Otitis Media Update

1
Otitis Media Update

• Lisa M. Gagnon, MSN, CPNP
• Connecticut Pediatric Otolaryngology

2
Otitis Media The Magnitude of the problem..

• It is the most common reason for a child to be
  brought in for a sick visit, and subsequently the
  most diagnosed disorder (12)
• Cost is astronomical
• Over 3.5 billion/year in the US in direct
  indirect cost
• Proficient Diagnosis of AOM and OME are
  essential to ensure appropriate care, minimize
  complications, and avoid the overuse of
  antibiotics.

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Diagnosis Management of Acute Otitis Media

• Evidence Based Guidelines developed to provide
  recommendations to primary care clinicians for
  the management of children from 2 months-12years
  of age with uncomplicated Acute Otitis Media.
• American Academy of Pediatrics
• American Academy of Family Physicians
• Experts in the Field of Otolaryngology (AAO),
  Infectious Disease, Epidemiology

4
The Recommendations

• Diagnosis of AOM should include history of acute
  onset, SS of Middle Ear Effusion, SS of middle
  ear inflammation.
• Management of AOM should include assessment of
  pain.
• Observation without use of antibacterial agents
  in a child with uncomplicated AOM is an option
  for select children.
• If treating with antibacterial agent, amoxacillin
  should be first line (non-allergic patient).

5
The Recommendations (continued)

• Reassessment of patient if he/she does not
  respond in 48-72hrs.
• Encourage prevention of AOM through reduction of
  risk factors.
• No recommendations for complementary and
  alternative medicine (CAM) for treatment of AOM.

6
The Diagnosis

• 3 Main Criteria
• Acute Onset of Signs Symptoms
• Presence of Middle Ear Effusion (MEE)
• Signs or Symptoms of Middle Ear Inflammation
• (Otalgia clearly referable to the ear,
  Erythema)

7
Research on Diagnosis

• Diagnostic Certainty for Acute Otitis Media
• Rosenfeld, RM Int J Pediatric
  Otorhinolaryngology Jun 2002
• Convenience Sample of Primary Care Physicians
  surveyed after diagnosing AOM in 135 children
• age 0.3 to 11.8years. Mean age 2.4 years
• Clinicians expressed high certainty for AOM
  diagnosis in 122/135 episodes (90).
• Prevalence of true AOM was 70
• (40 false positive diagnoses 35 did not have
  MEE,
• 5 did not have acute signs or symptoms)

8
How we are challenged.

• Clinical History is a poor predictor
• A clear view isnt always easy
• Examining a crying child can be tough!

9
Presence of MEE

• Can be confirmed with pneumatic otoscopy
• Can be supplemented with by tympanometry and/or
  acoustic reflectometry
• (This is a billable service)
• Tympanocentesis/Tympanic Perforation

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Tympanometry

• Probe is placed snugly in external canal. A
  sound stimulus generator transmits acoustic
  energy (tone) into the canal, while a vacuum
  pump introduces positive and negative pressures
  into the ear canal. A microphone in the
  instrument detects returning sound energy.

11
Discriminating against AOM OME

• OME is more common than AOM
• May accompany viral URI
• May be a residual of a resolved AOM
• Minimal discomfort for OME (ETD)

12
Treatment of AOM- Do we need to treat?

• Observation Option
• Deferring antibacterial treatment of
  selected children for 48-72hrs and limiting
  management to symptomatic relief.
• Children 6mo-2yrs with non-severe illness at
  presentation and an uncertain diagnosis
• Children 2yrs of age and older without severe
  symptoms at presentation or with an uncertain
  diagnosis

13
Research supporting observation option.

• Eskrin, B., Should Children with Otitis Media be
  Treated with Antibiotics?
• Annals of Emergency Medicine (44)5. Nov 2004
• Systematic Review Abstract from the Cochrane
  Database of Systematic Review
• (Antibiotics for Acute Otitis Media in Children)
• Glasziou,P.P., Del Mar CB, Sanders,
  SC, Hayem M.)
• Study Selection Randomized Controlled Clinical
  Trials involving Children with otitis media and
  comparing antibiotics versus placebo control
• Ten Studies met criteria
• Data extracted were patient-oriented outcomes.

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Research supporting observation option

• No difference in hearing loss between treatment
  and placebo groups (follow up audiometry)
• Antibiotics did not prevent relapse, perforation
  or development of otitis media in the contra
  lateral ear
• Adverse effects (rash, vomiting, diarrhea) were
  more common in the antibiotic groups
• 62 of patients in the placebo groups had no pain
  after 24hrs, between 2 and 7 days , this
  increased to 78.
• Eskrin, B., Should Children with Otitis Media be
  Treated with Antibiotics?
• Annals of Emergency Medicine (44)5. Nov 2004

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Evidence for Observation (Continued)

• Spontaneous rate of primary control without
  antibiotics or tympanocentesis was 81
• Compared with placebo or no drug, antimicrobial
  therapy increased primary control by 13.7
• (Rosenfeld, R, et al, Clinical Efficacy of
  Antimicrobial Drugs for Acute Otitis Media
  Metaanalysis of 5400 children from thiry-three
  randomized trials. J Pediatrics Mar 1994

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Equivocal Data. Saux Study

• A Randomized, double-blind, placebo-controlled
  non-inferiority trial of Amoxacillin for
  Clinically Diagnosed Otitis Media in Children 6
  months to 5 years of Age (Saux, et.al, CMAJ
  February 2005
• Study was conducted each winter between December
  1999-March 2002
• 512 Children 6mo-lt6yrs, new onset SS, MEE,
  redness or bulging of TM, randomly assigned to
  receive Amoxacillin 60mg/kg/day divided TID or
  Placebo x 10d
• Follow-up via telephone call initially,
  Examination at 1mo 3mo for presence of MEE

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Saux Study, Cont

• Primary outcome measure was clinical resolution
  of symptoms, defined as absence of receipt of an
  antimicrobial (other than Amox) within 14 days
• No statistical differences in adverse effects
  (diarrhea, rash) between the 2 groups
• No significant differences in recurrence rates or
  middle ear effusion at 1 and 3 months.
• At 14 days 84 placebo group and 92.8 of the
  treatment group had clinical resolution of
  symptoms
• Children who received placebo had more pain and
  fever in the first 2 days

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Evidence against Observation Option

• The Metaanalysis Research Design of most of
  the studies is limited by how AOM was defined or
  diagnosed
• The role of antibiotics may not be minimal in
  most cases of AOM. There may have been
  misdiagnosis of MEE indiscriminant use of
  antibiotics for MEE and for viral URIs.

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Evidence against Observation

• Complication rate is increased in countries where
  antibiotic prescribing is low.
• Mastoiditis (1991-1998)
• 3.8/100,000 in Netherlands
• 1.2/100,000 in higher
• prescribing nations
• (Vanauijlen, Schilder, VanBalen, Hoes
• Pediatric Infectious Disease J Feb 2001)
• Delay of Symptomatic Relief
• Legal Concerns

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AAP/AAFP/AAO view on Mastoiditis (from
recommendations)

• Current evidence does not support increased risk.
• The AHRQ evidence report of AOM concluded that
  mastoiditis is not increased with initial
  observation, provided that children are followed
  closely and antibacterial therapy is initiated in
  those who do not improve
• Pooled data from 6 randomized trials 2 cohort
  studies showed comparable rates of mastoiditis in
  Children (0.59) who received antibacterial
  therapy and children (0.17) who received placebo
  or observation (p.212)

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AAP/AAFP/AAO Guidelines for Treatment

• Antibiotic Management of Children with initial or
  uncomplicated episodes of acute otitis media
• _________________________________________
• Tempgt39C, severe Recommended (PCN
  allergy)
• Earache or both
  Non-type I
• Amoxicillin
  Cefdinir
• No (80-90mg/kg)
  Cefuroxime
• 
  Type I
• 
  Azithromycin, Clarithromycin
• 
  Bactrim, EES, Clindamycin
• Yes Amoxacillin/Clavulanate
  Ceftriaxone (3d)
• (90/6.4mg/kg/d)
  (non-type I)

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Treatment of AOM Consider the
Microbiology

• Table 1 Microbiology of acute otitis media in
  children immunized with PCV7 or Control Vaccine
• __________________________________________________
  __
• 
  No. episodes
• Microbiology of AOM PCV7 No.()
  Control No.()
• Pneumococcal (all) 271
  414
• Vaccine Serotype-S.Pneumo 107
  250
• Cross-reactive serotypes 41
  84
• Nonvaccine serotypes 125
  95
• Haemophilus influenzae 315
  287
• Moraxella Catarrhalis 379
  381
• Data from Eskola J, Kilpi T, Palmu A, et al.
  Efficacy of a pneumococcal conjugate vaccine
  against acute otitis media. N Engl J Med
  2001344403-9

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Otitis Media with Effusion

• AAP, AAFP, AAO-HNS Release Guidelines on
  Diagnosis and Management of Otitis Media with
  Effusion
• 1a Use of Pneumatic Otoscopy to diagnose OME.
• 1b Use of Tympanometry to confirm diagnosis of
  
• OME.
• 1c Population based screening for OME is not
• recommended.
• 2 Clinicians should document the laterally and
  
• duration of effusion, and the presence and
  severity
• of symptoms at each assessment of OME

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Otitis Media with Effusion (Recommendations,
cont)

• Distinguish the child with OME who is at risk for
  speech, language, or learning problems and
  evaluate need for hearing/speech/language
  intervention
• Clinicians should manage the child with OME who
  is not at risk with watchful waiting for three
  months from the date of effusion/diagnosis.
• Antihistamines Decongestants are ineffective or
  OME and are not recommended
• Hearing testing is recommended for OME gt 3mo

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Otitis Media with Effusion (Recommendations,
cont)

• Children with persistent OME, who are not at
  risk, should be re-examined at 3-6 month
  intervals
• Referrals from PMD should include information of
  duration of effusion reason for referral
• Tympanostomy Tube insertion is the preferred
  initial procedure for surgical candidates.
• No recommendations on CAM therapy
• No recommendation on Allergy Management

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Otitis Media with Effusion Are there any
treatment options?

• A randomized, Placebo-controlled trial of the
  effect of antihistamine or corticosteroid
  treatment in acute otitis media. Chonmaitree,
  T., et al, J of Pediatrics, September 2003
• 179 children 3mo 3 yrs enrolled in a
  randomized, double-blind, placebo controlled
  trail.
• Each child received IM ceftriaxone, and either
  chlorpheniramine maleate (0.35mg/kg/d) and/or
  prednisolone (2mg/kg/day) for 5 days.
• Outcome measures Rate of treatment failure,
  duration of MEE, Rate of AOM recurrence

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Otitis Media with Effusion

• Children who received antihistamine alone had
  significantly longer duration of MEE.
• Clinical Outcomes and recurrence rates did not
  differ significantly with treatment.
• 5-day treatment with antihistamine or
  corticosteroid, in addition to antibiotic did not
  improve AOM outcomes.
• Antihistamine use during an acute episode of OM
  should be avoided
• Chonmaitree, T., et al, J of Pediatrics,
  September 2003

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Effect of Montelukast Sodium on the Duration of
Effusion of Otitis MediaCombs, J.T., Clinical
Pediatrics 2004

• Randomized, Controlled, double-blind study
• 60 Children age 2-12 years with clinical
  diagnosis of AOM (met criteria)
• All patients received Amoxacillin 40-50mg/kg/day
  for 10 days
• Patient received either Montelukast Sodium or
  Placebo (29/31)

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Montelukast Sodium OM

• Tympanometry or Spectral gradient acoustic
  reflectometry were the objective tools used to
  define effusion (Done _at_ entry at follow-up
  visit 4 weeks later)
• Ears were clear of Effusion in 5 of 31 (16) in
  the placebo group and 17 of 29 (58) in the
  MK/treatment group
• Difference was significant. Plt.003
• Limitations Sample size, Demographic Data
  differences

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Reduction of Risks Associated with OM

• Educating parents/guardians on modifiable risk
  factors
• Smoking
• Breast Feeding
• Vaccines Prevnar, Influenza
• Daycare
• Bottle/Pacifier Use

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The Safety net.

• Study done by the Cincinnati Pediatric Research
  Group (Ohio, Kentucky, Indiana)
• 194 Children 1-12yrs with uncomplicated AOM
  enrolled I 11 offices (175 completed)
• Safety net Rx for antibiotic instructed not to
  fill it unless SS increased or did not resolve
  in 2 days.
• Only 55 (31) of the 175 had filled Rx
• 63 parents would treat future AOM without
  antibiotics and with pain control alone.

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Applying the Evidence

• A two-year old boy presents with one day of
  tugging at his right ear, a runny nose, and a
  temp of 37.9C (100.2 F). His appetite and fluid
  intake are good. Although the child is a little
  bit irritable, he is not lethargic or toxic
  appearing.
• On exam, the TM is dull, but not erythematous,
  and has limited mobility.
• What is your diagnosis, and how should the
  patient be managed?