Open study of the clinical effect of suprofen syrup in children.
The aim of the study was to test the antipyretic effect and the tolerability of alpha-methyl-4-(2-thienyl-carbonyl)phenylacetic acid (suprofen, Suprol) syrup in a sample of pediatric patients with fever of various etiology. The study was designed as an open multiple dose study including 41 hospitalized children (males and females) aged 6 months to 12 years. Temperature, pulse rate, and respiratory rate were measured immediately after consumption of the syrup, after 30 min, 1 h, 1 1/2, 2, 3, 4, 5, and 6 h. The study was performed at one investigational center. At the end of the study, data were evaluated for a total of 41 patients. 27 patients were 5 years or less, 14 patients were 6 to 12 years old. The mean age of the males (23 patients) was 4.5 years; the mean age of the females (18 patients) was 3.8 years. There was no significant sex dependence of the development of temperature, the pulse rate, and the respiratory rate. Prior to treatment the mean temperature was 38.6 degrees C. Temperature decreased to 37.7 degrees C within 1 h and to 37.2 degrees C within 2 h after treatment. From then on, the temperature increased to 37.7 degrees C at the end of the observation period. The decrease in temperature (compared to baseline) was significant throughout the trial. The mean pulse rate decreased from 131.2/min to 119.9/min within 1 h, and to 114.0/min within 2 h. At the end of the trial the mean pulse rate was 120.1/min.(ABSTRACT TRUNCATED AT 250 WORDS)
D001831:Body Temperature / Q000187:drug effects; D002648:Child; D002675:Child, Preschool; D005260:Female; D005334:Fever / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D008297:Male; D010666:Phenylpropionates / Q000627:therapeutic use*; D011674:Pulse / Q000187:drug effects; D012119:Respiration / Q000187:drug effects; D013496:Suprofen / Q000009:adverse effects / Q000627:therapeutic use*
D010666:Phenylpropionates; D013496:Suprofen