• September 11, 2007, Rocephin (ceftriaxone sodium): Roche informed healthcare professionals about revisions made to the prescribing information for Rocephin to clarify the potential risk associated with concomitant use of Rocephin with calcium or calcium-containing solutions or products.

1. It is recommended that the components to assess for AOM in the history and physical include history of acute onset of symptoms, presence of middle ear effusion (MEE), and signs and symptoms of middle ear inflammation (American Academy of Pediatrics [AAP] Subcommittee, 2004 [S]). See table below entitled "Requirements for Diagnosis of AOM."

   Note 1: Accurate diagnosis of AOM, critical to the management decision, is a competency that may be improved with specific training (Rosenfeld, 2002 [O]; Steinbach & Sectish, 2002 [O]; Pichichero & Poole, 2001 [O]). See CD-rom available in Pratt Library (Wald & Hoberman, 2002 [E]) and an interactive case module on-line with the AAP (http://www.aap.org/otitismedia/www/).

   Note 2: A bulging, cloudy, immobile and distinctly red tympanic membrane (TM) is most helpful in the diagnosis of AOM (Rothman, Owens, & Simel, 2003 [M]; Leibovitz et al., "Can acute otitis media," 2003 [C]; Karma et al., 1989 [D]). See table below entitled "Likelihood Ratios (LR) for Clinical Signs."

   Note 3: A parental report of AOM symptoms is somewhat reliable (sensitivity 71%, specificity 80%, positive predictive value 51%, likelihood ratio [LR] 3.55) (Kontiokari et al., 1998 [C]).

   Note 4: Nonspecific symptoms include cough, rhinitis, poor appetite and vomiting and have likelihood ratios (LR) near 1.0 (Heikkinen & Ruuskanen, 1995 [C], Niemela et al., 1994 [C]).

Table: Requirements for Diagnosis of AOM

(AAP Subcommittee, 2004 [S])

Table: Likelihood Ratios (LR) for Clinical Signs*

(Rothman, Owens, & Simel, 2003 [M]; Karma et al., 1989 [D])

*Likelihood ratios quantify the change in probability of AOM when a given sign or symptom is present in a specific clinical case and depend upon a starting estimate of probability. For more information, see Appendix 2 of the original guideline document for definition and use of likelihood ratios.

**95% Confidence Interval expresses the uncertainty (precision) of a measured value; it is the range of values within which we can be 95% sure that the true value lies. A study with a larger sample will generate more precise measurements, resulting in a narrower confidence interval.

2. It is recommended that pneumatic otoscopy and/or tympanometry be used to enhance accuracy when diagnosing AOM (Spiro et al., 2004 [A]; Karma et al., 1989 [D]; Brookhouser, 1998 [S]; Pelton, 1998 [S]; Jones & Kaleida, 2003 [O]; Pichichero, 2002 [O]; Pichichero & Poole, 2001 [O]).

   Note 1: Pneumatic otoscopy and tympanometry measure the degree of mobility of the tympanic membrane as an indication of the presence of MEE (Jerger, 1970 [C]; Jones & Kaleida, 2003 [O]; Pichichero, 2002 [O]; Pichichero & Poole, 2001 [O]). A large, randomized controlled trial demonstrated that the appropriate use of tympanometry would reduce otitis media diagnoses by 14 to 40% (Spiro et al., 2004 [A]).

   Note 2: Acoustic reflectometry is not often used nor readily available in the Cincinnati area, though the procedure is acceptable for determining the presence of MEE (Block et al., 1999 [C]; Barnett et al., 1998 [C]; Block et al., 1998 [C]; Kimball, 1998 [S]).

3. It is recommended that ear pain (otalgia) be assessed, as determined by discomfort affecting normal activity and/or sleep (Kontiokari et al., 1998 [C]; "The assessment and management," 2001 [S]).
4. It is recommended that, for patients with recurrent AOM, additional attention be paid to parental concerns about hearing loss, speech delay, or language delay (Roberts, Rosenfeld, & Zeisel, 2004 [M]).

Management

General

AOM is a disease with a high spontaneous resolution rate (78 to 80% resolve within 7 to 14 days), and routine antibiotic therapy of all children with suspected AOM results in the treatment of many children in whom there may be either modest benefit and/or modest adverse outcomes from antibiotic therapy (Glasziou et al., 2003 [M]; Marcy et al., 2001 [M]; Rosenfeld et al., 1994 [M]; Dowell et al., "Otitis media," 1998 [S]). Moreover, the decision to use antibiotics and the specific choice of antibiotics must take into account the increasing emergence of bacterial resistance (Doern et al, 1998 [C]; Jacobs et al, 2003 [O]; Mason et al., 2003 [O].

Note: AOM may have potentially serious complications including mastoiditis, meningitis, and intracranial abscess formation. There is an increased incidence of mastoiditis in some countries which limit use of antibiotics for AOM, but a causal relationship is not fully supported by these data. Prevalence of mastoiditis in the U.S. is 0.4%, and 2,500 cases of AOM would need to be treated with antibiotics to prevent one case of mastoiditis (number needed to treat [NNT] = 2,500) (Van Zuijlen et al., 2001 [O]).

Treatment

1. It is recommended that all children with AOM who have a positive assessment for pain be treated with an appropriate analgesic (AAP Subcommittee, 2004 [S]; "The assessment and management," 2001 [S]).

   Note 1: Ear pain in AOM is self-limiting and time is the greatest factor in pain reduction (Sarrell, Cohen, & Kahan, 2003 [A]). Therefore, the immediate availability of a safe and effective analgesic is more important than which agent is used. These include oral agents (acetaminophen or ibuprofen) or topical ear drops (anesthetic or Naturopathic Herbal Extract Ear Drops) (Perrott et al., 2004 [M]; Sarrell, Cohen, & Kahan, 2003 [A]; Sarrell, Mandelberg, & Cohen, 2001 [A]; Bertin et al., 1996 [A]; Hoberman et al., "Efficacy of Auralgan," 1997 [B]; "The assessment and management," 2001 [S]).

   Note 2: In patients with a perforated eardrum and/or discharge from the ear, avoid topical analgesic ear drops as their use will likely result in severe dizziness and vomiting.

2. It is recommended that treatment with a 10-day course of antibiotics be given to children less than 2 years of age with AOM (Cohen et al., 2000 [A], 1998 [A]; AAP Subcommittee, 2004 [S]).

   Amoxicillin, in the dose range of 80 to 90 mg/kg/day is effective in the treatment of a first episode of AOM or for a recurrence more than 1 month since recovery from a prior episode of AOM (Rosenfeld et al., 1994 [M]; Piglansky et al., 2003 [C]; AAP Subcommittee, 2004 [S]). See table below entitled "First-Line Antibiotic Medication and Doses" for doses for this first-line therapy. In cases when the clinician has a high suspicion for concurrent conjunctivitis-otitis media syndrome, commonly caused by a beta-lactamase producing organism, it is reasonable to consider a second-line antibiotic (Wald, 1997 [S]).

   For children with allergies to penicillin, or other reasons to consider alternative antibiotics, consider a second-line antibiotic. In a child less than 1 year of age with a history of a penicillin allergy, a careful review of the reported reaction is prudent. See extended list of antibiotic options, doses, and preparations in Appendix 3 (Rosenfeld et al., 1994 [M]).

   Note: While it is suggested in general that children under two years of age with AOM be treated with antibiotics, it is recognized that in certain situations observation without antibiotics or with a safety-net antibiotic prescription (SNAP) may be reasonable. See table below entitled "Safety-Net Antibiotic Prescription (SNAP) Definition and Management" for SNAP definition. Local data suggest that the relapse/recurrent rate (defined in the study as a new case of AOM occurring between 7 and 60 days from initial episode) is about 3 times higher in children less than 2 years of age (34% compared to 10%) (Siegel et al., 2004 [C]). If observation or SNAP is utilized, both the clinician and the parents are advised to be aware of the higher relapse/recurrence rate in this age group, and close follow-up must be assured (Siegel et al., 2003 [C]).

Table: First-Line Antibiotic Medication and Doses

Table: Safety-Net Antibiotic Prescription (SNAP) Definition and Management

(Siegel et al., 2003 [C])

3. It is recommended that in children over age 2 years with AOM and who are well-appearing, that the treatment options be discussed with the family and that the family be involved in the decision making. The options include:
   • Treatment with a SNAP to be filled after 48 to 72 hours if symptoms do not resolve with observation. See table above for SNAP definition and management.
   • Treatment with a 5-day course of antibiotics (see treatment recommendation 2 and table above entitled "First-Line Antibiotic Medication and Doses" for discussion of antibiotic selection and doses)

     Note 1: There is inadequate evidence to say that antibiotic therapy is or is not beneficial to most children with AOM (Wald, 2003 [E]).

     Note 2: No antibiotic prescription, with follow-up within 48 to 72 hours, is also an option in the specific case when a practitioner would like to control the observation option more closely.

     Note 3: An observation option information sheet for parents is available for use through the Cincinnati Children's Hospital Medical Center (CCHMC) Health Topics Web site (New York Regional Otitis Project, 2002 [X]; Rosenfeld, 2001 [X]).

     Note 4: Parental involvement in the decision to use antibiotic therapy and the use of SNAP with pain control are effective in reducing the use of antibiotics (Pshetizky, Naimer, & Shvartzman, 2003 [B]; Siegel et al., 2003 [C]).

     Note 5: In a Cincinnati office-based study, the relapse/recurrence rate for all ages (new case of AOM occurring between 7 to 60 days from initial episode) was 24% in those that filled the SNAP, compared to 11% in those that did not fill the SNAP, p <0.025 (Siegel et al., 2004 [C]).

4. It is recommended that children over age 2 years with AOM and with severe illness (see table below entitled "Factors to Consider for AOM Treatment") be treated with a 5-day course of antibiotics (see treatment recommendation 2 and table above entitled "First Line Antibiotic Medication and Doses") (Kozyrskyj et al., 2000 [M], 1998 [M]).
5. It is recommended, for a child with a recurrence of AOM in less than 1 month from completion of antibiotic therapy from a prior episode of AOM, or for a child who has recently been on antibiotics for other reasons, that antibiotic choices other than amoxicillin be considered (Leibovitz et al., "Recurrent acute otitis media," 2003 [C]; Carlin et al., 1987 [C]; Dowell et al., "Principles of judicious use," 1998 [S]; Klein, 1998 [S]). For extended list of antibiotic options, doses, and preparations, see Appendix 3 of the original guideline document entitled "Expanded Table of Antibiotic Options, Doses and Preparations."

   Note: There is no strong evidence to support prolonged or prophylactic antibiotic therapy in recurring AOM (Williams et al., 1993 [M]; Koivunen et al., 2004 [A]). Persistent MEE is common, and parents may be counseled to expect fluid to take several weeks to months to clear (Rosenfeld & Kay, 2003 [M]; AAP Subcommittee, 2004 [S]).

6. It is not recommended that other therapies be used in the treatment of AOM (AAP Subcommittee, 2004 [S]).

   Note 1: Steroids, antihistamines, decongestants, and complementary or alternative treatments have not been documented to be efficacious in the treatment of AOM (Butler & Van Der Voort, 2002 [M]; Flynn, Griffin, & Tudiver, 2002 [M]; Barnett et al., 2000 [C]; AAP Subcommittee, 2004 [S]). Antihistamines may prolong the duration of MEE.

   Note 2: Median duration of MEE was 73 days for patients on antihistamine compared to 25 days for patients on placebo (p = 0.04) in a randomized controlled study (Chonmaitree et al., 2003 [A]).

   Note 3: It is recognized that use of complementary and alternative medicine (CAM) is common and its use is often not reported to the primary care physician (PCP) (Eisenberg et al., 1998 [O]; Spigelblatt, 1994 [O]). The primary care physician may take the AOM visit as an opportunity to begin a respectful discussion regarding the safety and efficacy of complementary and alternative medicine with families who report its use.

Table: Factors to Consider for AOM Treatment

Follow-up: to Treatment and Observation Options

7. It is recommended, for the first or a sporadic episode of AOM, that when the initial management approach fails, the clinician reevaluate the antibiotic decision.

   If symptoms worsen at any time or if symptoms do not improve during a waiting period of 48 to 72 hours of initial presentation with AOM, and reexamination continues to suggest that AOM is the appropriate diagnosis, then start amoxicillin if not already initiated or change to an alternative antibiotic if the child is already on a first line drug.

   Note: Options for alternative antibiotics include:

   • Amoxicillin/clavulanate: efficacy has been shown for AOM and may be used when resistance is likely (Hoberman et al., Equivalent efficacy, 1997 [A]; Dagan et al., 2001 [C])
   • Ceftriaxone intramuscularly (IM): 3 consecutive daily doses is efficacious in nonresponsive AOM for children with vomiting or otherwise unable to tolerate oral dosing (Leibovitz et al., 2000 [A]).

   For children with allergies to penicillin, or other reasons to consider another antibiotic choice, see extended list of antibiotic options, doses, and preparations in Appendix 3 of the original guideline document.

8. It is recommended that the clinician reevaluate the patient in 4 to 8 weeks after diagnosis, depending on existing risk factors, to document resolution or persistence of effusion (AAP Subcommittee, 2004 [S]; Local Expert Consensus [E]).

Consults and Referrals

1. It is recommended that a practitioner have a low threshold for referral for an audiologic evaluation by a pediatric audiologist if concerns around hearing, speech, or language are raised by parents, clinician, or other caregivers because of recurrent AOM (Mandel et al., 1991 [A]; Hsu, Levine, & Giebink, 1998 [C]; Teele et al., 1990 [C]; Bachmann & Arvedson 1998 [S]).
2. It is recommended that a child be referred for an otolaryngological evaluation for:
   • Recurrent AOM (history of 6 episodes over a 12-month period taking into account the severity of episodes, clustering of episodes, and persistence of otitis media with effusion)
   • Persistent otorrhea
   • Concerns about mastoiditis, or other complications of AOM
   • Perceived need for tympanocentesis and/or myringotomy (e.g., acute episode not responsive to medical therapy)
   • Abnormal audiologic evaluation

   (Froom et al., 1993 [C])

Education

1. It is recommended that the family be educated regarding the natural history of AOM, signs and symptoms of clinical deterioration, and appropriate follow-up.
2. It is recommended that the practitioner discuss with the parent that persistent MEE is common, and parents may expect fluid to take several weeks to months to clear (Rosenfeld & Kay, 2003 [M]; AAP Subcommittee, 2004 [S]).
3. It is recommended that the family be educated about preventable risk factors. These include:
   • Exposure to others (especially family members) with upper respiratory tract infections (Uhari, Mantysaari, & Niemela, 1996 [M])
   • Parental smoking or other sources of second-hand smoke (Uhari, Mantysaari, & Niemela, 1996 [M]; Ilicali et al., 1999 [C])
   • Daycare attendance (Uhari, Mantysaari, & Niemela, 1996 [M]; Bradley, 2003 [C])

     Note: Though daycare attendance may not be preventable, options to reduce risk of AOM include delaying daycare, selecting a setting with fewer children, and/or verifying the daycare facility's hand washing practices and availability of sinks.

   • Excessive pacifier use, limiting use to when the child is falling asleep (Uhari, Mantysaari, & Niemela, 1996 [M]; Niemela et al., 2000 [A])
   • Breastfeeding duration less than 3 months (Uhari, Mantysaari, & Niemela, 1996 [M])
   • Bottlefeeding with the child on his/her back: assure that infants are offered bottle feedings while sitting in upright positions (Tully, Bar-Haim, & Bradley, 1995 [B]

   Parents may also benefit by understanding nonpreventable risk factors or common misconceptions.

   • Anatomy of the eustachian tube in young children
   • It is not always known why a child gets AOM.
   • Allergies do not cause AOM.

Definitions:

Evidence Based Grading Scale:

A: Randomized controlled trial: large sample
B: Randomized controlled trial: small sample
C: Prospective trial or large case series
D: Retrospective analysis
E: Expert opinion or consensus
F: Basic laboratory research
S: Review article
M: Meta-analysis
Q: Decision analysis
L: Legal requirement
O: Other evidence
X: No evidence

References open in a new window

For information about availability, see the "Availability of Companion Documents" and "Patient Resources" fields below.

Electronic copies: Available from the Cincinnati Children's Hospital Medical Center Web Site.

For information regarding the full-text guideline, print copies, or evidence-based practice support services contact the Children's Hospital Medical Center Health Policy and Clinical Effectiveness Department at HPCEInfo@chmcc.org.

Electronic copies: Available in Portable Document Format (PDF) from the Cincinnati Children's Hospital Medical Center Web site.

• Appendix 1: resources for patient/family education purpose. Cincinnati Children's Hospital Medical Center, 2004. Electronic copies available from the Cincinnati Children's Hospital Medical Center Web site.
• Ear infections and acute otitis media. Cincinnati Children's Hospital Medical Center, 2004. Electronic copies available from the Cincinnati Children's Hospital Medical Center Web site.
• Types of hearing tests. Cincinnati Children's Hospital Medical Center, 2004. Electronic copies available from the Cincinnati Children's Hospital Medical Center Web site.
• Managing ear infections (acute otitis media). Cincinnati Children's Hospital Medical Center, 2004. Electronic copies available from the Cincinnati Children's Hospital Medical Center Web site.

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