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Open study of the clinical effect of suprofen drops in children
Insights
Suprofen (alpha-methyl-4-(2-thienyl-carbonyl)phenylacetic acid) effectively reduced fever in children. This antipyretic medication demonstrated good tolerability and acceptance in an open study.
Area of Science:
- Pediatrics
- Pharmacology
- Clinical Medicine
Background:
- Fever is a common symptom in children requiring effective and safe management.
- Alpha-methyl-4-(2-thienyl-carbonyl)phenylacetic acid (suprofen) is a non-steroidal anti-inflammatory drug (NSAID) with potential antipyretic properties.
Purpose of the Study:
- To evaluate the antipyretic effect of suprofen drops in children with fever.
- To assess the tolerability and acceptance of suprofen drops in a pediatric population.
Main Methods:
- An open-label study was conducted with 111 children experiencing fever of various etiologies.
- Suprofen drops were administered based on body weight and age, up to four times daily for a maximum of four days.
- Rectal temperature, pulse rate, and respiratory rate were monitored at multiple time points post-administration.
Main Results:
- An 89% good appreciation of the antipyretic effect was reported.
- Statistically significant reductions in body temperature were observed at all measured time points after the first dose.
- Adverse drug experiences (vomiting, loose stools) were infrequent (5 cases), with good tolerability (96%) and acceptance (94%) noted.
Conclusions:
- Suprofen drops demonstrated significant efficacy as an antipyretic agent in children.
- The medication was well-tolerated and accepted by the pediatric patients in this study.
- Suprofen represents a potentially valuable option for fever management in children.
Abstract:
Antipyretic effect, tolerability, and acceptance of alpha-methyl-4-(2-thienyl-carbonyl)phenylacetic acid (suprofen, Suprol) drops were tested within the scope of an open study including a total of 111 children with fever of various etiology; two investigational centers participated in this study. The initial mean rectal temperature averaged 39.3 degrees C. The dosage of suprofen drops depended upon the patient's body weight and age; the drug was administered up to q.i.d., for 4 days at the longest. Body temperature, pulse rate, and respiratory rate were recorded prior to administration and 1/2, 1, 1 1/2, 2, 3, 4, 5 and 6 h after first administration of the drug. The antipyretic effect of the treatment was appreciated good in 89% of the cases. Reduction in temperature was statistically significant at all rating times after first administration of the drops as compared with the initial values. Adverse drug experiences such as vomiting and loose stools were seen in only 5 cases. The tolerability was considered good in 96% and the acceptance in 94% of the cases.
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