Acute otitis media: clinical guidelines

List of Abbreviations

PAOM – protracted acute otitis media;

CT – computed tomography;

NSAIDs – nonsteroidal anti-inflammatory drugs;

AOM – acute otitis media;

AOM – acute otitis media;

ARVI – acute respiratory viral infection;

rAOM – recurrent acute otitis media;

CSOM – chronic suppurative otitis media;

OME – otitis media with effusion.

Terms and Definitions

Acute otitis media is an inflammatory process involving all three parts of the middle ear: the tympanic cavity, mastoid cells, and auditory tube, manifesting with one or more characteristic symptoms (earache, fever, hearing loss, and in some cases, otorrhea). The pathological process involves only the mucous membrane of the specified cavities.

Recurrent acute otitis media is defined as the presence of three or more distinct episodes of AOM within 6 months, or 4 or more episodes within a 12-month period.

Persistent acute otitis media is defined as the presence of middle ear inflammation symptoms for 3–12 weeks following one or two courses of antibiotic therapy.

1. Brief information on the disease or condition

1.1 Definition of the disease or condition

Acute otitis media (AOM) is an inflammatory process involving all three parts of the middle ear: the tympanic cavity, mastoid cells, and auditory tube, manifesting with one or more characteristic symptoms (earache, fever, hearing loss, and in some cases, otorrhea).

AOM is a frequently occurring disease in both adult and pediatric practice. In the first three years of life, all children experience at least one episode of AOM, and in 50% of cases, the disease is recurrent [4, 7, 8].

In children, AOM may present with agitation, irritability, vomiting, and diarrhea. The disease typically lasts no more than three weeks; however, persistent or recurrent AOM may develop, potentially leading to permanent changes in the middle ear and hearing loss. A recurrent course of acute otitis media leads to chronic inflammatory middle ear pathology and progressive hearing loss, causing impaired speech development in prelingual children and delayed overall child development.

1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)

The primary etiological factor in the development of acute otitis media is the impact of a bacterial or viral agent on the middle ear mucosa, often against the background of altered body reactivity. In this context, the type of microorganism, its pathogenic properties, and virulence are of great importance.

At the same time, the anatomical and physiological characteristics of the middle ear structure in various age groups significantly influence the development and nature of the inflammatory process in the middle ear. These act as predisposing factors for the development of acute inflammation and its transition into a protracted and chronic course [1, 2, 3].

The main theories of the pathogenesis of acute otitis media explain its development by auditory tube dysfunction.

Impaired patency of the auditory tube leads to negative pressure in the tympanic cavity and the transudation of fluid, which is initially sterile. However, due to impaired mucociliary clearance of the middle ear and the influx of opportunistic facultatively anaerobic microflora from the nasopharynx, it becomes inflammatory in nature.

Thus, the main pathway of infection into the middle ear cavity is tubogenic—through the auditory tube. Other pathways of infection entering the tympanic cavity also exist: traumatic, and meningogenous—the retrograde spread of an infectious meningococcal inflammatory process through the labyrinthine aqueducts into the middle ear. Comparatively rarely, in infectious diseases (sepsis, scarlet fever, measles, tuberculosis, typhoid fever), a hematogenous pathway of infection spread to the middle ear occurs.

Under inflammatory conditions, exudate accumulates in the middle ear cavities, and its viscosity tends to increase in the absence of drainage.

In highly virulent infections, the tympanic membrane may be dissolved by pus enzymes. Through the perforation formed in the tympanic membrane, the discharge can evacuate from the tympanic cavity into the external auditory canal.

With low-virulence infections and other favorable conditions, perforation does not form, but exudate is retained in the tympanic cavity. In fact, the air space of the middle ear disappears. Under conditions of inflammation, impaired aeration, gas exchange, and middle ear drainage, irrational antibiotic therapy and immune disorders promote the transition of the acute process into sluggish inflammation of the middle ear mucosa (mucositis) and the development of chronic secretory otitis media [4, 5].

The main causative agents of acute otitis media are Streptococcus pneumoniae and Haemophilus influenzae, as well as Moraxella catarrhalis and Streptococcus pyogenes [1, 2, 3, 7]. Notably, there is a higher incidence of H. influenzae compared to acute bacterial sinusitis. Considering the biological properties inherent to S. pneumoniae (production of the main toxin, pneumolysin), pneumococcal infection is most characterized by a reactive clinical course with prominent main symptoms, frequently leading to AOM complications. Acute suppurative otitis media caused by S. pneumoniae typically does not tend to resolve spontaneously. Conversely, otitis media caused by Haemophilus influenzae is more frequently subclinical, lacking pronounced clinical symptoms while exerting a marked effect on the physiology and morphology of the ciliated epithelium via H. influenzae adhesins and endotoxin.

AOM caused by Streptococcus pyogenes is uncommon in pediatric practice (3–5%), developing rapidly with a pronounced clinical picture including high fever, rapidly occurring tympanic membrane perforation, and upper and lower respiratory tract manifestations [1, 2, 3, 14, 15, 16].

The role of Alloiococcus otitidis, which is more commonly found in children alongside Moraxella catarrhalis, is also under discussion. It must be remembered that Haemophilus influenzae and Moraxella are producers of β-lactamases, which neutralize the activity of broad-spectrum penicillins (ATC code: J01CA).

In younger age groups, gram-negative flora can be a significant pathogen. About 20% of cultures from the tympanic cavity are sterile. It is believed that up to 10% of AOM cases may be caused by viruses [4].

The spectrum of pathogens changes somewhat in persistent acute otitis media (PAOM) and recurrent acute otitis media (rAOM). Upon bacteriological examination of exudate 2 to 6 months after an episode of AOM, H. influenzae is detected in more than half of the cases (56–64%), while S. pneumoniae is found in only 5–29% of cases [6].

1.3 Epidemiology of the Disease or Condition

20–70% of respiratory infections in adults and children are complicated by the development of AOM. More than 35% of children in their first year of life experience AOM once or twice, and 7–8% experience it multiple times; under the age of 3, more than 65% of children experience AOM once or twice, and 35% experience it multiple times [7]. By the age of three, 71% of children have suffered from AOM.

Sensorineural hearing loss in adults is caused by a prior history of acute or chronic suppurative otitis media in 25.5% of cases [8].

1.4 Features of Coding the Disease or Condition

H65.0 – Acute serous otitis media

H65.1 – Other acute nonsuppurative otitis media

H66.0 – Acute suppurative otitis media

1.5 Classification of the disease or condition

Acute otitis media is a disease with distinct stages of progression. According to the classification by V.T. Palchunov et al. (1997), 5 stages of acute middle ear inflammation are distinguished [66]:

• Stage of acute eustachitis.

• Stage of catarrhal inflammation.

• Preperforative stage of suppurative inflammation.

• Postperforative stage of suppurative inflammation.

• Reparative stage.

By severity: AOM can be mild or severe (Table 1).

Table 1: Criteria for AOM severity.

1.6 Clinical presentation of the disease or condition

Key symptoms in the diagnosis of acute otitis media (AOM) in children over 2 years of age include acute onset of ear pain (otalgia) against the background of inflammatory changes in the tympanic membrane (hyperemia, bulging, decreased mobility on pneumatic otoscopy), and in the post-perforative stage of purulent inflammation, otorrhea (ear discharge) with the exclusion of external otitis, which is typically not accompanied by otalgia. Symptoms of systemic toxicity (fever, general malaise) are by no means observed in all patients with AOM. The primary rationale for diagnosis in infants and young children is otoscopic findings—primarily bulging of the tympanic membrane—and behavioral reactions (child's distress, feeding difficulties, pulling and rubbing the ear in unilateral cases). At the same time, AOM in young children is frequently diagnosed only when otorrhea is already present.

2. Diagnostics, medical indications and contraindications for diagnostic methods

Criteria for establishing the diagnosis/condition of AOM

Simultaneous presence of three signs of AOM in the patient:

• sudden onset of symptoms;

• signs of inflammation of the tympanic membrane (hyperemia, infiltration);

• signs of effusion in the tympanic cavity (bulging of the tympanic membrane,

• decreased compliance of the tympanic membrane on (pneumatic) otoscopy/tympanometry)

or sudden onset of otorrhea (excluding external otitis) as a consequence of spontaneous perforation of the tympanic membrane.

2.1 Complaints and Anamnesis

The main complaints are ear pain, fever, in some cases—ear discharge, hearing loss, and symptoms of an acute respiratory viral infection (ARVI). Adult patients more frequently complain of a feeling of fullness in the ear, autophony, and tinnitus.

Children, especially in younger age groups, extremely rarely present with complaints at this stage of AOM, as they cannot characterize their condition due to age. The medical history may indicate a recent acute respiratory viral infection (ARVI).

2.2 Physical Examination

Comments: a general physical examination is performed for all patients upon presentation to an otorhinolaryngologist in an outpatient setting, as well as upon admission of the patient to an inpatient otorhinolaryngology department.

Comments: according to the requirements for the development of clinical guidelines, it is necessary to indicate the strength of the recommendations and the evidence base in accordance with the scales for assessing the level of confidence of evidence (LCE) and the level of recommendation credibility (LRC), which for many recommendations will have a low level due to the lack of clinical studies dedicated to them. Despite this, they are necessary elements of patient examination for establishing a diagnosis and choosing treatment tactics.

The clinical picture of acute otitis media is based on symptoms characteristic of an acute inflammatory process (pain, fever, hyperemia of the tympanic membrane) and symptoms reflecting impaired function of the auditory (hearing) and, less frequently, vestibular (dizziness) receptors.

Hearing loss is characterized as conductive hearing loss; a sensorineural component may rarely join. Considering the pronounced staging of the course of AOM, it is advisable to give a clinical and diagnostic assessment of each stage.

Stage of acute eustachitis is characterized primarily by impaired function of the auditory tube, which triggers the further development of the pathological process.

Stage of acute catarrhal inflammation. On otoscopy: the tympanic membrane is hyperemic and thickened, landmarks are identified with difficulty or not identified at all.

Stage of acute purulent inflammation. This stage is caused by infection of the middle ear. Complaints: ear pain sharply increases. Symptoms of intoxication increase: the general condition worsens, and temperature reaches febrile levels.

Otoscopically, marked hyperemia of the tympanic membrane is determined, landmarks are not visible, and there is bulging of the tympanic membrane of varying severity. Due to the pressure of purulent secretion and its proteolytic activity, a perforation may appear in the tympanic membrane, through which pus is evacuated into the external auditory canal.

Post-perforative stage. Otoscopically, a perforation of the tympanic membrane is identified, from which purulent discharge flows into the external auditory canal.

Reparative stage. Patients practically have no complaints at this stage. Acute inflammation in the middle ear resolves. Otoscopy: restoration of the color and thickness of the tympanic membrane. The perforation most often heals with a scar. However, restoration of the mucosa of the middle ear cavities has not yet occurred.

2.3 Laboratory Diagnostics

Comments: The level of leukocytosis makes it possible to assess the likelihood of involvement of pathogenic bacterial microflora in the process.

Comments: The scheme by M.D. Bakradze (2009) (Table 2) makes it possible to differentiate the bacterial form of acute middle ear inflammation and determine drug management tactics.

Table 2. Markers of bacterial inflammation in otitis

Comments: Pathological discharge from the tympanic cavity is collected with a dry, sterile cotton swab. Afterwards, the material is placed, observing asepsis rules, into a test tube with transport nutrient medium and delivered to the bacteriological laboratory. Transport nutrient media must correspond in composition to the biological properties of etiologically significant microorganisms. The optimal delivery time for pathological material to the bacteriological laboratory is 40 minutes. When submitting pathological substrate for further molecular genetic studies (including for the verification of viral infections), as well as mass spectrometry, there is no need to use special transport nutrient media. At the same time, the amount of active pus in the studied material should be minimal due to the high content of proteolytic enzymes capable of lysing the genetic material of microorganisms.

2.4 Instrumental Diagnostics

Comments: decreased compliance of the tympanic membrane may indicate the presence of inflammatory effusion in the tympanic cavity.

2.5 Other Procedures

Not indicated.

3. Treatment, including drug and non-drug therapies, diet therapy, and pain management

Inpatient treatment in an otorhinolaryngology department is indicated for all patients with a severe course of AOM, as well as patients with an initially mild course of the disease in the absence of positive dynamics during adequate therapy or with progressive deterioration at any time.

3.1 Conservative Treatment

Comments: systemic dosage forms of nonsteroidal anti-inflammatory and antirheumatic drugs (ATC code: M01A) or anilide preparations (ATC code: N02BE) for AOM are used as a single dose if the patient complains of earache or if body temperature rises above 38.5°C (in patients with a history of febrile seizures, it is necessary to use drugs with an antipyretic effect (propionic acid derivatives, ATC code: M01AE, and anilides, ATC code: N02BE), at a body temperature of 38.0°C). If repeated administration is necessary, the frequency and interval between doses must comply with the drug's instructions for use.

In children with AOM under the age of 6 years, for the purpose of analgesia and fever management, it is possible to use only two drugs: paracetamol** (ATC code: N02BE01) up to 60 mg/kg/day (10–15 mg/kg/dose) or ibuprofen** (ATC code: M01AE01) up to 30 mg/kg/day (8–10 mg/kg/dose). Drug forms are prescribed taking into account the child's age: rectal suppositories are usually used in young children, or suspensions; film-coated tablets are more commonly used in children over 6 years of age. If oral administration and the use of rectal suppositories are not possible, parenteral administration of paracetamol** solution in a single dose calculated as 15 mg/kg may be used to achieve analgesia.

For clinical practice, a convenient classification exists according to which nonsteroidal anti-inflammatory and antirheumatic drugs (ATC code: M01A) are subdivided into medicinal products (MPs) with varying degrees of analgesic and anti-inflammatory activity:

• MPs with strong analgesic and mild anti-inflammatory action (metamizole sodium, paracetamol**, acetylsalicylic acid** at a dose up to 4 g/day);

• MPs with analgesic and moderately pronounced anti-inflammatory effect (propionic acid derivatives and fenamates);

• MPs with strong analgesic and pronounced anti-inflammatory properties (pyrazolones, acetic acid derivatives, oxicams, acetylsalicylic acid** at a daily dose of 4 g or more, and others).

In the management of pain in AOM, MPs with a predominant analgesic effect are more widely used [12,50].

In adult patients, ketoprofen** preparations (ATC code: M01AE03) can be used. Ketoprofen preparations where the active substance is in the form of ketoprofen lysine salt have certain pharmacological advantages [55-57].

To reduce pain and inflammation when nonsteroidal anti-inflammatory and antirheumatic drugs (ATC code: M01A) cannot be used, multi-component homeopathic remedies with a proven modulating effect on inflammatory mediators without COX-2 inhibition, registered in the territory of the Russian Federation, may be used [39-41,47,48].

Comments: For local analgesic therapy, it is advisable to use lidocaine + phenazone in the dosage form of ear drops (ATC code: S02DA30).

Comments: the prescription of systemic antibacterial therapy is necessary in case of clinical signs of AOM in children under two years of age, in the presence of convincing signs of suppurative AOM, in recurrent AOM, if clinical signs of the disease persist for 72 hours, and in patients with comorbid conditions predisposing to a higher risk of an unfavorable disease course. It is also advisable to consider prescribing systemic antibacterial therapy to patients who are unable to attend a follow-up appointment (examination, consultation) with an otorhinolaryngologist within 2-3 days from the initial examination (Table 3).

Table 3 – Indications for systemic antibacterial therapy in AOM in children

Comments: The physician must prescribe amoxicillin** for AOM if the patient has not taken it in the preceding 30 days, if purulent conjunctivitis is absent, and if there is no history of aminopenicillin intolerance (J01CA Broad-spectrum penicillins) in the past.

Local resistance patterns of leading pathogens must be taken into account. In case of a high risk of the patient carrying a pneumococcal strain with increased antibiotic resistance, it is advisable to use increased doses of amoxicillin** (ATC code: J01CA04): 80-90 mg/kg/day in children and 1000 mg 3 times a day in adults. However, in most regions of the Russian Federation, it is advisable to prescribe amoxicillin** at a "standard" dosage: 500-1000 mg 3 times a day in adults and children weighing over 40 kg, and at 45-60 mg/kg/day in children. The choice of drug formulation in children is made taking into account the child's age. In children under 3 years of age, only amoxicillin** (ATC code: J01CA04) in the form of a powder for oral suspension and dispersible tablets can be used. Film-coated tablets can only be used in children over 3 years of age, although this form is more commonly used in school-age children.

Comments: It is recommended in patients with AOM, in the absence of a sufficient clinical effect after three days, to switch from amoxicillin** (ATC code: J01CA04) to amoxicillin+[clavulanic acid]** (ATC code: J01CR02) or cefixime (ATC code: J01DD08) to target β-lactamase-producing strains of Haemophilus influenzae and Moraxella. The choice of the drug formulation in children is made taking into account the child's age. Amoxicillin+[clavulanic acid]** preparations (ATC code: J01CR02) and cefixime (ATC code: J01DD08) in film-coated tablet and capsule forms can only be prescribed in patients older than 12 years. In children under 12 years of age with a body weight of less than 40 kg, only preparations in the form of granules/powder for oral suspension or dispersible tablets can be prescribed.

In severe AOM in hospitalized patients, intramuscular and intravenous routes of antibiotic administration are preferred; third-generation cephalosporins (for parenteral administration) are indicated: cefotaxime** (ATC code: J01DD01) or ceftriaxone** (ATC code: J01DD04). If administered intravenously, Amoxicillin+Clavulanic Acid** (ATC code: J01CR02) can be used.

If the patient has a history of mild forms of penicillin intolerance (J01CA Broad-spectrum penicillins), third-generation cephalosporin preparations are advisable as drugs of choice: for outpatient practice – cefixime (ATC code: J01DD08); for inpatient patients requiring parenteral administration – ceftriaxone** (ATC code: J01DD04).

Currently, due to the increasing resistance of major pathogens causing purulent inflammation of the ENT organs to systemic antibacterial drugs (ATC code: J01), an increase in the single and daily dose of antibiotics for AOM in adults and children is required. The daily doses and administration regimens of antibiotics (ATC code: J01 Antibacterials for systemic use) in acute otitis media are presented in Table 4.

Table 4. Daily doses and administration regimens of antibiotics (ATC code: J01 Antibacterials for systemic use) in AOM

More rapid achievement and maintenance of a stable and high therapeutic concentration of the drug in the body is the key to preventing the development of antibiotic-resistant microorganism strains. The use of antibiotic formulations with higher bioavailability, which create high concentrations in the focus of infection—in particular, dispersible tablets—not only increases treatment efficacy but also reduces the risk of developing antibiotic resistance and the frequency of side effects (residual concentrations of clavulanic acid, etc.). The WHO, the international organization UNICEF, Eurasian clinical guidelines, and others draw attention to the need for their use [49, 50].

In a number of cases, based on the nature of the otitis media course or the presence of specific symptoms, one can presume the type of pathogen and select the optimal antibacterial drug [1, 2, 3, 5, 48].

• S. pneumoniae, if there is increasing otalgia and fever, and spontaneous perforation has occurred.

• Penicillin-resistant S. pneumoniae, if prior treatment was carried out with aminopenicillins (Beta-lactam antibacterials: penicillins; ATC code: J01C), macrolides, if antibiotic prophylaxis was performed, or if there is a history of recurrent acute otitis media (RAOM).

• The presence of S. pneumoniae is less likely if symptoms are mild and prior treatment was carried out with adequate doses of amoxicillin**.

• H. influenzae, if there is a combination of symptoms of otitis media and conjunctivitis.

• β-lactamase-producing H. influenzae or M. catarrhalis: if antibacterial therapy was administered within the preceding month; in case of ineffectiveness of a 3-day course of treatment with amoxicillin**; in a child who is frequently ill or attends daycare.

• The presence of H. influenzae is less likely if prior therapy was carried out with third-generation cephalosporins.

• Streptococcus pyogenes, if the disease develops rapidly with fever, spontaneous perforation of the tympanic membrane, otorrhea, and upper or lower respiratory tract symptoms.

Comments: macrolides are not the drugs of first choice due to the high resistance rate of S. pneumoniae (over 40%) and the lack of pronounced activity against H. influenzae.

The prescription of macrolides is possible only in case of intolerance to beta-lactam antibacterial drugs (ATC J01C, J01D) (IgE-mediated reactions) [49].

Comments: Preference should be given to oral forms of antibiotics. It should be borne in mind that in patients who have recently received courses of ampicillin** or amoxicillin**, there is a high probability of isolating beta-lactamase-producing microorganisms. For young children, in order to adequately adjust the dosage, systemic antibacterial drugs (ATC code: J01) are prescribed in the form of a suspension or dispersible tablets. Parenteral (intramuscular route of administration) is possible in case of a high risk of complications.

Comments: Longer courses of therapy are indicated for children under 2 years of age, children with otorrhea, and those with comorbid conditions. The timing of antibiotic therapy for PAOM and RAOM is determined individually and is usually longer (for oral administration – at least 14 days). It is considered that the course of systemic antibacterial therapy should not be completed until otorrhea has resolved.

The causes of antibiotic therapy failure in AOM, PAOM, and RAOM may include the following factors: inadequate antibiotic dosage, insufficient absorption, poor compliance, low drug concentration in the focus of inflammation.

Comments: These drugs have low activity against S. pneumoniae and/or H. influenzae and are not devoid of dangerous side effects (risk of Lyell's and Stevens-Johnson syndromes with  Sulfamethoxazole+Trimethoprim** (ATC code J01EE01) and ototoxicity with gentamicin** (ATC code J01GB03)).

Comments: Perforation of the tympanic membrane and the onset of suppuration significantly alter the clinical course of acute otitis media and require a corresponding adjustment in treatment tactics. Osmotically active ear drops containing an aminoglycoside and alcohol-containing drops should not be used due to the potential ototoxic effect.

There is a certain difference in the age restrictions for the use of ear drops based on fluoroquinolone antibiotics (ATC code: S02AA Anti-infectives). Norfloxacin-based ear drops (ATC code: S01AE02) may be used in children over 1 year of age, and ciprofloxacin**-based ear drops (ATC code: S01AX13) from 15 years of age. Ofloxacin**-based ear drops (ATC code: S01AX13) and dexamethasone ear drops in combination with anti-infectives (ATC code: S03CA01) are used in children over 1 year of age for acute purulent otitis media with an established tympanostomy tube.

Comments: Nasal forms of naphazoline (ATC code: R01AA08) have a pronounced toxic effect and should not be used in otorhinolaryngological practice. The use of naphazoline is the main cause of decongestant poisoning in children [59]. In children aged 0–6 years, phenylephrine (ATC code: R01AB01) 0.125%, oxymetazoline (ATC code: R01AB07) 0.01–0.025%, and xylometazoline** (ATC code: R01AB06) 0.05% (from 2 years of age) are used. In children over 1 year of age, a metered nasal spray dosage form should be preferred whenever possible. In children under 1 year of age, the only available nasal decongestant – alpha-adrenomimetic (ATC code: R01A Decongestants and other nasal preparations) dosage form is nasal drops.

Nasal decongestants—alpha-adrenomimetics (ATC code: R01A Decongestants and other nasal preparations) should be used in the treatment of patients with AOM, but strictly as prescribed and under a physician's supervision. Their use must be limited to 5–7 days due to the risk of rhinitis medicamentosa and systemic adverse effects [59].

Comments: Nasal irrigation 1–2 times a day with an isotonic sterile seawater solution (ATC code: R01AX10) helps reduce the severity of nasal symptoms and creates optimal conditions for subsequent topical drug administration. In preschool children, it is recommended to refrain from nasal irrigation with large volumes of solutions due to the high risk of middle ear infections as a consequence of these procedures.

Comments: In the treatment of AOM, an important objective is to improve mucociliary clearance of the tympanic cavity and the drainage function of the Eustachian tube. Impaired function of the ciliated epithelium of the upper respiratory tract and ear during respiratory diseases makes it difficult to evacuate pathological exudate from the tympanic cavity. The use of mucolytics in the early stages of the disease helps restore the function of the ciliated epithelium of the upper respiratory tract and ear more quickly and promotes mucociliary clearance of the middle ear.

It must be remembered that not every mucolytic drug (ATC code: R05CB), which has proven effective in bronchial pathology, can be used to treat AOM. Therefore, before prescribing a drug from this group, it is necessary to read the instructions for use and the registered indications specified therein.

Directly acting mucolytic drugs containing free SH groups are used, for example, acetylcysteine** (ATC code: R05CB01) in oral dosage forms (for children over 2 years of age, only in the form of an oral solution and granules for oral solution), as well as indirectly acting mucolytic drugs based on carbocisteine (ATC code: R05CB03). In children under 15 years of age, carbocisteine (ATC code: R05CB03) may be used only in syrup dosage form. Carbocisteine improves mucus drainage and restores normal physiological functions of the epithelium [53,54,58-60].

Certain pharmacological advantages are offered by carbocisteine preparations with the active substance in the form of lysine monohydrate. The addition of lysine to the carbocisteine molecule positively affects mucus properties and reduces gastrointestinal adverse events [27,50].

3.2 Surgical Treatment

Comments: Paracentesis is performed exclusively by an otorhinolaryngologist when indicated. Paracentesis is indicated for pronounced clinical symptoms (earache, fever) and otoscopic findings (bulging, infiltration of the tympanic membrane) in the non-perforative form of AOM. Paracentesis is indicated for patients with pain that is not relieved by nonsteroidal anti-inflammatory and antirheumatic drugs (ATC code: M01A) or when the effect of these drugs is short-lived. Paracentesis must be performed in patients who show no positive dynamics in the severity of AOM symptoms and/or general intoxication symptoms within 48–72 hours after the initiation of systemic antibacterial therapy.

Performing paracentesis against the background of systemic antibacterial therapy can be considered as first aid for patients with signs of intratemporal and, to a lesser extent, intracranial complications, although in such cases it only buys a little time to prepare the patient for sanitizing surgery (antromastoidectomy).

In all questionable situations in AOM ("to do or not to do"), the decision should be made in favor of performing paracentesis.

Comments: emergency surgical intervention (antromastoidectomy) is performed in a hospital setting under general anesthesia.

[1] In the absence of risk factors for pneumococcal resistance to beta-lactams (use of antibiotics in the preceding 3 months, presence of preschool children in the family attending childcare facilities, children and adults living in "closed" institutions).

[2] In the presence of risk factors for pneumococcal resistance to beta-lactams (use of antibiotics in the preceding 3 months, presence of preschool children in the family attending childcare facilities, children and adults living in "closed" institutions).

[3] Risk factors for the presence of a beta-lactamase-producing pathogen strain (H. influenzae, S. aureus, M. catarrhalis), presence of concomitant diseases (comorbid pathology: bronchial asthma, diabetes mellitus, chronic bronchitis, etc.), immunosuppressive states, previous unsuccessful antibacterial therapy with amoxicillin**.

[4] At high risk of complications.

4. Medical Rehabilitation and Sanatorium-Resort Treatment

In some cases, the reparative stage of AOM requires therapeutic otorhinolaryngological manipulations aimed at restoring aeration and gas exchange in the middle ear cavities.

Comments: The actions of the otorhinolaryngologist should be aimed at restoring hearing and aeration of the middle ear cavities, since at this stage there is a high risk of the acute condition transitioning into a chronic disease, especially in children with recurrent otitis media. The restoration of middle ear cavity aeration should be confirmed by objective examination methods, including tympanometry.

5. Prevention and Dispensary Observation

After the clinical manifestations of AOM subside, patients should be monitored by an otorhinolaryngologist, especially children with a recurrent or protracted course of AOM. In the post-perforative stage of AOM, dynamic monitoring of the patient is necessary to assess the restoration of the integrity of the tympanic membrane and middle ear aeration using otomicroscopy (video-otoscopy, examination of the tympanic membrane using a microscope); audiological examinations (tympanometry) are advisable.

Medical prevention

Comments: vaccination against pneumococcus with a 7-, 10-, or 13-valent conjugate vaccine significantly reduces the risk of AOM in children during the first 5 years of life. At the same time, there is insufficient evidence of the efficacy of pneumococcal vaccination in children with recurrent AOM. Pneumococcal vaccination in children older than one year is pathogenetically justified, but also lacks a sufficient evidence base. Nontypeable strains of Haemophilus influenzae play an important role in the etiology of AOM, against which there are currently no vaccines [68, 69].

Non-medicinal prevention

6. Organization of Medical Care

Medical care is organized in accordance with the Patient Management Algorithm (Appendix B).

Indications for patient hospitalization: emergency hospitalization is indicated for all patients with a severe course of AOM, as well as for patients with an initially mild course of the disease if there is no positive trend against the background of adequate therapy within 3-5 days or in case of progressive deterioration at any time.

Indications for patient discharge: a patient with AOM may be discharged from the inpatient otorhinolaryngology department upon achieving a stable satisfactory condition for at least the last 3 days.

7. Additional Information

A more severe course and a high risk of complications should be expected in patients with primary and secondary immunodeficiencies and diabetes mellitus. The risk of developing AOM increases in patients with GERD and allergic rhinitis, smokers, and individuals regularly exposed to passive smoking [46].

Criteria for Evaluating the Quality of Medical Care

Criteria for assessing the quality of primary health care for adults and children with acute middle ear infection

Criteria for assessing the quality of specialized medical care for adults and children with acute middle ear infection

References

Appendix A1. Working Group Composition

1. Karneeva O.V., MD, DSc, Associate Professor, Member of the National Medical Association of Otorhinolaryngologists, no conflict of interest.

2. Yunusov A.S., MD, DSc, Professor, Member of the National Medical Association of Otorhinolaryngologists, no conflict of interest.

3. Gurov A.V., MD, DSc, Professor, Member of the National Medical Association of Otorhinolaryngologists, no conflict of interest.

4. Polyakov D.P., PhD, Member of the National Medical Association of Otorhinolaryngologists, no conflict of interest.

5. Ryazantsev S.V., MD, DSc, Professor, Member of the National Medical Association of Otorhinolaryngologists, no conflict of interest.

6. Geppe N.A., MD, DSc, Professor, no conflict of interest.

7. Tulupov D.A., PhD, Associate Professor, Member of the National Medical Association of Otorhinolaryngologists, no conflict of interest.

8. Dzhamaludinov Yu.A., MD, DSc, Professor, Member of the National Medical Association of Otorhinolaryngologists, no conflict of interest.

Appendix A2. Methodology for Developing Clinical Guidelines

The methodology for developing clinical guidelines is based on a comprehensive analysis of the current state of the problem, literature data, and regulatory legal acts, followed by discussion within the professional community and amendments based on the results of resolutions of conferences and national congresses, provided they are approved by the Ministry of Health.

These clinical guidelines summarize the authors' experience in the diagnosis and treatment of patients with acute sinusitis. The clinical guidelines contain information necessary for the diagnosis, differential diagnosis, and selection of treatment methods for patients with acute sinusitis.

Target audience for these clinical guidelines:

1. Otorhinolaryngologists (in accordance with Order of the Russian Ministry of Health No. 205n dated May 2, 2023 (as amended on December 4, 2023) "On Approval of the Nomenclature of Positions of Medical Workers and Pharmaceutical Workers" (Registered with the Ministry of Justice of Russia on June 1, 2023, No. 73664))

2. General practitioners, pediatricians (in accordance with Order of the Russian Ministry of Health No. 205n dated May 2, 2023 (as amended on December 4, 2023) "On Approval of the Nomenclature of Positions of Medical Workers and Pharmaceutical Workers" (Registered with the Ministry of Justice of Russia on June 1, 2023, No. 73664))

Table A1. Levels of Evidence (LoE) grading scale for diagnostic methods (diagnostic interventions)

Table А2. Level of Evidence (LoE) rating scale for prevention, treatment, and rehabilitation methods (preventive, therapeutic, and rehabilitative interventions)

Table А3. Grading system for levels of convincing evidence (LCE) for preventive, diagnostic, treatment, and rehabilitation methods (interventions)

Procedure for updating clinical guidelines.

The update mechanism for clinical guidelines provides for their systematic revision—at least once every three years, as well as upon the emergence of new evidence-based data regarding the diagnosis, treatment, prevention, and rehabilitation of specific conditions, or in the presence of justified additions/comments to previously approved clinical guidelines, but no more frequently than once every 6 months.

Appendix A3. Reference Materials

Order of the Ministry of Health of the Russian Federation No. 905n dated November 12, 2012, "On Approval of the Procedure for Providing Medical Care to the Population in the Specialty 'Otorhinolaryngology'."

Appendix B. Physician Action Algorithms

Appendix C. Patient Information

Earache, febrile fever, hearing loss, and sometimes otorrhea are signs of acute otitis media (AOM). This disease not only reduces the patient's quality of life but also increases the risk of life-threatening intralabyrinthine and intracranial complications. Timely seeking of qualified care and adequate treatment of this disease prevent hearing loss and complications.

The patient must be examined by an otolaryngologist for diagnosis and the prescription of adequate, timely therapy, including antibacterial treatment. When indicated, as determined by the otolaryngologist (preperforative stage of AOM), surgical intervention (paracentesis) is necessary.

Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools

To date, Russian otolaryngological practice does not use any specific scales or questionnaires in the diagnosis and management of patients with AOM.