OBJECTIVETo compare the efficacy and safety of a single ceftriaxone injection with 10-day oral amoxicillin in the treatment for children's acute otitis media.

METHODSThis study was a prospective, comparative, open randomized, multicenter trial. In the ceftriaxone group, a single dose sodium ceftriaxone (50 mg/kg, total dose < 1 g) was injected. In the amoxicillin group, the oral amoxicillin [40 mg/(kg.d), tid] was used for 10 days. Totally 236 cases aged from 0.5 to 12 years were enrolled and 212 cases completed the study. These patients were followed up twice and clinical signs and symptoms were recorded, otoscopy, peripheral blood WBC count, hearing test (pure tone test) and tympanography were performed.

RESULTSIn the ceftriaxone group, 103/106 cases were cured or improved (97.17%), while in the amoxicillin group 96/106 cases were cured or improved (90.57%) (P < 0.05). Ceftriaxone was significantly better than amoxicillin in the treatment. Totally 4 cases had side effects such as papular skin rash, urticaria around mouth, skin pigmentation, two cases in the ceftriaxone group and other two cases in the amoxicillin group. There was no significant difference between the 2 groups in side effects.

CONCLUSIONCeftriaxone injection was significantly better than ten-day oral amoxicillin for treatment of acute otitis media in children. The single dose regimen with ceftriaxone seems to be a good choice for children, particularly for.