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Open study of the clinical effect of suprofen syrup in children
Insights
Suprofen (Suprol) syrup effectively reduced fever in pediatric patients. This antipyretic medication demonstrated significant temperature reduction and good tolerability in children aged 6 months to 12 years.
Area of Science:
- Pediatric Pharmacology
- Clinical Therapeutics
- Pharmacodynamics
Background:
- Fever is a common symptom in pediatric patients, necessitating effective and safe antipyretic treatments.
- Suprofen, a non-steroidal anti-inflammatory drug, has been investigated for its antipyretic properties.
Purpose of the Study:
- To evaluate the antipyretic efficacy of alpha-methyl-4-(2-thienyl-carbonyl)phenylacetic acid (suprofen, Suprol) syrup.
- To assess the tolerability of suprofen syrup in pediatric patients with fever.
Main Methods:
- An open-label, multiple-dose study was conducted with 41 hospitalized children (6 months to 12 years).
- Vital signs including temperature, pulse rate, and respiratory rate were monitored at multiple intervals up to 6 hours post-administration.
- Data from 41 patients were analyzed, with subgroups based on age (≤5 years and 6-12 years).
Main Results:
- Suprofen syrup significantly reduced mean body temperature from a baseline of 38.6°C to 37.7°C within 1 hour and 37.2°C within 2 hours.
- The temperature reduction was statistically significant throughout the 6-hour observation period.
- Mean pulse rate decreased from 131.2/min to 114.0/min within 2 hours, with a final mean pulse rate of 120.1/min.
Conclusions:
- Suprofen syrup exhibits significant antipyretic effects in pediatric patients.
- The medication was well-tolerated in the studied pediatric population.
- Suprofen represents a viable option for managing fever in children.
Abstract:
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)