TY - JOUR
T1 - Intramuscular ceftriaxone compared with oral amoxicillin-clavulanate for treatment of acute otitis media in children
AU - Varsano, I.
AU - Volovitz, B.
AU - Horev, Z.
AU - Robinson, J.
AU - Laks, Y.
AU - Rosenbaum, I.
AU - Cohen, A.
AU - Eilam, N.
AU - Jaber, L.
AU - Fuchs, C.
AU - Amir, J.
N1 - Funding Information:
Acknowledegments We thank the paramedical staff of the primary clinics, Ramat Aviv, Berkman, Plotkin, Yehud and Taibe for their contribution in conducting this study. We also thank Izhak Brook, MD, Department of Infectious Diseases, Naval Hospital, Bethesda, Maryland, USA for his valuable suggestions in editing the manuscript. This work was supported in part by Hoffmann La Roche, Basel Switzerland
PY - 1997
Y1 - 1997
N2 - Two hundred and fifteen children aged 4 months-6 years with acute otitis media (AOM) were randomized to be treated either by a single i.m. injection of ceftriaxone, 50 mg/kg, with a second dose in the event of unsatisfactory response after 48 h or a history of recurrent AOM (109 patients) or amoxicillin clavulanate 12.5 mg tid (106 patients). The failure rate was similar in children treated by ceftriaxone and amoxicillin clavulanate, 4.6% and 4.7%, respectively (standard error for intergroup difference -2.87%, 95% confidence interval -5.62% to 5.87%). No significant differences between the groups were found in the dynamics of the resolution of the acute symptomatology, otoscopy findings, relapse rate at 30 days or tympanographic evidence of middle ear effusion at the scheduled visits on days 30, 60 and 90. Recurrence of AOM between days 31 and 90 was observed significantly in more children treated with amoxicillin clavulanate than with ceftriaxone - 25 out of 84 (29.4%) versus 11 out of 81 (13.6%) (P = 0.012).
AB - Two hundred and fifteen children aged 4 months-6 years with acute otitis media (AOM) were randomized to be treated either by a single i.m. injection of ceftriaxone, 50 mg/kg, with a second dose in the event of unsatisfactory response after 48 h or a history of recurrent AOM (109 patients) or amoxicillin clavulanate 12.5 mg tid (106 patients). The failure rate was similar in children treated by ceftriaxone and amoxicillin clavulanate, 4.6% and 4.7%, respectively (standard error for intergroup difference -2.87%, 95% confidence interval -5.62% to 5.87%). No significant differences between the groups were found in the dynamics of the resolution of the acute symptomatology, otoscopy findings, relapse rate at 30 days or tympanographic evidence of middle ear effusion at the scheduled visits on days 30, 60 and 90. Recurrence of AOM between days 31 and 90 was observed significantly in more children treated with amoxicillin clavulanate than with ceftriaxone - 25 out of 84 (29.4%) versus 11 out of 81 (13.6%) (P = 0.012).
KW - Acute otitis media
KW - Amoxicillin clavulanate
KW - Ceftriaxone
UR - http://www.scopus.com/inward/record.url?scp=0030734316&partnerID=8YFLogxK
U2 - 10.1007/s004310050731
DO - 10.1007/s004310050731
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AN - SCOPUS:0030734316
SN - 0340-6199
VL - 156
SP - 858
EP - 863
JO - European Journal of Pediatrics
JF - European Journal of Pediatrics
IS - 11
ER -