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There are many adjunctive pharmacotherapy options to consider for acute otitis media
Because most episodes of AOM cause significant pain to the infant or child, assessment and treatment of discomfort is essential.
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This month’s Pharmacology Consult will review non-antibiotic pharmacotherapies for acute otitis media. What are effective treatment options for analgesia for acute otitis media? Do antihistamines or decongestants have a role in the therapy of acute otitis media? These issues are discussed below.
Systemic analgesics therapies
As most episodes of AOM cause significant pain to the infant or child, assessment and treatment of discomfort is essential. The Clinical Practice Guideline, Diagnosis and Management of Acute Otitis Media, published in 2004 by the AAP and the AAFP, specifically addresses AOM pain.
Recommendation two of the guideline states that an assessment should be made for pain due to AOM, and if present, it should be treated. Although several treatment options are available to clinicians, none have been well studied. This is unfortunate considering the high prevalence of AOM.
Pharmacologic treatment options listed in the guideline include acetaminophen, ibuprofen, topical analgesics and opioids (eg, codeine). Acetaminophen and ibuprofen are effective analgesic agents, and they are commonly used for treatment of pain in infants and children due to AOM and other conditions.
A literature review for these agents in AOM treatment finds only one controlled study (Bertin). This study compared acetaminophen in a low dose (10 mg/kg three times daily) to ibuprofen (10 mg/kg three times daily) to assess for change in the appearance of the tympanic membrane (landmarks, color) and pain relief.
Acetaminophen and ibuprofen did not differ and were equivalent to placebo when tympanic membrane appearance was evaluated. Thus, no apparent beneficial effect was seen from the theoretical advantage of ibuprofen’s pharmacologic antiinflammatory effects over acetaminophen. Ibuprofen was more effective for pain relief than acetaminophen, which did not differ from placebo. The low dose of acetaminophen used in this study limits this conclusion.
Codeine is also listed in the AAP guideline as an analgesic treatment option for AOM. No controlled studies evaluating codeine for this use can be found in the published literature. Overall, relatively few data are available from controlled studies evaluating the efficacy of codeine for pain treatment in children.
Clinicians often perceive codeine as an effective analgesic, as it is an opioid. This deserves clarification and review, however. The codeine molecule has low affinity for endogenous opioid receptors. Codeine is hepatically demethylated to morphine, which provides analgesic effects. However, only 10% of administered codeine is converted to morphine.
Common starting doses of codeine are less than this 10-1 conversion ratio as compared with morphine dosing. Thus, typical codeine doses may not provide sufficient analgesia from hepatically converted morphine. Larger doses may be limited by codeine’s adverse effects, including nausea and vomiting.
It is known that the hepatic drug metabolizing enzyme system (CP450 2D6) responsible for this conversion is subject to significant genetic polymorphism. For example, approximately 10% of white people are unable to convert codeine to morphine.
Analgesic therapies – topical
Topical otic analgesics can also be used to effectively treat pain due to AOM. A combination topical product (antipyrine, benzocaine, glycerin) has been shown in a controlled trial of children aged 5 years and older to effectively reduce pain due to AOM when given with acetaminophen. Antipyrine is an analgesic agent, benzocaine functions as a local anesthetic and glycerin has hygroscopic properties, which decrease fluid pressure.
Products containing these ingredients include Allergen Ear Drops, Antipyrine and Benzocaine Otic and Auroguard Otic. Similarly, a naturopathic ear product (may be found as “ear oil” in natural food stores) was found to be equally effective in children aged 6 years and older as a topical otic analgesic product in a controlled study.
Although the ingredients in available ear oil products may vary, the product evaluated in the above study contained garlic, Mullien flower, St. John’s Wort and Calendula flores. It is important to consider, however, that as naturopathic products are unregulated, the ingredients and amounts listed on product labels can widely vary. Still, some caregivers may prefer these products, as they are natural.
Antihistamines, decongestants
Antihistamine and decongestant agents have no role in the treatment of acute otitis media in an otherwise healthy child, nor do they provide any benefit in the therapy of otitis media with effusion. Antihistamines and decongestants have been evaluated in a controlled fashion for this purpose in several published studies. None of these studies demonstrated a beneficial effect on otitis media with effusion resolution.
Despite the common occurrence of AOM in infants and children, few data are available from controlled trials to document the efficacy of the limited pharmacotherapeutic choices to treat pain from AOM. With the recent national endorsement of observation without immediate antibiotic therapy for AOM, some infants and children may not require a systemic antibiotic to adequately resolve their AOM episodes.
Acetaminophen and ibuprofen can be used, and as it has been discussed on numerous occasions in the Pharmacology Consult column (albeit in different venues), when recommending acetaminophen or ibuprofen, it is imperative that adequate instructions and education be given to caregivers. This includes recommendation for a specific weight-based dose (maximal doses may be necessary for more severe pain), adequate dosage form to use (including differences in available dosage forms), how often to administer the dose, dose measurement and avoidance of toxicity (ie, place acetaminophen bottle out of reach when not used).
As published study results have documented, it may not be enough to tell parents, “Give him some acetaminophen.” Topical analgesics can also be used, as they can provide additional analgesia. The AAP has recommended that clinicians ask caregivers of children with AOM if they are administering complementary and alternative medical treatments (eg, herbal products, homeopathy and nutritional supplements). Although complementary and alternative medical treatments are commonly used, few data are available on their safety and efficacy.
For more information:
- Edward A. Bell, PharmD, BCPS, is a Professor of Pharmacy Practice at Drake University College of Pharmacy and a Clinical Specialist at Blank Children’s Hospital, Des Moines, Iowa.
- AAP Subcommittee on Management of Acute Otitis Media. Clinical practice guideline – diagnosis and management of acute otitis media. Pediatrics. 2004;113:1451-1465.
- Hoberman A, Paradise JL, Reynolds EA, Urkin J. Efficacy of auralgan for treating ear pain in children with acute otitis media. Arch Pediatr Adol Med. 1997;151:675-678.
- Sarrell EM, Mandelburg A, Cohen HA. Efficacy of naturopathic extracts in the management of ear pain associated with acute otitis media. Arch Pediatr Adolesc Med. 2001;155:796-799.
- AAFP, American Academy of Otolaryngology-Head and Neck Surgery, AAP Subcommittee on Otitis Media with Effusion. Otitis media with effusion. Pediatrics. 2004;113:1412-1429.
- Mandel EM, Casselbrant ML. Recent developments in the treatment of otitis media with effusion. Drugs. 2006;66:1565-1576.