Effect of naproxen, a prostaglandin inhibitor, on acute otitis media and persistence of middle ear effusion in children.
Prostaglandins are thought to be of importance in the pathophysiology of otitis media with effusion (OME), and the possibility of reducing the frequency and persistence of this condition by using prostaglandin inhibitors has been suggested. In a double blind manner, naproxen was administered to children with acute otitis media, in addition to amoxicillin, and its influence on the subsequent occurrence and persistence of middle ear effusion was evaluated. Eighty-one children participated in the study. No significant difference was found in the number of patients with tympanograms consistent with OME in the two groups. After 10 days of treatment, 63% in the naproxen and 58% in the placebo group, and after 30 days, 41% and 59%, respectively, had type B tympanograms. Similarly, there were no differences between the two groups with respect to other parameters studied (duration of otalgia, fever, otoscopic findings). No side effects related to naproxen were observed.
Varsano
I B
IB
Department of Pediatrics, Beilinson Medical Center, Petah-Tiqva, Israel.
Volovitz
B M
BM
Grossman
J E
JE
D000208:Acute Disease; D000658:Amoxicillin / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D009288:Naproxen / Q000627:therapeutic use*; D010034:Otitis Media with Effusion / Q000188:drug therapy*; D011448:Prostaglandin Antagonists / Q000627:therapeutic use*; D011897:Random Allocation
D011448:Prostaglandin Antagonists; D009288:Naproxen; D000658:Amoxicillin