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Treatment of acute otitis media in children under 2 years of age

Authors :
Hoberman, A
Paradise, JL
Rockette, HE
Shaikh, N
Wald, ER
Kearney, DH
Colborn, DK
Kurs-Lasky, M
Bhatnagar, S
Haralam, MA
Zoffel, LM
Jenkins, C
Pope, MA
Balentine, TL
Barbadora, KA
Hoberman, A
Paradise, JL
Rockette, HE
Shaikh, N
Wald, ER
Kearney, DH
Colborn, DK
Kurs-Lasky, M
Bhatnagar, S
Haralam, MA
Zoffel, LM
Jenkins, C
Pope, MA
Balentine, TL
Barbadora, KA
Publication Year :
2011

Abstract

Background: Recommendations vary regarding immediate antimicrobial treatment versus watchful waiting for children younger than 2 years of age with acute otitis media. Methods: We randomly assigned 291 children 6 to 23 months of age, with acute otitis media diagnosed with the use of stringent criteria, to receive amoxicillin-clavulanate or placebo for 10 days. We measured symptomatic response and rates of clinical failure. Results: Among the children who received amoxicillin-clavulanate, 35% had initial resolution of symptoms by day 2, 61% by day 4, and 80% by day 7; among children who received placebo, 28% had initial resolution of symptoms by day 2, 54% by day 4, and 74% by day 7 (P = 0.14 for the overall comparison). For sustained resolution of symptoms, the corresponding values were 20%, 41%, and 67% with amoxicillin-clavulanate, as compared with 14%, 36%, and 53% with placebo (P = 0.04 for the overall comparison). Mean symptom scores over the first 7 days were lower for the children treated with amoxicillin-clavulanate than for those who received placebo (P = 0.02). The rate of clinical failure - defined as the persistence of signs of acute infection on otoscopic examination - was also lower among the children treated with amoxicillin-clavulanate than among those who received placebo: 4% versus 23% at or before the visit on day 4 or 5 (P<0.001) and 16% versus 51% at or before the visit on day 10 to 12 (P<0.001). Mastoiditis developed in one child who received placebo. Diarrhea and diaper-area dermatitis were more common among children who received amoxicillin-clavulanate. There were no significant changes in either group in the rates of nasopharyngeal colonization with nonsusceptible Streptococcus pneumoniae. Conclusions: Among children 6 to 23 months of age with acute otitis media, treatment with amoxicillin-clavulanate for 10 days tended to reduce the time to resolution of symptoms and reduced the overall symptom burden and the rate of persistent signs of acut

Details

Database :
OAIster
Notes :
text/plain, English
Publication Type :
Electronic Resource
Accession number :
edsoai.ocn819591807
Document Type :
Electronic Resource