106]. Concomitant placement of a tympanostomy tube may be warranted. (See "Acute otitis media in children: Prevention of recurrence", section on 'Tympanostomy tubes'.)

If tympanocentesis is not available, switching to levofloxacin is reasonable [83]:

•Age 6 months to 5 years – 10 mg/kg orally every 12 hours for 10 days

•Age ≥5 years – 10 mg/kg per orally once daily (maximum 750 mg/day) for 10 days

Levofloxacin generally should be reserved for children with contraindications to ceftriaxone or AOM refractory to other drugs (ideally it should only be used in children who have had serotype 19A isolated from the middle ear that is susceptible to levofloxacin) [96].

The pathogens most likely in this scenario are multidrug-resistant S. pneumoniae or NTHi (either beta-lactamase positive or beta-lactamase negative). Most NTHi are susceptible to TMP-SMX, but susceptibility of S. pneumoniae varies geographically. TMP-SMX may be an option in areas with high rates of susceptibility.

Consultation with a pediatric infectious diseases expert and/or pediatric otolaryngologist may be warranted (algorithm 1 and table 1).

MANAGEMENT OF AOM COMPLICATIONS

Tympanic membrane perforation — Tympanic membrane perforation permits drainage of the middle ear abscess and relieves increased middle ear pressure. With the relief of middle ear pressure, the tympanic membrane usually heals quickly, sealing the perforation in hours to days. Antimicrobial therapy for children with tympanic membrane perforation is discussed above. (See 'Tympanic membrane perforation' above.)

Pain or persistent ear pain in a child with AOM and tympanic membrane perforation is unlikely to be due to AOM because the increased pressure in the middle is relieved with the perforation. Other causes of ear pain include:

●Extension of the infection to a contiguous space, such as the mastoid (ie, mastoiditis) (see "Acute mastoiditis in children: Clinical features and diagnosis", section on 'Diagnosis')

●Irritation of the external canal from middle ear drainage, resulting in otitis externa, in which case treatment with a topical quinolone may be beneficial (see "External otitis: Treatment", section on 'Topical otic preparations: General principles')

Nonantimicrobial topical agents, such as benzocaine or olive oil, should not be used to treat pain in patients with perforation of the tympanic membrane. These agents are not effective and may be harmful.

Patients with perforation that persists for three months or longer (with or without suppurative drainage) should be referred to an otolaryngologist for further management [107]. Prevention of chronic suppurative otitis media (CSOM) entails promptly treating AOM, given that CSOM frequently begins with an episode of AOM [108]. (See "Chronic suppurative otitis media (CSOM): Clinical features and diagnosis" and "Chronic suppurative otitis media (CSOM): Treatment, complications, and prevention".)

Other complications — The management of other intratemporal or intracranial complications of AOM is discussed separately:

●Cholesteatoma (see "Cholesteatoma in children", section on 'Surgical treatment')

●Mastoiditis, which may be complicated by petrositis (osteomyelitis of the petrous bone) (see "Acute mastoiditis in children: Treatment and prevention")

●Facial nerve palsy, which may be isolated or associated with osteomyelitis of the petrous bone (see "Facial nerve palsy in children", section on 'Treatment' and "Acute mastoiditis in children: Treatment and prevention", section on 'Complicated disease')

●Meningitis (see "Bacterial meningitis in children older than one month: Treatment and prognosis")

SOCIETY GUIDELINE LINKS — Links to society and government-sponsored guidelines from selected countries and regions around the world are provided separately. (See "Society guideline links: Acute otitis media, otitis media with effusion, and external otitis".)

INFORMATION FOR PATIENTS — UpToDate offers two types of patient education materials, "The Basics" and "Beyond the Basics." The Basics patient education pieces are written in plain language, at the 5^th to 6^th grade reading level, and they answer the four or five key questions a patient might have about a given condition. These articles are best for patients who want a general overview and who prefer short, easy-to-read materials. Beyond the Basics patient education pieces are longer, more sophisticated, and more detailed. These articles are written at the 10^th to 12^th grade reading level and are best for patients who want in-depth information and are comfortable with some medical jargon.

Here are the patient education articles that are relevant to this topic. We encourage you to print or email these topics to your patients. (You can also locate patient education articles on a variety of subjects by searching on "patient education" and the keyword[s] of interest.)

●Basics topics (see "Patient education: Ear infections in children (The Basics)" and "Patient education: Ruptured eardrum (The Basics)")

●Beyond the Basics topic (see "Patient education: Ear infections (otitis media) in children (Beyond the Basics)")

SUMMARY AND RECOMMENDATIONS

●Pain management – Pain management is a mainstay of treatment for AOM in children. For most patients, we suggest oral ibuprofen or acetaminophen rather than other analgesics (Grade 2C). Alternative analgesic agents for children ≥2 years of age without tympanic membrane perforation include topical procaine or lidocaine preparations (if available). (See 'Management of pain' above.)

●Immediate antibiotics versus observation – The choice of immediate treatment with antibiotics or observation depends upon the severity of illness, the age of the child, associated conditions, and caregiver preference (see 'Antibiotic therapy versus observation' above):

•Patients at increased risk of severe infection, complications, and/or recurrent AOM – Patients at increased risk of severe infection, complications, and/or recurrence include:

-Infants <6 months of age

-Patients who are immunocompromised

-Patients who are toxic appearing

-Patients with craniofacial abnormalities (eg, cleft palate)

For these patients, we recommend immediate antibiotic therapy rather than initial observation (Grade 1B). (See 'Initial antibiotic therapy' above.)

•Children not at increased risk of severe infection, complications, and/or recurrent AOM – For most children not at increased risk of severe infection, complications, and/or recurrent AOM, we suggest immediate antibiotic therapy rather than initial observation (Grade 2A).

In randomized trials, antibiotic therapy hastened symptom resolution and reduced the likelihood of treatment failure. However, the absolute benefits are modest and antibiotic-related side effects are common (eg, diarrhea, rash). Thus, some families may reasonably choose initial observation over antibiotic therapy, particularly if the child is ≥2 years old and has unilateral AOM without severe symptoms or otorrhea. Initial antibiotic therapy is more likely to be selected for patients <2 years old and those ≥2 years old with severe symptoms (eg, persistent ear pain for >48 hours, temperature ≥39°C in the past 48 hours), bilateral AOM, otorrhea, or uncertain follow-up. (See 'Initial antibiotic therapy' above and 'Initial observation' above.)

●Preferred regimens – Antibiotic therapy for AOM should include activity against the most common bacterial otopathogens: Streptococcus pneumoniae, nontypeable Haemophilus influenzae (NTHi), and Moraxella catarrhalis, considering changes in resistance patterns over time. (See "Acute otitis media in children: Epidemiology, microbiology, and complications", section on 'Bacterial pathogens'.)

When antibiotic treatment is warranted for the treatment of AOM in children, we suggest amoxicillin or amoxicillin-clavulanate rather than other antibiotics (Grade 2C); the choice between these agents depends upon the risk of beta-lactamase-producing NTHi. Alternative regimens (eg, oral, cefdinir, cefpodoxime, cefuroxime, azithromycin, clarithromycin, or clindamycin; intramuscular ceftriaxone) may provide less activity against the spectrum of common otopathogens (algorithm 1 and table 1). (See 'Preferred regimens' above and 'Alternative regimens' above.)

The dose for amoxicillin or amoxicillin-clavulanate depends upon the local prevalence of penicillin-nonsusceptible S. pneumoniae (table 1).

●Response to initial management

•Initial observation – Patients whose symptoms worsen or fail to improve after 48 to 72 hours of observation usually warrant antibiotics. (See 'Persistent symptoms' above and 'Preferred regimens' above.)

•Initial antibiotics – Worsening during, or failure to improve after, 48 to 72 hours of antibiotic therapy and analgesic therapy is considered treatment failure. Causes of treatment failure include development of a complication, inadequate initial antimicrobial therapy, or a condition other than AOM. (See 'Treatment failure' above and 'Management of AOM complications' above and "Acute otitis media in children: Clinical manifestations and diagnosis", section on 'Differential diagnosis'.)

ACKNOWLEDGMENT — The editorial staff at UpToDate acknowledge Jerome Klein, MD, who contributed to an earlier version of this topic review.