- Trials with a EudraCT protocol (368)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (9)

These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006). | |
Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records. |
Study title: Open label pharmacokinetic and safety evaluation of single iv dose (1,2mg/kg) of dolasetron mesylate in children undergoing elective and uncomplicated surgery under general anesthesia - Howard - 9 February 1995 |
Active substance: DOLASETRON |
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Document reference: 26297 |
Study title: Open label pharmacokinetic and safety evaluation of single oral dose (1,2mg/kg) of dolasetron mesylate in children undergoing elective and uncomplicated surgery under general anesthesia - Keung - 9 February 1995 |
Active substance: DOLASETRON |
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Document reference: 26298 |
Study title: Oral transmucosal fentanyl pretreatment for outpatient general anesthesia; J Anal Toxicol, 2006, 30(8): 603-610 |
Active substance: FENTANYL |
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Document reference: 27156 |
Study title: The pharmacokinetics of the intravenous formulation of fentanyl citrate administered orally in children undergoing general anesthesia; Anesthesia and Analgesia 2004, 99(5): 1347-51 |
Active substance: FENTANYL |
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Document reference: 27185 |
Study title: Study of the efficacy and safety of Ro 15-1788 in reversing the central effects of flunitrazepam used to induce and maintain general anesthesia |
Active substance: FLUNITRAZEPAM |
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Document reference: 28239 |
Study title: To determine wether a modified propofol preparation shows any effect on the incidence of injection pain in children undergoing elective surgery under general anesthesia. |
Active substance: PROPOFOL |
Study summary document link (including results): BBMDE-0312.xls |
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Document reference: 47082 |
Study title: A comparative evaluation of Diprivan (propofol) versus standard anesthetic techniques when administered for the induction and maintenance of general anesthesia in pediatric patients undergoing surgical procedures of one hour or greater duration |
Active substance: PROPOFOL |
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Document reference: 46124 |
Study title: A comparative evaluation of Diprivan /Diprivan N20 versus thiopental/halothane/N20 versus Diprivan/Diprivan when administered for the induction and maintenance of general anesthesia in pedaitric patients undergoing general surgical procedures of one hour or greater duration |
Active substance: PROPOFOL |
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Document reference: 46125 |
Study title: An open-label, multi-center, phase IV study to evaluate the efficacy and safety profiles of sevoflurane in pediatric subjects of different ages undergoing inpatient surgery with general anesthesia |
Active substance: SEVOFLURANE |
Study summary document link (including results): Sevoflurane-CHIN-05-001.pdf |
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Document reference: 42152 |