Premarketing surveillance of ibuprofen suppositories in febrile children

Area of Science:

• Pediatrics
• Pharmacology
• Gastroenterology

Background:

• Ibuprofen is commonly used for pediatric fever but often limited to oral forms.
• Novel rectal ibuprofen suppositories offer an alternative administration route.

Purpose of the Study:

• To evaluate parental satisfaction with new ibuprofen suppositories.
• To assess adverse reactions in children treated with ibuprofen suppositories.
• To determine the potential for future use of this medication.

Main Methods:

• A study involving 490 children requiring antipyretic medication in Israeli pediatric wards and clinics.
• Children received ibuprofen suppositories (5-10 mg/kg/dose).
• Parental satisfaction, adverse events, and drug use were recorded over 3-7 days.

Main Results:

• High parental satisfaction reported (4.5 ± 0.47/5).
• 92.2% of parents indicated willingness for future use.
• Adverse reactions were infrequent (1.63%), with diarrhea being the most common.

Conclusions:

• Rectal administration of ibuprofen suppositories is well-tolerated in children.
• High satisfaction and likelihood of repeat use suggest efficacy and acceptance.
• Ibuprofen suppositories represent a viable option for pediatric fever management.