Tags

Type your tag names separated by a space and hit enter

Efficacy of Auralgan for treating ear pain in children with acute otitis media.
Arch Pediatr Adolesc Med. 1997 Jul; 151(7):675-8.AP

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 seales-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.

Links

Publisher Full Text
Aggregator Full Text

Authors+Show Affiliations

Hoberman A
Department of Pediatrics, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh, Pa., USA. Alejo+@pitt.edu
Paradise JL
No affiliation info available
Reynolds EA
No affiliation info available
Urkin J
No affiliation info available

MeSH

Acute DiseaseAdolescentAdultAntipyrineBenzocaineChildChild, PreschoolDouble-Blind MethodDrug CombinationsFemaleHumansMaleOtitis MediaPainPain MeasurementTreatment Outcome

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

9232040

Citation

Hoberman, A, et al. "Efficacy of Auralgan for Treating Ear Pain in Children With Acute Otitis Media." Archives of Pediatrics & Adolescent Medicine, vol. 151, no. 7, 1997, pp. 675-8.
Hoberman A, Paradise JL, Reynolds EA, et al. Efficacy of Auralgan for treating ear pain in children with acute otitis media. Arch Pediatr Adolesc Med. 1997;151(7):675-8.
Hoberman, A., Paradise, J. L., Reynolds, E. A., & Urkin, J. (1997). Efficacy of Auralgan for treating ear pain in children with acute otitis media. Archives of Pediatrics & Adolescent Medicine, 151(7), 675-8.
Hoberman A, et al. Efficacy of Auralgan for Treating Ear Pain in Children With Acute Otitis Media. Arch Pediatr Adolesc Med. 1997;151(7):675-8. PubMed PMID: 9232040.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of Auralgan for treating ear pain in children with acute otitis media. AU - Hoberman,A, AU - Paradise,J L, AU - Reynolds,E A, AU - Urkin,J, PY - 1997/7/1/pubmed PY - 1997/7/1/medline PY - 1997/7/1/entrez SP - 675 EP - 8 JF - Archives of pediatrics & adolescent medicine JO - Arch Pediatr Adolesc Med VL - 151 IS - 7 N2 - 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 seales-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. SN - 1072-4710 UR - https://www.unboundmedicine.com/medline/citation/9232040/Efficacy_of_Auralgan_for_treating_ear_pain_in_children_with_acute_otitis_media. L2 - https://jamanetwork.com/journals/jamapediatrics/fullarticle/vol/151/pg/675 DB - PRIME DP - Unbound Medicine ER -