Study of FAECC Scale (Modified FLACC) to Evaluate Ear Pain in Children With Acute Otitis Media

Inclusion Criteria: * The patient has age in the interval 2 months ≤ age \< 5.00 years, signs and symptoms of AOM, and moderate to severe pain (current episode ≤ 2 weeks duration). Moderate to severe pain is defined as a score of \> or = 4 (on a scale of 0 - 10) for the FAECC scale as assessed by the primary assessor. * The patient's parent/guardian must have read and signed the written informed consent prior to study participation. * The patient is normally active and otherwise judged to be in good health on the basis of medical history and limited physical examination. Exclusion Criteria: * Patient has perforated tympanic membrane, history of a perforated tympanic membrane in the last 6 months, or if a perforated tympanic membrane could not be ruled out by speculum examination, impedance testing tympanometry, pneumatic otoscopy, or Valsalva maneuver. Patients who are subsequently diagnosed with a perforated membrane during treatment are to be discontinued immediately. Patients with tympanostomy tubes are not allowed. * Patient has acute or chronic otitis externa. * Patient has chronic otitis media (current episode ≥ 2 weeks). * Patient has seborrheic dermatitis involving the affected external ear canal or pinna. * Patient has received any otic topical or systemic antibiotic within 14 days prior to study entry (topical or systemic antibiotics for acne will be allowed on a chronic basis for subjects who have been on a stable dose for at least 14 days prior to entry). * Pat…