Premarketing surveillance of ibuprofen suppositories in febrile children.

Abstract:

:In many countries, ibuprofen is available only in oral formulations. The authors aimed to investigate parental satisfaction and possible adverse reactions among children receiving newly marketed ibuprofen suppositories, prior to their arrival at the pharmaceutical points of distribution. Children needing antipyretic medication were recruited from 11 pediatric wards and clinics in Israel. Each patient received ibuprofen suppositories (5-10 mg/kg/dose) after completing a data collection form. After 3 to 7 days of treatment, information regarding parent satisfaction, possible adverse reactions, and concomitant use of drugs was obtained. Overall, 490 children completed the study. Parents' satisfaction was high (4.5 ± 0.47 on a scale of 1-5), and 92.2% reported that they would use the medication in the future. Adverse reactions were reported in 8 patients (1.63%, 95% confidence interval = 1.77-3.25), the most common being diarrhea. Rectal administration of ibuprofen suppositories is well tolerated and overall satisfaction and the repeated expected use were high.

journal_name

Clin Pediatr (Phila)

journal_title

Clinical pediatrics

authors

Hadas D,Youngster I,Cohen A,Leibovitch E,Shavit I,Erez I,Uziel Y,Berkovitch M

doi

10.1177/0009922810384847

subject

Has Abstract

pub_date

2011-03-01 00:00:00

pages

196-9

issue

3

eissn

0009-9228

issn

1938-2707

pii

0009922810384847

journal_volume

50

pub_type

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