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Alejandro Hoberman, MD; Jack L. Paradise, MD; Ellen A. Reynolds, MS, RN; Jacob Urkin, MD

Arch Pediatr Adolesc Med. 1997;151(7):675-678.

Abstract
Objective
To determine the efficacy of Auralgan otic solution (combination product of antipyrine, benzocaine, and glycerin) compared with an olive oil placebo in the management of moderate to severe ear pain in children with acute otitis media (AOM).

Design
Children 5 years or older who presented with ear pain and eardrum findings indicative of AOM were randomly assigned to treatment with Auralgan or olive oil drops instilled into the external auditory canal(s) of the affected ear(s). All children were also treated with 15 mg/kg of acetaminophen in a single dose. Ear pain was assessed by means of 2 visual analog scales—a linear scale and a color scale—at study entry and 10, 20, and 30 minutes later (T₀, T₁₀, T₂₀, and T₃₀, respectively). Results of the measurements on the 2 scales were evaluated independently and were averaged to determine an ear pain score. A baseline ear pain score of at least 3 points was required for study entry. Four outcome measures regarding ear pain score at T₁₀, T₂₀, and T₃₀ were used: (1) proportion of subjects who showed 50% reduction, (2) proportion of subjects who showed 25% reduction, (3) proportion of subjects who showed a 1 or more point reduction, and (4) mean score over time.

Setting
Primary care center and emergency department of a children's hospital.

Participants
Fifty-four children aged 5 to 19 years with ear pain and AOM.

Results
The Auralgan and placebo groups were comparable regarding age, sex, race, laterality of AOM, and T₀ ear pain score. By each of the 4 measures used, the response to treatment consistently favored the Auralgan group, but only at T₃₀ were any differences statistically significant.

Conclusion
In children with AOM-associated ear pain who are treated with acetaminophen, topically applied Auralgan appears likely to provide additional relief in varying degree within 30 minutes.

Arch Pediatr Adolesc Med. 1997;151:675-678

Author Affiliations
From the Department of Pediatrics, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh, Pittsburgh, Pa.

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