External Otitis: Clinical Guidelines

List of Abbreviations

MEO — Malignant (necrotizing) external otitis

EAC — external auditory canal

EO — external otitis

Terms and Definitions

External otitis (EO) is inflammation of the auricle, external auditory canal, and the epidermal layer of the tympanic membrane

1. Brief information on the disease or condition

1.1 Definition of the disease or condition

External otitis (EO) is inflammation of the auricle, external auditory canal, and the epidermal layer of the tympanic membrane

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

The development of an inflammatory process in the external ear is preceded by a breach of the skin integrity, which can be caused by many factors—traumatic injuries, prolonged exposure to a humid environment, skin alterations associated with metabolic disorders, diabetes mellitus, various dermatitis types, and eczematous processes. Predisposing factors for otitis externa include anatomical features of the structure, such as narrow external auditory canals, the presence of exostoses, as well as wearing hearing aids, headphones, water getting into the ears, insufficient production or altered composition of earwax, impaired local and systemic immune status, and radiation exposure [1,2,3,4,5,6,7,8].

Normally, the external auditory canal (EAC) is colonized by various microorganisms, 90% of which are gram-positive bacteria.

According to literature, inflammatory diseases of the external ear are of bacterial nature in 60-98% of cases.

The most common bacterial pathogens influencing the development of the external ear inflammatory process in children include P. aeruginosa,

S. aureus, P. vulgaris and E. coli. [9, 10]. Leading positions among the listed pathogens are occupied by Pseudomonas aeruginosa and Staphylococcus aureus, while the isolation rate of the Pseudomonas aeruginosa strain can reach 20 to 60%, and the Staphylococcus aureus strain from 10 to 70% [10, 11, 12]. The incidence of anaerobic strains is 4-25% [13]. Mixed flora is found in one-third of cases [15,16].

Fungal infection plays a significant role among the causative agents of otitis externa. Epidemiological data on the prevalence of fungal otitis externa among the pediatric population are heterogeneous and differ significantly across various climate zones. A number of studies confirm a significantly higher incidence in countries with tropical and subtropical climates. The most important pathogenetic factors influencing the development of the mycotic process in the external ear include a history of skin trauma, metabolic and hormonal imbalances, immunodeficient states, prolonged use of systemic antibacterial drugs and dermatological corticosteroids (ATC code D07) / glucocorticoids (ATC code H02AB).

Fungal otitis externa in children is not a rare pathology. According to foreign authors, the frequency of fungal etiology is about 10% [10]; according to domestic studies, the proportion of fungal lesions of the external auditory canal among external ear pathologies in children in Russia is higher and may exceed 20% [17].

Modern data analysis on the etiology of fungal otitis externa in children shows that the main causative agents of this disease are molds of the genus Aspergillus, Penicillium, as well as yeast-like fungi of the genus Candida. [13, 17, 18, 19, 20]

In the presence of clinical manifestations of fungal lesions of the external auditory canal, microbiological studies frequently isolate fungal-bacterial associations. Pseudomonas aeruginosa, streptococcal, and staphylococcal microflora are the most common pathogens in mixed infections [20].

1.3 Epidemiology of the Disease or Condition

Otitis externa (OE) can be observed in all age groups. According to US population data, otitis externa occurs with a frequency of 1:123, with slightly less than half of the cases occurring in children aged 5-14 years. The approximate lifetime probability of developing otitis externa is 10% [21].

Contributing to the growth of this pathology are irrational treatment of acute inflammatory conditions (excessive use of systemic antibacterial drugs), increasing flora resistance levels, an increasing number of individuals with metabolic disorders, altered immune status including allergic conditions, delayed consultation with an otorhinolaryngologist, and other reasons such as wearing headphones, earplugs, and hearing aids [21,22].

OE is more common in summer compared to winter months [22,23]. This may be due to high ambient humidity and children swimming in rivers, ponds, pools, and the sea. It is known that the disease is most prevalent among swimmers and divers, and is also most frequently observed in countries with humid and hot climates.

1.4 Features of Coding the Disease or Condition

Otitis externa (H60); Other disorders of external ear (H61); Disorders of external ear in diseases classified elsewhere (H62):

H60.0 – Abscess of external ear;

H60.1 – Cellulitis of external ear;

H60.2 – Malignant otitis externa;

H60.3 – Other infectious otitis externa;

H60.5 – Acute noninfective otitis externa;

H60.8 – Other otitis externa;

H60.9 – Otitis externa, unspecified;

H61.0 – Perichondritis of external ear;

H61.8 – Other specified disorders of external ear;

H61.9 – Disorder of external ear, unspecified;

H62.0 – Otitis externa in bacterial diseases classified elsewhere;

H62.1 – Otitis externa in viral diseases classified elsewhere;

H62.2 – Otitis externa in mycoses;

H62.3 – Otitis externa in other infectious and parasitic diseases classified elsewhere;

H62.4 – Otitis externa in other diseases classified elsewhere;

H62.8 – Other disorders of external ear in diseases classified elsewhere.

1.5 Classification of the disease or condition

Various forms of otitis externa differ in etiology, pathogenesis, clinical manifestations, and disease duration.

In otorhinolaryngology, acute (up to 6 weeks) and chronic (when symptoms of otitis externa persist for more than 3 months or in the presence of more than 4 episodes of otitis externa per year) forms of otitis externa are most commonly distinguished [8].

Nosological forms of OE include: diffuse otitis externa, localized otitis externa (furuncle, abscess), eczema and dermatitis, erysipelas, perichondritis, herpetic infection, fungal otitis externa, and malignant otitis externa.

Malignant otitis externa is the most severe form of external ear disease. Characteristic features of this form of inflammation include a rapid, progressive course with the spread of the pathological process not only to the auricle and ear canal, but also beyond the structures of the external ear.

1.6 Clinical presentation of the disease or condition

Diffuse inflammation of the external auditory canal.

According to the clinical course, acute and chronic forms of the disease are distinguished.

The acute form of inflammation is characterized by the following otoscopic signs:

– Edema and hyperemia of the skin of the external auditory canal, discharge of viscous secretions;

– The tympanic membrane may be obscured due to pronounced skin edema of the canal walls in both the cartilaginous and bony parts;

– Accumulation of detritus in the external auditory canal;

General and local symptoms include:

– Tenderness in the area of the external auditory canal, which increases with traction (pulling) of the auricle or pressure on the tragus;

– Possible increase in body temperature to febrile levels;

– Pain and restricted movement in the temporomandibular joint area (when opening the mouth);

– Enlargement and tenderness of retroauricular lymph nodes (resembling the picture of acute mastoiditis, "pseudomastoiditis").

– The chronic inflammation phase is most characteristically marked by the following otoscopic signs:

– Thickening of the skin due to infiltration or fibrosis, signs of myringitis.

*Conductive hearing loss is detected with significant narrowing of the external auditory canal lumen or its obstruction by pathological discharge.

Localized otitis externa (furuncle)

Otoscopic signs of a furuncle of the auditory canal:

– Narrowing of the lumen of the auditory canal due to a defined conical or rounded elevation with local skin hyperemia.

– The infiltration stage is characterized by localized induration of the auditory canal skin (days 1–3 of the disease), while the abscess formation stage is characterized by more pronounced local signs of inflammation with visualization of a purulent head shining through the skin.

– Spontaneous rupture of the furuncle reveals a crater-like depression in the area of the elevation on the wall of the auditory canal with the presence of purulent discharge.

General and local symptoms include:

– Earache that increases with traction (pulling) of the auricle or pressure on the tragus;

– Irradiation of pain localized to the teeth, eye, neck, parotid space, pharynx.

– Possible spread of skin infiltration of the external auditory canal to the surrounding soft tissues, mastoid process, and eyelids.

– When the furuncle is localized on the posterior wall of the auditory canal, coughing and vomiting may occur (due to irritation of the branches of the vagus nerve) [25].

– Inflammation of the parotid gland when the furuncle is localized on the anterior or inferior wall of the auditory canal.

– Enlargement, induration, and tenderness upon palpation of regional lymph nodes.

– Possible increase in body temperature to febrile levels.

– Conductive hearing loss is detected in cases of significant narrowing of the external auditory canal.

Eczema and dermatitis of the external ear

Otoscopic signs of acute eczema:

– Hyperemia and infiltration of the skin of the auricle and external auditory canal.

– Vesicular-pustular rash on an erythematous, edematous base with weeping. Presence of grayish-yellow crusts.

– General and local symptoms include:

– Marked local itching on the side of the affected ear

* Secondary infection causes the development of localized or diffuse external otitis.

Chronic eczema of the external ear is characterized by the spread of the process deeper into the skin. Clinical manifestations are less pronounced. The main manifestations of chronic eczema include: itching, skin thickening, scaling, fissures, and weeping.

Erysipelas of the external ear

General and local symptoms include:

– Marked hyperemia and swelling of the skin of the auricle (including the lobule), with the inflammation spreading beyond the auricle with a demarcation line.

– Burning sensation and sharp pain on palpation.

– Symptoms of general intoxication (chills, headache), fever up to 39–40 °C.

Presence of vesicles with serous contents in the bullous form.

Perichondritis of the auricle

General and local symptoms include:

– Severe pain in the auricle area (does not involve the earlobe), possibly radiating to the head or neck.

– Edema and hyperemia of the auricle, smoothed contours (the inflammatory process does not involve the earlobe).

– Marked tenderness of the auricle upon palpation.

– As the disease progresses, purulent exudate forms between the perichondrium and the cartilage of the auricle, and fluctuation appears.

– Symptoms of general intoxication.

* Late presentation leads to cartilage melting, rejection of necrotic tissue, formation of fistulous tracts, which subsequently results in cicatricial deformity of the auricle.

Herpes zoster oticus (Herpetic infection of the external ear)

General and local symptoms include:

– Multiple vesicular elements grouped in the auricle and external auditory canal, with possible localization on the tympanic membrane. Crusts form after spontaneous rupture of the vesicles.

– Sharp ear pain, tingling, itching.

– Symptoms of general intoxication are possible

– In severe cases, hearing impairment (sensorineural hearing loss), balance disorders, and facial and trigeminal nerve paralysis are possible.

Fungal infection of the external ear

Clinical manifestations of auditory canal involvement largely depend on the genus and species of the causative fungus

– In infants and toddlers, characteristic clinical manifestations of external otomycosis include: restlessness, pendular head movements, and scratching of the skin in the auricle area.

– Older children may complain of liquid discharge from the ear (in candidiasis), crust formation, itching, pain, a feeling of fullness, and hearing loss. Complaints of hearing loss or ear fullness are caused by impaired sound conduction due to infiltration of the external auditory canal walls and the presence of pathological fungal discharge in the canal lumen. In rare cases, children may complain of headache, fever, and increased sensitivity of the auricle and retroauricular region.

– In mycosis caused by Candida strains, the skin of the auricle and perauricular region may be involved in the inflammatory process. Candidal infection of the external ear is characterized by: hyperemia, infiltration, and maceration of the skin of the external auditory canal, and hyperemia of the tympanic membrane. Discharge on the walls of the auditory canal is less thick, unlike inflammation caused by mold fungi. The color of the discharge has a whitish tint. When the inflammation spreads to the auricle, skin hyperemia with erosions is detected, granulations and scales are possible, and whitish deposits on the skin of the auricle are easily removed. Involvement of the auricle in the inflammatory process can cause chondroperichondritis with subsequent deformation of the auricle.

– In external otitis caused by mold fungi of the genus Aspergillus, the clinical picture is specific. Caseous-necrotic masses are determined in the lumen of the auditory canal, skin infiltration of the external auditory canal is more pronounced in the bony part, and signs of myringitis are possible. Deposits on the walls of the auditory canal are grayish-white with black inclusions resembling "ground pepper". When the auditory canal is affected by Aspergillus glaucus, the pathological discharge has a specific greenish tint.

– When the external ear is affected by mold fungi of the genus Penicillium, the clinical manifestations are also specific. The color of the discharge has a yellowish tint, in some cases resembling earwax. The skin of the auditory canal is infiltrated, and pathological discharge is detected throughout the auditory canal. Additional elements on the skin of the auditory canal may include dry crusts and films.

– For geotrichosis of the auditory canal caused by the strain (Geotrichum capitatum), characteristic clinical manifestations are: marked infiltration of the skin of the external auditory canal, and signs of myringitis. Dense "putty-like" grayish-yellow fungal masses are determined in the lumen of the auditory canal. Pathological discharge is detected throughout the auditory canal.

Malignant (necrotizing) external otitis is quite rare in pediatrics, but can be observed in immunocompromised patients (including children with leukemias after bone marrow transplantation). This condition typically presents with more intense ear pain, headache on the affected side, systemic signs (intoxication or fever), and possibly temporal bone tenderness or facial nerve palsy. Granulation tissue at the osteocartilaginous junction of the floor of the external auditory canal is a classic sign of malignant external otitis. The infection spreads through the fascial planes of the cartilaginous part of the external auditory canal to the skull base, contributing to temporal bone osteomyelitis [8,26].

2. Diagnostics, medical indications and contraindications for diagnostic methods

Diagnosis of external otitis is based on history, physical examination, including examination of the hearing organ (otoscopy) (see sections "Clinical Presentation", "Complaints and History", "Physical Examination").

Diagnostic criteria for external otitis:

Signs and symptoms of auditory canal inflammation (tender tragus and/or auricle) or diffuse edema or hyperemia of the auditory canal,

Possible signs: otorrhea, regional adenopathy, erythema of the tympanic membrane or cellulitis of the auricle and adjacent skin, ear pain sometimes radiating to the jaw, itching, or a feeling of fullness in the ear.

[4, 30, 49].

Other examination methods are necessary for choosing treatment tactics and/or diagnosing complications, as well as for follow-up monitoring.

2.1 Complaints and Anamnesis

The most common symptoms of external otitis are:

- ear pain (may increase with palpation and chewing).

- itching in the external auditory canal

- ear discharge

- hearing loss

Systemic manifestations;

- fever (in the vast majority of cases, low-grade body temperature);

- deterioration of general well-being (phenomena of infectious toxicosis).

2.2 Physical Examination

During the examination, attention should be paid to sensitivity or pain when pressing on the tragus and pulling the auricle to examine the external auditory canal, as well as to the condition of the skin.

Comments: Otoscopy is of decisive importance both in diagnosis and differential diagnosis. During otoscopy, the external auditory canal is hyperemic, usually narrowed due to soft tissue edema.

The tympanic membrane may be only partially visible due to edema of the external auditory canal. Nevertheless, moderate hyperemia of the tympanic membrane can be observed. Performing an examination of the hearing organ (otoscopy) with simultaneous air insufflation into the ear cavity (otopneumoscopy) makes it possible to assess the mobility of the tympanic membrane, which in external otitis is generally preserved.

2.3 Laboratory Diagnostics

Comments: Conditions for sampling material for bacteriological examination:

o prior to the initiation of antimicrobial therapy;

o under visual control; material is obtained from the lumen or walls of the external auditory canal using a thin swab (single-use sterile medical swab), avoiding contact with the distal parts of the external ear.

The choice of method for determining the antimicrobial susceptibility of microorganisms is carried out in accordance with established practice.

If monitoring is necessary and/or there is no clinical response, the examination may be repeated.

Comment: a complete blood count (CBC) with differential and serum C-reactive protein (CRP) level should be performed in all hospitalized patients, including those with malignant otitis externa, to assess the inflammatory process.

2.4 Instrumental Diagnostics

Comments: destructive changes of the temporal bone and skull base (except in malignant otitis externa) are not characteristic.

• If there is a suspicion of the inflammatory process spreading to surrounding soft tissues, selective magnetic resonance imaging (MRI) of bone tissue (one region) (MRI of the temporal bones) or MRI of the skull base is recommended to further clarify the diagnosis, extent of inflammation, and treatment strategy [22, 27].

LeR CLoE 5Level of Recommendation C (Level of Evidence — 5)

Comments: general anesthesia as clinically indicated.

2.5 Other Procedures

2.5.1 Differential Diagnosis

Comments: for example, consultation with a pediatric oncologist, infectious disease specialist, allergist-immunologist, pediatric endocrinologist, neurologist, dermatovenereologist, etc., according to clinical necessity.

Comments: The diagnosis of OE should be questioned if the patient has a perforated tympanic membrane. It is likely that the primary focus of the disease in this case is the middle ear with secondary inflammation of the EAC.

When performing differential diagnosis with mastoiditis, attention is drawn to the smoothing of the retroauricular crease, with changes predominantly affecting the retroauricular region and the projection area of the mastoid antrum; temporal bone radiography or CT reveals decreased pneumatization, as well as disruption of the structure and integrity of the bone framework of the mastoid air cells.

It is essential to differentiate otitis externa from its malignant form.

Malignant otitis externa is characterized by a number of features, including:

o granulation tissue in the auditory canal;

o microabscesses in the external ear and skull base region;

o presence of bone destruction on imaging studies;

o lack of positive response to conservative therapy for more than one week

Exacerbating factors in the course of OE:

o diabetes mellitus;

o cranial nerve neuropathies;

o cachexia;

o Inability to perform diagnostic imaging.

The lack of positive dynamics with conservative treatment within 1–3 weeks points towards malignant otitis externa [8, 33].

The diagnosis is confirmed using diagnostic imaging (computed tomography or magnetic resonance imaging: computed tomography of the temporal bone, computed tomography of the temporal bone with intravenous bolus contrast enhancement, magnetic resonance imaging of the skull base, magnetic resonance imaging of the skull base with angiography) indicating skull base osteomyelitis, as well as (additionally) in the presence of inflammatory markers (neutrophilic leukocytosis, elevated C-reactive protein level) [33].

Differential diagnosis should also be made with purulent parotitis, which is characterized by swelling and tenderness inferior and anterior to the external auditory canal (in the projection area of the parotid salivary gland), combined with profuse otorrhea if a salivary gland abscess ruptures through the fissures of Santorini into the EAC.

In otomycosis (inflammation caused by a fungal infection), coatings and deposits are present on the skin of the external auditory canal. Specifically, dark coal-dust-like deposits or deposits resembling wet newspaper may indicate Aspergillus niger as the causative agent; whitish flakes are typically associated with Candida albicans. Excessive moisture and microtrauma of the external auditory canal predispose to otomycosis. Otomycosis may occur as an independent disease or as a complication of antibacterial therapy. The diagnosis is confirmed by microbiological examination.

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

3.1. Conservative management

Comments: according to literature data, no statistically significant difference in treatment outcomes was found between two groups of patients, one of which received local treatment combined with systemic antibacterial therapy, while the other received topical medications and placebo.

Comments: When prescribing systemic antibacterial drugs for otitis externa, it is necessary to take into account their potential activity against P. aeruginosa and S. aureus [8]. Currently, there is insufficient evidence regarding the treatment of malignant otitis externa. Pending microbiological test results, therapy should be initiated with agents effective against P. aeruginosa, as it is the leading pathogen in patients with malignant otitis externa [35]. Systemic antibacterial drugs are administered orally (#ciprofloxacin**) at a dose of 20-30 mg/kg/day, divided into 2 doses at 12-hour intervals (maximum dose 1500 mg/day), or parenterally in an equivalent dosage (beta-lactam antibacterials, penicillins [with antipseudomonal activity], third-generation cephalosporins, or fourth-generation cephalosporins [with antipseudomonal activity], with or without aminoglycosides) in accordance with the susceptibility data of the isolated pathogen (given the widespread use of #ciprofloxacin** in outpatient practice, many strains of P. aeruginosa have acquired resistance). Based on microbiological test results (see section 2.3) or data suggesting a different etiology of malignant otitis externa (e.g., Enterobacterales spp. or Aspergillus spp. [less commonly, other molds], methicillin-resistant Staphylococcus aureus [MRSA], Enterobacterales spp.), appropriate systemic antimicrobial drugs are used. The course of therapy is 4-6-8 weeks. In fungal etiology, the course may be longer, e.g., up to 12 weeks [36]. Concurrently, topical therapy for otitis externa is prescribed (drugs for ear diseases: antimicrobials, corticosteroids, corticosteroids in combination with antimicrobials, analgesics, and anesthetics) (see Table 1); traditional antiseptics and iodine preparations may be used [8, 37].

If the disease is progressive and/or responds poorly to conservative therapy, surgical treatment is performed (see section "Surgical treatment"), potentially combined with hyperbaric oxygen therapy for ear diseases.

During the treatment of malignant otitis externa, clinical symptoms and radiological findings should be regularly monitored to assess treatment response and timely diagnose recurrence (computed tomography of the temporal bone and/or computed tomography of the temporal bone with intravenous bolus contrast enhancement and/or magnetic resonance imaging of bone tissue [single region] (magnetic resonance imaging of the temporal bone) and/or magnetic resonance imaging of the skull base). Follow-up microbiological testing of ear discharge is also performed (microbiological [culture] examination of purulent discharge for aerobic and facultative anaerobic microorganisms, determination of microorganism susceptibility to antimicrobial chemotherapeutic agents by the disk-diffusion method, determination of microorganism susceptibility to antimicrobial chemotherapeutic agents by dilution methods, determination of microorganism susceptibility to antimicrobial chemotherapeutic agents using automated analyzers, microscopic examination of ear discharge for fungi [yeast and mycelial], microbiological [culture] examination of ear discharge for yeast fungi, microbiological [culture] examination of ear discharge for mycelial fungi, microscopic examination of skin scrapings for fungi [yeast, molds, dermatophytes], microbiological [culture] examination of wound discharge for fungi [yeast, mycelial]) (see section 2.3). The frequency of examinations is determined individually [8].

Comments: see Table 1

The advantages of topical therapy for otitis externa are the direct action and creation of an optimal drug concentration at the inflammation site, the practical absence of systemic effects due to low drug absorption, and a lower risk of selecting resistant microflora strains [21, 41]

Considering the spectrum of main pathogens of acute diffuse otitis externa, the drugs used must be effective against Pseudomonas aeruginosa and Staphylococcus aureus. The effectiveness of the ongoing therapy is evaluated within 48-72 hours. The duration of treatment averages 7-10 days (up to 14 days).

Both single-ingredient drugs and combination products are used—combinations of various antimicrobials, corticosteroids, corticosteroids in combination with antimicrobials, analgesics, and anesthetics. The drugs listed below are indicated as initial topical therapy for uncomplicated otitis externa due to their safety and efficacy. Complications practically do not occur compared to the use of systemic drugs [18, 21, 22].

If otitis externa is a manifestation of contact dermatitis / atopic dermatitis / seborrheic dermatitis / psoriasis / systemic lupus erythematosus, therapy according to the relevant clinical guidelines is required.

At the same time, it should be borne in mind that in patients with seborrheic dermatitis, otitis externa may be a consequence of Malassezia fungal infection, which requires the inclusion of topical therapy with antifungal and/or anti-inflammatory effects [12, 22].

It should also be noted that allergic reactions to topical treatment of otitis externa are possible, including from drugs containing neomycin (ATC codes: S02 otologicals and S02CA06 dexamethasone and anti-infectives in combination) [21].

Table 1. Drugs for topical treatment of ear diseases used in pediatric practice in the treatment of otitis externa (based on [40] with modifications) [40, 42]

¹In case of a perforated tympanic membrane (regarded as a systemic (invasive) infection), a systemic antifungal agent should be prescribed based on microbiological test results, for example, fluconazole** (for candidal otitis externa), itraconazole (for otitis externa caused by Aspergillus spp.), or another agent depending on local resistance data [8]. The drugs are prescribed taking into account the age restrictions specified in the instructions.

²clotrimazole is not active against Aspergillus spp.

³ course of therapy for at least 10 days

Comment: see section "Etiology and Pathogenesis"

Comment: systemic therapy is used, for example, ibuprofen** or paracetamol** in age-appropriate dosages, and/or topical therapy. Ibuprofen suspension can be used in children starting from 3 months of age, whereas paracetamol has restrictions for use in younger children.

Since local anesthesia may mask the progression of external otitis, patients prescribed such treatment must be monitored for 48 hours [8].

Comments: Care of the external auditory canal (cleaning of the auditory canal) must be atraumatic and consists in the removal of cerumen and exudate.

The presence of exudate (often with microbial toxins) limits or neutralizes the effectiveness of local treatment.

Toilet of the external auditory canal is usually performed by an otorhinolaryngologist.

After excluding a tympanic membrane defect, the ear canal can be gently irrigated with distilled water or sodium chloride** (0.9% solution).

Patients should not clean their ears with cotton swabs, as microtraumas contribute to bacterial invasion.

Toilet of the external auditory canal in otomycosis:

To conduct effective local antifungal therapy, a prerequisite is to perform a thorough toilet of the external auditory canal from pathological discharge. Toilet of the infected ear (care of the external auditory canal) is performed using a surgical probe (attic probe) and a cotton applicator treated with a topical antifungal drug.

In the treatment of candidal external otitis in children, a 1% clotrimazole solution or 1% naftifine solution is used.

1% clotrimazole solution is used for the care of the external auditory canal and for applications on turundas (administration of drugs into the external auditory canal) with a frequency of 2 times a day with an exposure of up to 10 minutes. The average duration of the treatment course is 4 weeks.

In external otitis caused by mold and dimorphic fungi, a 1% naftifine solution is used for local antifungal therapy. As with candidal inflammation, the drug is used both for the toilet of the external auditory canal and in the form of applications on turundas with a frequency of 2 times a day with an exposure of up to 15 minutes. The average course of therapy is 4 weeks.

3.2. Surgical treatment

Comments: performed by an otorhinolaryngologist with the participation of an anesthesiologist-resuscitologist

3.3. Other treatment

Comments: currently, there is no convincing evidence regarding physiotherapeutic treatment methods for external otitis. They are used only as adjunctive therapy.

4. Medical Rehabilitation and Sanatorium-Resort Treatment

Not required.

5. Prevention and Dispensary Observation

5.1. Prevention

Comments: Recently, children and adolescents are increasingly using headphones almost every day and may share headphones with other children. Children with hearing impairment use hearing aids with ear molds.

Headphones, ear molds (for hearing aids), and earplugs (earplug inserts) should be periodically treated with antiseptic solutions. Use only your personal headphones, molds (ear molds for hearing aids), and earplugs (earplug inserts).

The time of headphone use should be limited, as prolonged wearing can injure the EAC.

Cotton swabs should not be used because they can injure the EAC.

The use of rigid earplugs (reusable earplugs) for the ears should be avoided, as they can also injure the EAC.

The external auditory canal should be dried after water ingress, including by using a hair dryer.

5.2. Dispensary follow-up

Not required.

6. Organization of Medical Care

Treatment in most cases is carried out on an outpatient basis. Improvement of the condition after the initiation of antibacterial therapy for bacterial external otitis is observed within 12-24 hours.

Children in severe condition require hospitalization.

Treatment failure, suspicion of the progression of the inflammatory process, and the development of complications are indications for consultation by an otorhinolaryngologist, for malignant external otitis – an otorhinolaryngologist (if necessary, a pediatric oncologists and other specialists) and hospitalization.

Discharge from the hospital is carried out with stable relief of disease manifestations and the absence of a threat to the patient's life and health.

6.1 Complications

Lack of treatment or inadequate treatment of external otitis is fraught with a high probability of developing serious complications:

o Transformation of acute external otitis into a chronic form. The infectious and inflammatory process passes into a "dormant" state, to be activated thereafter every time in the presence of unfavorable factors.

o Destruction of the cartilaginous and bony tissues of the external auditory canal. Spread of the process to adjacent tissues and organs.

7. Additional Information

7.1 Outcomes and prognosis

The prognosis of external otitis is favorable in most cases.

Criteria for Evaluating the Quality of Medical Care

Table 1 Criteria for assessing the quality of specialized medical care for children with external otitis

References

Appendix A1. Working Group Composition

Baranov A.A., Academician of the RAS, Professor, MD; Honorary President of the Union of Pediatrists of Russia, Advisor to the Head of the Research Institute of Pediatrics and Child Health of the National Medical Research Center No. 2 of the Petrovsky National Research Centre of Surgery, Professor at the Department of Pediatrics and Pediatric Rheumatology of the Sechenov First Moscow State Medical University (Sechenov University) of the Ministry of Health of Russia, Chief freelance pediatric specialist of the Ministry of Health of Russia

Kozlov R.S., Corresponding Member of the RAS, Professor, MD, Rector of the Smolensk State Medical University of the Ministry of Health of Russia, Chief freelance specialist of the Ministry of Health of Russia in Clinical Microbiology and Antimicrobial Resistance, President of ISCMR

Namazova-Baranova L.S., Academician of the RAS, Professor, MD, President of the Union of Pediatrists of Russia; Past-President of EPA/UNEPSA; Head of the Research Institute of Pediatrics and Child Health of the National Medical Research Center No. 2 of the Petrovsky National Research Centre of Surgery, Head of the Department of Faculty Pediatrics, Faculty of Pediatrics, Institute of Motherhood and Childhood of the Pirogov Russian National Research Medical University of the Ministry of Health of Russia, Chief freelance pediatric specialist in preventive medicine of the Ministry of Health of Russia

Alekseeva A.A., PhD, Deputy Head of the Consultative and Diagnostic Center for Children - Pediatrician, Head of the Multidisciplinary Pediatric Day Care Hospital - Allergist-Immunologist, Leading Researcher of the Department of Clinical Immunology and Allergology, Research Institute of Pediatrics and Child Health, National Medical Research Center No. 2 of the Petrovsky National Research Centre of Surgery, Member of the Union of Pediatrists of Russia

Andreeva I.V., Senior Researcher, Associate Professor, Institute of Antimicrobial Chemotherapy of the Smolensk State Medical University of the Ministry of Health of Russia, Member of ISCMR

Stetsyuk O.U., Senior Researcher, Institute of Antimicrobial Chemotherapy of the Smolensk State Medical University of the Ministry of Health of Russia, Member of ISCMR

Vishneva E.A., MD, Professor of the RAS, Deputy Head for Scientific Work at the Research Institute of Pediatrics and Child Health, National Medical Research Center No. 2 of the Petrovsky National Research Centre of Surgery, Professor at the Department of Faculty Pediatrics, Faculty of Pediatrics, Institute of Motherhood and Childhood of the Pirogov Russian National Research Medical University of the Ministry of Health of Russia, Member of the Union of Pediatrists of Russia

Gankovsky V.A. – PhD, Otorhinolaryngologist at the Day Care Hospital of Otorhinolaryngology and Audiology, Researcher at the Research Institute of Pediatrics and Child Health, National Medical Research Center No. 2 of the Petrovsky National Research Centre of Surgery, Leading Researcher, Member of the Union of Pediatrists of Russia

Gubanova S.G. – PhD, Otorhinolaryngologist at the Day Care Hospital of Otorhinolaryngology and Audiology, Senior Researcher at the Research Institute of Pediatrics and Child Health, National Medical Research Center No. 2 of the Petrovsky National Research Centre of Surgery, Leading Researcher, Member of the Union of Pediatrists of Russia

Zelenkova I.V. – Head of the Day Care Hospital of Otorhinolaryngology and Audiology, Senior Researcher at the Research Institute of Pediatrics and Child Health, National Medical Research Center No. 2 of the Petrovsky National Research Centre of Surgery, Member of the Union of Pediatrists of Russia

Ivoylov A.Yu., Doctor of Medical Sciences, Professor, Head of the Otorhinolaryngology Department at the Speransky Children's City Clinical Hospital No. 9 of the Moscow Healthcare Department, Head of the Research Department of Pediatric Otorhinolaryngological Diseases at the Sverdzewski Scientific Research Clinical Institute of Otorhinolaryngology of the Moscow Healthcare Department, Professor at the Department of Otorhinolaryngology, Pediatric Faculty, Pirogov Russian National Research Medical University of the Ministry of Health of Russia.

Machulin A.I., Candidate of Medical Sciences, Leading Researcher at the Research Department of Pediatric Otorhinolaryngological Diseases, Sverdzewski Scientific Research Clinical Institute of Otorhinolaryngology of the Moscow Healthcare Department. Otorhinolaryngologist at the Otorhinolaryngology Department, Speransky Children's City Clinical Hospital No. 9 of the Moscow Healthcare Department.

Platonova M.M. – PhD, Researcher at the Research Institute of Pediatrics and Child Health, National Medical Research Center No. 2 of the Petrovsky National Research Centre of Surgery, Pulmonologist

Efendieva K.E. – PhD, Deputy Head for International Relations and Educational Activities, Leading Researcher, Allergist-Immunologist at the Research Institute of Pediatrics and Child Health, National Medical Research Center No. 2 of the Petrovsky National Research Centre of Surgery, Associate Professor at the Department of Faculty Pediatrics, Faculty of Pediatrics, Institute of Motherhood and Childhood, Pirogov Russian National Research Medical University of the Ministry of Health of Russia, Member of the Union of Pediatrists of Russia.

The authors declare no financial support or conflicts of interest that need to be disclosed.

Appendix A2. Methodology for Developing Clinical Guidelines

Target audience for these clinical guidelines:

• Otolaryngologists

• Pediatricians

• General practitioners (family physicians)

• Otorhinolaryngologists-Audiologists

• Dermatovenerologists

• Allergists-immunologists

• Pediatric oncologists

• Pediatric oncologists-hematologists.

• Medical students

• Residents, postgraduate students

Methods used for evidence collection/selection:

electronic database searching.

Description of methods used for evidence collection/selection:

the evidence base for the recommendations includes publications included in the Cochrane Library, EMBASE, and MEDLINE databases. The search depth was

10 years.

Methods used to assess the quality and strength of evidence:

• Expert consensus;

• Assessment of significance in accordance with the rating scale.

Table 1.Scale for assessing levels of evidence (LE) for diagnostic methods (diagnostic interventions)

Table 2. Scale for assessing levels of evidence (LE) for methods of prevention, treatment, and medical rehabilitation, including those based on natural therapeutic factors (preventive, therapeutic, and rehabilitation interventions)

Table 3. Scale for evaluating the levels of recommendation certainty (LRC) for prevention, diagnostic, treatment, and medical rehabilitation methods, including those based on natural healing factors (preventive, diagnostic, therapeutic, and rehabilitation interventions)

Economic analysis:

Cost analysis was not performed, and pharmacoeconomic publications were not analyzed.

Method of recommendation validation:

• External peer review;

• Internal expert review.

Description of the guideline validation method:

The preliminary version of these guidelines was reviewed by independent experts, who were asked to comment primarily on how accessible the interpretation of the evidence underlying the recommendations is for understanding.

Feedback was obtained from primary care physicians and district therapists regarding the clarity of the recommendations and their assessment of the recommendations as a practical tool for daily practice.

The preliminary version was also sent to a non-medical reviewer for comments from the patients' perspective.

Comments received from experts were carefully systematized and discussed by the chair and members of the working group. Each point was discussed, and the resulting changes made to the recommendations were logged. If no changes were made, the reasons for refusing to make changes were logged.

Consultation and peer review:

The draft guidelines were reviewed by independent experts, who were asked to comment primarily on the clarity and accuracy of the interpretation of the evidence base underlying the recommendations.

Working Group:

For the final revision and quality control, the recommendations were re-evaluated by the members of the working group, who concluded that all comments and feedback from the experts had been taken into account and the risk of bias in the development of the recommendations was minimized.

Procedure for updating clinical guidelines.

The mechanism for updating clinical guidelines provides for their systematic revision at least once every three years, as well as upon the emergence of new evidence-based medicine data on the diagnosis, treatment, prevention, and rehabilitation of specific diseases, 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

1. Order of the Ministry of Health and Social Development of the Russian Federation No. 366n dated April 16, 2012, "On Approval of the Procedure for Providing Pediatric Care";

2. 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 Profile 'Otorhinolaryngology'"

3. State Register of Medicinal Products: https://grls.rosminzdrav.ru

4. Federal Law No. 323-FZ dated November 21, 2011, "On the Basics of Protecting the Health of Citizens in the Russian Federation" (Collected Legislation of the Russian Federation, 2011, No. 48, Art. 6724);

5. International Statistical Classification of Diseases and Related Health Problems (ICD-10);

6. Order of the Ministry of Health of Russia No. 205n dated May 2, 2023 (as amended on December 4, 2023) "On Approval of the Nomenclature of Positions of Medical and Pharmaceutical Workers"

7. Order of the Ministry of Health of the Russian Federation No. 541n dated July 23, 2010. "Unified Qualification Handbook of Positions of Managers, Specialists, and Employees, Section: Qualification Characteristics of Positions of Healthcare Workers."

8. Federal Law No. 489-FZ dated December 25, 2018, "On Amendments to Article 40 of the Federal Law 'On Compulsory Medical Insurance in the Russian Federation' and the Federal Law 'On the Basics of Protecting the Health of Citizens in the Russian Federation' regarding Clinical Guidelines."

9. Order of the Russian Ministry of Health No. 103n dated February 28, 2019, "On approval of the procedure and timelines for the development of clinical guidelines, their revision, the standard template of clinical guidelines, and requirements for their structure, composition, and scientific validity of the information included in the clinical guidelines."

10. Order of the Russian Ministry of Health No. 804n dated October 13, 2017, "On approval of the nomenclature of medical services."

11. Order of the Ministry of Labor and Social Protection of the Russian Federation No. 585n dated August 27, 2019, "On Classifications and Criteria Used in Medical and Social Expertise of Citizens by Federal State Institutions of Medical and Social Expertise";

12. Order of the Russian Ministry of Health No. 1094n of November 24, 2021, "On Approval of the Procedure for Prescribing Medicinal Products, Prescription Form Templates for Medicinal Products, the Procedure for Issuing These Forms, Their Accounting and Storage, Prescription Form Templates Containing Prescriptions for Narcotic Drugs or Psychotropic Substances, the Procedure for Their Manufacture, Distribution, Registration, Accounting, and Storage, as Well as the Rules for Issuing Prescription Forms, Including in the Form of Electronic Documents"

Appendix B. Physician Action Algorithms

Appendix C. Patient Information

External otitis (EO) is inflammation of the auricle, external auditory canal, and the outer layer of the tympanic membrane.

Based on external signs, it is difficult to accurately determine whether the disease is caused by a virus or bacteria, as the clinical presentation can be similar. To confirm the etiology of the diagnosis, a special microbiological examination must be performed.

If your child is prescribed an antibiotic, it is very important to complete the full course of treatment.

Prevention of external otitis consists in limiting the use of cotton cotton swabs (thereby preventing trauma to the external auditory canal and excessive removal of protective earwax from the canal); periodic treatment of reusable earplugs, hearing aid ear molds, and headphones with antiseptic solutions.

Treatment is usually outpatient; malignant external otitis requires inpatient treatment. For external otitis caused by bacteria with pronounced general symptoms of the disease (fever, sharp ear pain), antibiotics are prescribed depending on the pathogen and its susceptibility. The necessity of prescription, choice of drug, and duration of the course are determined by the physician.

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

None.