Evaluation of phenoxymethylpenicillin treatment of acute otitis media in children aged 2-16

Objective. To study the clinical recovery from acute otitis media ( AOM) in children, 2-16 years of age, managed with or without treatment with phenoxymethylpenicillin ( PcV). Design. An open, prospective randomized trial. Children aged between 2 and 16 years, presenting with one- or double-sided AOM ( without perforation) with symptom duration of less than four days, were included. The children were randomized to PcV for five days or to no primary antibiotic treatment. A health score and compliance were registered on a daily basis for seven days. Setting. A total of 32 health centres and 72 GPs in south-east Sweden. Subjects. Children aged 2-16 presenting with earache. Main outcome measures. Recovery time, symptom duration, frequency of complications ( up to three months) and consumption of healthcare services independent of treatment with or without antibiotics. Results. A total of 179 patients carried out the trial; 92 were randomized to PcV, 87 to no primary antibiotic treatment. The median recovery time was four days in both groups. Patients who received PcV had less pain ( p<0.001) and used fewer analgesics. There were no significant differences in the number of middle-ear effusions or perforations at the final control after three months. Children randomized to PcV treatment consulted less ( p