US Pharm. 2009;34(3):12-15. 

Most pharmacists have been confronted by a parent whose child has an apparent ear infection, usually otitis media. The parent understandably wants to relieve the child’s pain, but nonprescription products are of no use in ear pain or otitis media, which greatly limits the scope of advice the pharmacist can offer the parent. However, the pharmacist should understand various facts about the condition in order to answer the parent’s questions. 

Prevalence of Pediatric Otitis Media

The annual number of cases of otitis media in all segments of the population is unknown, but is estimated to be approximately 2.2 million (otitis media with effusion) to 5 million (acute otitis media).1,2 Focusing exclusively on pediatric cases, experts estimate that 75% of children will suffer one or more episodes by the age of 3.3-5 Furthermore, approximately one-half of those who do contract an ear infection will experience three or more ear infections by the age of 3 years.4 These startling statistics are further buttressed by the fact that ear infections are the most common illnesses experienced by babies and young children and are the number one cause of consultations with physicians, and that otitis media is the most common cause of hearing loss in children.3,6,7 

Otitis media is responsible for at least $5 billion each year in medical costs and lost wages.4 Acute otitis media requires more than 20 million antibiotic prescriptions yearly, and it has been identified as the most common justification for prescribing antibiotics in children.8-10 Approximately 20% of children develop a form of acute otitis media that is recalcitrant to treatment, being characterized by increased persistency and recurrences.11 

Subtypes of Otitis Media

Otitis media is subdivided into several separate conditions. One is acute otitis media (AOM). The National Institute on Deafness and Other Communication Disorders (NIDCD) explained that AOM denotes a painful infection in which certain ear structures are infected and inflamed, with fluid and mucus being trapped in the ear.3 

By contrast, the NIDCD defines otitis media with effusion (OME) as a noninfectious condition in which fluid and mucus are trapped in the ear, possibly following a bout of AOM, a condition also referred to as “glue ear” or serous otitis media.2 This condition makes it more difficult to resist future infections and can also affect hearing. 

The National Institutes of Health defines chronic otitis media as a subcategory of otitis media in which fluid persists, and there may or may not be infection with bacteria or viruses.12 The agency also defines suppurative chronic otitis as a situation in which the eardrum undergoes repeated bouts of rupture or draining or in which middle ear or mastoid inflammation persists. 

The medical literature utilizes a third term for a subtype of otitis media, recalcitrant or difficult-to-treat otitis media.1,11 The patient begins with a case of acute otitis media, but antibiotic therapy fails to effect an improvement in signs and symptoms after 48 to 72 hours or more. In addition, the patient with this condition has had three or more episodes in the past six months, or has experienced four or more episodes in the year prior to the present incident. 

Epidemiology of Pediatric Otitis Media

Children are the most common targets for otitis media, as the peak incidence is four to 24 months.1 This is due to a combination of genetic, infectious, immunologic, and environmental characteristic and factors peculiar to pediatric patients.1 For instance, the shape and caliber of the eustachian tube in children favor infection, as does the fact that children’s immunologic systems are immature and still developing.4 

Breast-fed children have a decreased incidence of otitis media as opposed to those who feed from a bottle while lying down.1,4 This may be due to a specific position assumed during breast-feeding, to the movements required in suckling, or to breast milk’s well-known ability to protect from infection.1 Use of pacifiers increases the incidence of otitis media. 

Attending day care is associated with an increased incidence of the condition. Being around air pollution or smokers is also a risk factor, much more so if the smokers are the parents themselves.1,3 The risk is greater in babies of Native American, Alaskan, or Canadian Inuit background. Otitis media is more common in children of lower socioeconomic status, perhaps secondary to such contributing factors as crowded conditions, inappropriate hygiene, improper nutrition, and limited access to medical care.8 

Etiology of Pediatric Otitis Media

Otitis media occurs as the culmination of a sequence of events. The inciting factor in most cases is another condition that also causes congestion and inflammation of the nasal mucosa, nasopharynx, and eustachian tube.1 Thus, otitis media may follow such causative conditions as allergic rhinitis or an upper respiratory tract infection. 

When the patient has an infection, bacteria are able to move through the lining or passageway of the eustachian tube to reach the middle ear.4 Infection causes inflammation of the middle ear lining, obstructing the eustachian tube at its narrowest segment (also known as the isthmus).1,4 White blood cells and bacterial residue collect to form thick, yellowish pus in the middle ear. Middle ear secretions and air cannot exit as they normally do, and they collect (effusion). 

Eustachian tubes in children are smaller and straighter than those in adults.3 This anatomic distinction lessens the ability of water to drain from the ear, predisposing children to otitis media. 

Adenoids, located in the throat in close proximity to the eustachian tubes, are also prone to infection and inflammation, which can block eustachian tube openings and cause the same problems as when the common cold is the cause.3 Adenoids in children are larger than those in adults, predisposing them to adenoid-induced eustachian blockage. 

Microbiology of Pediatric Otitis Media

When effusion fluids from pediatric patients with acute otitis media are examined, the usual organisms isolated are Streptococcus pneumoniae (40%-50% of cases), Haemophilus influenzae (30%-40% of cases), and Moraxella catarrhalis (10%-15% of cases).1 When a child has experienced persistent or recurrent acute otitis media, the most common offender is penicillin-resistant strains of S. pneumoniae

Manifestations of Pediatric Otitis Media

Physicians establish a diagnosis of acute otitis media using three diagnostic criteria: 1) acute, rapid onset of symptoms; 2) middle ear effusion as noted by bulging of the tympanic membrane; and 3) signs and symptoms consistent with inflammation of the middle ear.13 Infants and young children may display such nonspecific manifestations as diarrhea, vomiting, anorexia, fever, headache, irritability, cough, rhinitis, listlessness, and pulling or tugging at the ears.1 Overt ear pain is less common in children under the age of 2 years, but more common in adolescents and adults. 

Complications of Pediatric Otitis Media

If the problem persists for a sufficient period, the child’s hearing is seriously compromised due to an inability of the tympanic membrane and middle ear bones to vibrate normally.4 Eventually, the child’s speech and language are affected.3 This occurs because the child must hear normally to allow him or her to interpret normal speech and imitate it as language and speaking skills evolve. Severe ear pain is common, and rupture of the tympanic membrane is a possibility.4 Infection can extend to areas such as the mastoid or brain.4,12

Treatment of Pediatric Otitis Media

The goals of treating pediatric otitis media are to resolve symptoms and reduce the risk of its recurrence.1 Antibiotics are the most often recommended medication in active otitis media, with analgesics for ear pain.4 Unfortunately, about 34% of streptococcal infections are now resistant to penicillin, and 22% are resistant to multiple medications.9 

A set of guidelines from the National Guideline Clearinghouse states that amoxicillin should be the first choice for all cases of acute otitis media.14 The recommended dose is 80 mg/kg/day in two equally spaced, divided doses for five to 10 days in those aged less than 4 years, and 40 to 60 mg/kg/day for those aged 4 years and above. If the patient is allergic to amoxicillin, the guideline suggests a single dose of azithromycin dosed at 30 mg/kg. If the infection fails to respond to amoxicillin after 72 hours, the guideline recommends administration of amoxicillin/clavulanate dosed at 80 mg/kg/day of amoxicillin component, divided into two equally spaced daily doses for 10 days, or azithromycin 20 mg/kg daily for three days. 

If the child has OME, antibiotics are not indicated, as there is no infectious component. However, the child must have periodic examinations to ensure that the effusion has cleared, and possible appointments with otolaryngologists to assess the impact of hearing loss on language delay.14 If fluid persists for more than three months and the child has hearing loss, physicians may place tubes in the eardrum in the procedure known as a myringotomy

Precautions in Pharmacist Recommendations

The patient with any type of ear pain or suspected otitis media must be referred to a physician or pediatrician for assessment. It is improper for the pharmacist to recommend any nonprescription product, such as decongestants (e.g., pseudo ephedrine), antihistamines, or analgesics and suggest that the patient will thereby be able to avoid an appointment with a physician. 

Pharmacists may field questions about the use of olive oil (sweet oil) in the ear when the child has ear pain or an apparent ear infection.13 The patient may volunteer that the person who recommended this old home remedy also said the olive oil should be warmed prior to instillation. Placing warm oil in the ear may temporarily soothe the ear that is pained with otitis media. However, the pharmacist should explain that the source of the ear pain and infection is beyond the tympanic membrane. Olive oil cannot (and should not) pass through an intact tympanic membrane. Its use delays securing appropriate care for the child, and applying it only gives a false sense of security to parents and caregivers. 


Otitis media is a common type of ear infection caused by viruses or bacteria that infect the ear, usually after the child has a cold or other illness. 

What Are the Signs of an Ear Infection?

Some children with ear infections are too young to tell their parents what is wrong. What are the signs of ear infection in children? The child may have trouble sleeping or cry more than usual, similar to the child with colic. However, with an ear infection, the child also has signs that point to ear involvement, such as loss of balance, trouble hearing (e.g., not responding to quiet sounds or whispered words), or fluid draining out of the ears. The child may also tug or pull at his or her ears. 

What Are the Consequences?

Ear infections that continue for a sufficient period can have devastating consequences for the child’s health. Your child’s hearing occurs as a result of several complicated processes. The outer ear collects the sounds, funneling them to the eardrum. Beyond the eardrum is the middle ear, which is filled with air and contains three tiny bones that conduct the sounds from the eardrum to the inner ear. In the inner ear, sound vibrations are converted to electrical impulses that the brain can register as sounds. 

For sounds to be properly heard by your child, the middle ear and inner ear must be healthy. If the middle ear fills so that fluid and mucus are trapped inside it, your child could develop hearing problems. If otitis media continues for a long period (chronic otitis media), the child may have problems speaking and developing language skills due to the impaired hearing. 

How to Care for an Ear Infection

To make sure that your child does not develop serious problems, you must get your child immediately to a physician or an emergency room, for an examination by a physician or other licensed caregiver. If the cause is thought to be due to bacteria, antibiotics will be prescribed. The entire course of antibiotics must be taken, just as directed. Sometimes the child stops complaining of the pain after just a few days, and seems better. Despite this, do not stop the antibiotics early, or the infection may not be eradicated and may return. If the ear infection is due to viruses, however, antibiotics are not effective. In this case, simply follow the medical advice you are given by the child’s physician or pediatrician. Caregivers may also suggest safe analgesics, such as acetaminophen or ibuprofen. Be sure to follow the directions given by the physician to prevent overdosing. 

There are no nonprescription products or devices for ear infection or ear pain that will make it unnecessary to take your child to a physician. Products for earwax are useless, as are those for water trapped in the outer ear after swimming or bathing. Decongestants and antihistamines have no proven value and should not be used. 

Remember, if you have questions, Consult Your Pharmacist. 


1. Ramakrishnan K, Sparks RA, Berryhill WE. Diagnosis and treatment of otitis media. Am Fam Physician. 2007;76:1650-1658.
2. Powers JH. Diagnosis and treatment of acute otitis media: evaluating the evidence. Infect Dis Clin North Am. 2007;21:409-426.
3. Ear infections: facts for parents about otitis media. National Institute on Deafness and Other Communication Disorders.
hearing/otitismedia.asp. Accessed January 29, 2009.
4. Otitis media (ear infection). National Institute on Deafness and Other Communication Disorders.
hearing/otitism.asp. Accessed January 29, 2009.
5. Tewfik TL, Mazer B. The links between allergy and otitis media with effusion. Curr Opin Otolaryngol Head Neck Surg. 2006;14:187-190.
6. Del Cuvillo A, Sastre J, Montoro J, et al. Use of antihistamines in pediatrics. J Investig Allergol Clin Immunol. 2007;17(suppl 2):28-40.
7. Rovers MM, Glasziou P, Appelman CL, et al. Antibiotics for acute otitis media: a meta-analysis with individual patient data. Lancet. 2006;368:1429-1435.
8. Bernius M, Perlin D. Pediatric ear, nose, and throat emergencies. Pediatr Clin North Am. 2006;53:195-214.
9. Johnson NC, Holger JS. Pediatric acute otitis media: the case for delayed antibiotic treatment. J Emerg Med. 2007;32:279-284.
10. Meropol SB. Valuing reduced anti biotic use for pediatric acute otitis media. Pediatrics. 2008;121:669-673.
11. Leibovitz E. The challenge of recalcitrant acute otitis media: pathogens, resistance, and treatment strategy. Pediatr Infect Dis J. 2007;26(suppl):S8-S11.
12. Otitis media–chronic. National Institutes of Health. Medline Plus. http://medlineplus.nlm.nih.
gov/medlineplus/ency/article/ 000619.htm. Accessed January 29, 2009.
13. Spiro DM, Arnold DH. The concept and practice of a wait-and-see approach to acute otitis media. Curr Opin Pediatr. 2008;20:72-78.
14. Otitis media. National Guideline Clearinghouse.
summary.aspx?doc_id=11685&nbr= 6032&ss=6&xl=999. Accessed January 29, 2009.
15. Leach AJ, Morris PS. Antibiotics for the prevention of acute and chronic suppurative otitis media in children. Cochrane Database Syst Rev. 2006;(4):CD004401. 

To comment on this article, contact