Study title: Clinical evaluation of oral transmucosal fentanyl citrate vs. An oral solution of meperidine, diazepam and atropine as a premedication in pediatric patients undergoing cardiovascular surgery
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Anesthesia and Analgesia [E03] | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: FENTANYL | |||||
ATC code: | |||||
Document link: Fentanyl Actiq 100011.xls | |||||
Document date: 2011-09-19 | |||||
Study number: 100/011 | |||||
EudraCT number: | |||||
Scope of study: Clinical | |||||
Population of study subjects: | Preterm newborn Infants | Newborn infants (1 to 27 days) | Infants and toddlers (28 days to 24 months) | Children (2 to 11 years) | Adolescents (12 to 18 years) |
- | - | - | Y | Y |