There was ample heterogeneity in the consulted literature, as vaccines and vaccine coverages, microbiological tests, diagnostic criteria, clinical forms and recommended treatments varied based on the countries where studies were conducted. Still, most authors agreed on three points regarding vaccination with PCV-133–8:

• 1

  The vaccine has had a larger than expected impact in the prevention of AOM and the decrease in the prevalence of nasopharyngeal carriage of vaccine serotypes, with the exception of 19A (a smaller reduction in the number of cases).

• 2

  It has resulted in shifts in the aetiology of both diseases. At present, nontypeable Haemophilus influenzae (NTHi) and Streptococcus pneumoniae are the predominant causative agents of AOM in healthy children, with frequency distributions that vary between studies. In many studies, NTHi was the leading cause of AOM. In the case of pneumococcus, there has also been an increase in the proportion of cases caused by nonvaccine serotypes. Moraxella catarrhalis continues to be the third most frequent causative agent, with an increased proportion of cases caused by this agent compared to the pre-vaccine period (partly explained by molecular detection techniques).

• 3

  There has not been a significant decrease in the relative frequency of penicillin resistance in Streptococcus pneumoniae, which remains at 15%–30% depending on the publication, on account of the emergence of nonvaccine serotypes. In Spain, most of these strains belong to serotypes 23B, 24F, 14 and 11A, associated with clonal complex 156.

Acute otitis media belongs to a spectrum of diseases that involve the middle ear (ME) and with different definitions (Table 2).9,10 The diagnosis is usually based on the clinical presentation, as the routine use of the gold standard (tympanocentesis) would not be justified. The specificity of symptoms decreases the younger the patient (Table 3),11 and changes in the tympanic membrane (TM) are difficult to distinguish and interpret in some cases (Table 4).12,13 Recent systematic reviews and clinical guidelines recommend the application of more precise diagnostic criteria (Table 5) and consider the examination of the TM indispensable.9,11,12 Bulging evinces the presence of exudate, especially if the TM is opacified and its mobility impaired, and it is considered the most characteristic finding of bacterial AOM.12 The concepts of “uncertain” or “probable” diagnosis should be avoided, and repetition of the examination in 48 h is a preferred approach.10,13 The severity is established based on the characteristics of the patient and the clinical presentation (Table 6).9

Pneumatic otoscopy can evince impairment or near absence of mobility in the eardrum due to space occupation, which occurs both in AOM and in otitis media with effusion (OME).14,15 In some cases, these 2 entities may be considered different stages of the same disease, which is classified as AOM if it presents with manifestations of acute infection, and has implications for clinical care.16

As of 2013, the American Academy of Pediatrics assigned the evidence in support of the recommendation to use pneumatic otoscopy a grade B quality, although there were expert clinicians that did not consider it necessary, and there is evidence of a lower sensitivity and specificity when performed by inexperienced examiners.16,17 In 2018, the international consensus (ICON) on management of otitis media with effusion in children published by Simon et al. recommended the use of pneumatic otoscopy in the diagnosis of OME (grade A evidence).18 The 2022 update of the clinical practice guideline on tympanostomy tubes in children published by Rosenfeld et al. states that pneumatic otoscopy is the method of choice when there are doubts regarding the presence of effusion in the middle ear.19

The diagnosis of sinusitis is still based on the clinical presentation; the features suggestive of a bacterial aetiology are cough and nasal discharge lasting longer than 10 days in the context of upper respiratory tract infection, fever greater than 39 °C and purulent nasal discharge lasting 3–4 days.

Sinus puncture and aspiration is the only method that allows certain aetiological diagnosis, but its use is only indicated in select cases; it should be contemplated carefully in patients with septic appearance, intracranial complications, immunosuppression, recurrent sinusitis or who do not respond to the customary antibiotic treatment.20 Although some authors propose culture of middle meatal fluid specimens obtained by endoscopy as an alternative to sinus puncture and aspiration, this procedure is not useful in the paediatric age group because the meatus is usually colonised by pathogenic bacteria even in asymptomatic children.20

Nasopharyngeal samples are not an adequate alternative either: there is no correlation with the results obtained in sinus aspiration samples, and negative results in nasopharyngeal samples do not rule out the presence of sinusitis.21

At present, the sole indication for imaging tests in patients with sinusitis is the suspicion of complications. Table 7 summarises the characteristics of the different imaging tests along with their advantages and disadvantages, and the recommendations regarding their use can be found at the end of this text.22,24

Pain is the main symptom of AOM and ineffective pain management is associated with an increase in antibiotic consumption, repeat visits and failure of the watchful waiting approach.25 The management of AOM should always include appropriate analgesia, and the agent of choice is paracetamol or ibuprofen, administered orally at doses and intervals appropriate for the patient’s age and weight.26 There is no evidence of any difference in efficacy or adverse events between these two drugs, and alternating the two is not recommended based on the Cochrane systematic review published in 2016.27

Myringotomy, historically considered a treatment option for poorly controlled pain, does not play this role now. In addition to its technical difficulty and the risks it carries, it has been demonstrated to be less effective in alleviating pain than oral analgesia.26

In recent years, evidence has emerged on the potential benefits of topical anaesthetics (ear drops): systematic reviews have provided limited evidence on their use, and they are contraindicated in the case of eardrum perforation.28 One of the aspects that supports their use is that it may increase the success of delayed prescribing strategies, thus reducing the use of antibiotics and their systemic effects.29

Approximately 80% of cases of AOM resolve spontaneously. For this reason, immediate antibiotic prescribing would only be indicated in the following cases: age less than 6 months, otorrhoea, bilateral AOM, severe unilateral AOM (Table 6), immunosuppression or circumstances precluding adequate followup.1,30,31

In recent years, a growing number of publications have addressed delayed prescribing in the management of uncomplicated respiratory infections in children. They usually compare 3 groups of patients in relation to the use of antibiotics: immediate prescribing, delayed prescribing and no prescribing.32–34

In children aged more than 6 months in good general health presenting with ear pain, the literature supports prescription of analgesia and delaying initiation of antibiotherapy for 48–72 h with adequate outpatient followup (watchful waiting) as long as the onset of ear occurred in the past 48 h.16,34 In children aged 6–24 months, this “wait and see” approach has been found to fail more frequently on account of a longer duration of symptoms, with increased health care costs and time off work in families, although without an increased risk of complications.33,34

The delayed prescribing strategy can be contemplated in children aged more than 6 months, without severe or bilateral AOM and without otorrhoea, after educating the family about warning signs, offering to initiate antibiotherapy if they detect worsening of symptoms despite analgesia (thus, this strategy depends on the reliability and vigilance of caregivers). This strategy has been found to reduce antibiotic consumption by up to 30%–50% in studies conducted in Spain, without an associated increase in the duration of symptoms or the incidence of complications.32

Acute sinusitis resolves spontaneously in 60%–80% of cases.2 The consensus document published in 2013 recommended restricting the initiation of antibiotherapy to select cases (persistence of symptoms or evident clinical worsening).2 The guidelines of the American Academy of Pediatrics propose the same criteria, adding the possibility of watchful waiting even in the case of upper respiratory symptoms of more than 10 days’ duration, with the consent of the family or caregivers and excluding patients with underlying disease.33

Some studies have found no differences in the frequency of resolution or the development of complications independently of the clinical severity at diagnosis,32 while others have found some differences.33 In any case, the delayed prescribing and no prescribing strategies always require close clinical monitoring of the patient to watch for the development of potential complications.34

In European AOM guidelines, 82% of countries recommend amoxicillin as the first-line agent for empiric antibiotherapy, of which 50% recommend high-dose antibiotherapy (80−90 mg/kg/day given in 2 or 3 doses up to a maximum of 3 g/day).10,31 Due to the emergence of nonvaccine serotypes with decreased susceptibility to penicillin documented in studies conducted after the introduction of the PCV-13, prescription of the standard dose is an alternative not currently recommended.35–37 If the presentation is severe, there are risk factors or infection by H influenzae is suspected (age < 6 months, incomplete vaccination, association with purulent conjunctivitis, recurrence, antibiotherapy in the past 30 days), amoxicillin-clavulanic acid should be prescribed at a 8:1 ratio (dosage: 80−90 mg amoxicillin/kg/day given in 2 or 3 doses).1,38 The use of amoxicillin without clavulanic acid outside of these exceptional cases has not been associated with an increase in adverse events, complications or treatment failure.39

Recent studies demonstrate that the use of short courses of antibiotherapy is not associated with an increased frequency of treatment failure or complications in the management of paediatric infections at the outpatient level while it is associated with a decreased incidence of adverse events.40,41 A clinical trial conducted by Hoberman et al. (2016) compared courses of 5 vs 10 days of amoxicillin/clavulanic acid in patients aged 6–23 months, concluding that the shortened course was associated with a higher frequency of clinical failure. However, clinical failure rates were higher in patients with greater exposure to the pathogen, more severe disease and less favourable characteristics at onset independently of the treatment group they were allocated to, which suggests that clinical failure was more strongly associated with individual factors.42 A study on the implementation of clinical practice guidelines conducted in Italy in 2019 (ProBA project) found that the 5-day course of antibiotherapy for treatment of AOM was not associated with an increased incidence of mastoiditis, but was associated with a reduction in antibiotic use and adverse events.43 As concerns acute sinusitis, a meta-analysis published in 2009 did not find evidence of increased complications in patients with acute uncomplicated sinusitis treated with a short course (5–6 days) versus standard course (10 days) of antibiotherapy44; although at the time of this writing, there is no evidence on the subject from clinical trials.

In patients allergic to amoxicillin, the alternative antibiotic agent should match to the extent possible the efficacy and spectrum of the first-line drug. Table 8 presents the available alternatives, which should also be selected based on the type of hypersensitivity reaction (IgE-mediated or not) and its severity.16,45,46 In the case of non-IgE-mediated reactions, if the allergy is not due to the β-lactam ring, consider treatment with a cephalosporin with a different R side chain to those present in aminopenicillins: the drug of choice would be cefuroxime axetil (avoiding cefadroxil and cefaclor) and, should it fail, ceftriaxone administered intramuscularly. The selection and administration will take place under the supervision of the department of allergy, as long as the skin allergy tests are negative, and with close monitoring of the patient. The risk of cross-reactivity is estimated at approximately 0.1%–0.5%.16,46

The most frequently used preventive strategies are watchful waiting, antibiotic prophylaxis and surgery. Other evidence-based measures routinely recommended are breastfeeding, avoidance of tobacco smoke, avoidance of pacifiers/binkies in infants aged more than 6 months, health education regarding the risks of early attendance to nurseries, vaccination against pneumococcal and annual vaccination against seasonal influenza. There is not sufficient evidence to recommend supplementation with probiotics, oligosaccharides, xylitol or vitamin D.47

• 1

  Watchful waiting/wait and see: close observation or antibiotic treatment in each episode of AOM. This strategy is particularly recommended in children aged more than 2 years, on account of the decreased frequency of AOM episodes due to the maturity of the immune system and anatomical changes in the Eustachian tube.

• 2

  Antibiotic prophylaxis: it can reduce the frequency of episodes, although the protective effect does not endure after it is discontinued and it can cause diarrhoea, allergic reactions and selective pressure contributing to antimicrobial resistance.48 It must be reserve for very select cases, chiefly children aged less than 2 years with anaesthetic/surgical risk, predisposing anatomical features, immunosuppression or carrying hearing aids.21 The most frequently used drug is amoxicillin, given in a single dose of 20 mg/kg/day, although a dose of up to 40 mg/kg/day may be used in areas with a high prevalence of resistant pneumococcus. In Spain, routine prophylaxis with macrolides or cotrimoxazole is not appropriate given the resistance of pneumococcus to these antibiotics. Prophylaxis has to be administered daily, especially in winter, preferably for periods not exceeding 6 months.

• 3

  Surgery: it is the standard of care if prophylaxis fails or is refused, in patients allergic to amoxicillin or in the case of persistent OME (especially if it is associated with a functional impairment in language or progressive hearing loss).47,49,50 The usual approach is myringotomy and placement of a tympanostomy tube (TT). There is no clear evidence that this intervention achieves a reduction in the number of episodes of recurrent AOM, although it does prolong the time elapsed to the first recurrence and achieves a reduction in the use of antibiotics (decreased severity and duration of episodes); otorrhoea frequently develops after surgery, although it is possible to use topical antibiotherapy in the form of eardrops. The drawbacks of TTs include the possibility of permanent perforation of the tympanic membrane, tympanosclerosis, focal atrophy and cholesteatoma.47 Adenoidectomy, with or without tonsillectomy, does not seem to be effective in preventing recurrent AOM, and should only be considered at the outset if there are symptoms directly related to adenoid enlargement or when the TT needs to be reinserted due to new episodes of recurrent AOM in children aged more than 2 years (some studies have found evidence suggestive of a decrease in the frequency of hospital admission and TT reinsertion).19,47