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Clinical effect of rectal application of suprofen in children. An open controlled study
Insights
Alpha-methyl-4-(2-thienylcarbonyl)-phenyl acetic acid (suprofen) suppositories effectively reduced fever in 85.5% of hospitalized children. This antipyretic medication demonstrated good tolerability with minimal adverse effects observed.
Area of Science:
- Pediatric pharmacology
- Clinical medicine
Background:
- Fever management in children is crucial for comfort and preventing complications.
- Evaluating the efficacy and safety of antipyretic agents in pediatric populations is essential.
Purpose of the Study:
- To assess the antipyretic effect, tolerability, and acceptance of alpha-methyl-4-(2-thienylcarbonyl)-phenyl acetic acid (suprofen) suppositories in hospitalized children.
- To determine the safety profile of suprofen suppositories in a pediatric cohort.
Main Methods:
- An open-label study was conducted on 90 hospitalized children with fever of various etiologies.
- Suprofen suppositories were administered based on body weight, with a maximum of 4 suppositories daily for up to 4 days.
- Rectal temperature, pulse, and respiratory rates were monitored at regular intervals for 6 hours post-administration.
Main Results:
- A statistically significant reduction in body temperature was observed in 85.5% of cases compared to initial values.
- Temperature reduction was significant at all measured time points after the first application, irrespective of sex and age.
- Vomiting was the only adverse reaction reported, occurring in 3 cases.
Conclusions:
- Suprofen suppositories demonstrate significant antipyretic efficacy in hospitalized children.
- The medication is well-tolerated, with a favorable safety profile and minimal adverse events.
- Suprofen suppositories represent a viable option for fever management in pediatric patients.
Abstract:
Antipyretic effect, tolerability, and acceptance of alpha-methyl-4-(2-thienylcarbonyl)-phenyl acetic acid (suprofen, Suprol) suppositories were tested in an open study including 90 hospitalized children with fever of various etiology. The mean rectal temperature prior to treatment was 39.3 degrees C. The dose regimen was chosen depending upon the body weight: Up to 4 suppositories were administered for maximally 4 days. Body temperature as well as pulse and respiratory rates were recorded prior to insertion of the suppository and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 h following first application of the preparation. Regardless of sex and age the temperature was reduced in 85.5% of the cases; as compared to the initial values this reduction was after first application statistically significant at all rating times. The only adverse reaction - vomiting - was seen in 3 cases.