Co-amoxiclav in recurrent acute otitis media: placebo controlled study.
OBJECTIVE
To determine the efficacy of coamoxiclav in children aged 6 months to 12 years with recurrent acute otitis media.


METHODS
A randomised double blind placebo controlled clinical trial.


METHODS
General practice in the Netherlands.


METHODS
121 children with recurrent acute otitis media, defined by onset of otalgia and otoscopic signs of middle ear infection within four to 52 weeks after the previous attack. Confirmation of diagnosis and randomisation was done by otolaryngologists.


METHODS
Oral co-amoxiclav or placebo in weight related doses for seven days.


METHODS
An irregular clinical course defined as the presence of otalgia or a body temperature greater than or equal to 38 degrees C, or both, after three days.


RESULTS
Eleven (16%; 95% confidence interval 9% to 28%) children had an irregular course in the co-amoxiclav group and 10 (19%; 9% to 31%) in the placebo group (difference not significant). Age, dichotomised at 2 years, was the only significant prognostic factor for irregular course of the disease (odds ratio 5.9; 1.8 to 19.1). Among children aged below 2 years, 28% (4/14) in the co-amoxiclav group and 58% (7/12) in the placebo group had irregular courses. For children 2 years and older these percentages were 13% (7/52) and 7% (3/41).


CONCLUSIONS
Children with recurrent acute otitis media are at greater risk of an irregular clinical course of the disease than children with a first episode of acute otitis media. Co-amoxiclav has no significant benefit over placebo in treating children over 2 years with acute otitis media.
Appelman
C L
CL
Department of General Practice, University of Utrecht, The Netherlands.
Claessen
J Q
JQ
Touw-Otten
F W
FW
Hordijk
G J
GJ
de Melker
R A
RA
D000208:Acute Disease; D000367:Age Factors; D000658:Amoxicillin / Q000627:therapeutic use*; D019980:Amoxicillin-Potassium Clavulanate Combination; D002648:Child; D002675:Child, Preschool; D002969:Clavulanic Acids / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010033:Otitis Media / Q000188:drug therapy*; D011379:Prognosis; D012008:Recurrence
D002969:Clavulanic Acids; D019980:Amoxicillin-Potassium Clavulanate Combination; D000658:Amoxicillin