- Trials with a EudraCT protocol (66)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (39)

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: Publication associated to the answer to Swissmedic question following Phenothiazine class group revision. Risks to children from computed tomographic scan premedication. - Mitchell AA, et al.- (J Am Med Assoc 1982; 247(17): 2385-2388.)Publication associated to the answer to Swissmedic question following Phenothiazine class group revision. Risks to children from computed tomographic scan premedication. - Mitchell AA, et al.- (J Am Med Assoc 1982; 247(17): 2385-2388.) |
Active substance: CARBOCYSTEINE AND PROMETHAZINE |
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Document reference: 23349 |
Study title: Effects of anesthetic technique on side effects associated with fentanyl Oralet premedication; Journal of Clinical Anesthesia 1997, 9(5): 374-8 |
Active substance: FENTANYL |
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Document reference: 27144 |
Study title: Clinical evaluation of oral transmucosal fentanyl citrate vs. Placebo as a premedication in children undergoing cardiovascular surgery |
Active substance: FENTANYL |
Study summary document link (including results): Fentanyl Actiq 100013D.xls |
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Document reference: 27112 |
Study title: Clinical evaluation of oral transmucosal fentanyl citrate vs. Placebo as a premedication in children undergoing cardiovascular surgery |
Active substance: FENTANYL |
Study summary document link (including results): Fentanyl Actiq 100006A.xls |
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Document reference: 27114 |
Study title: Clinical evaluation of oral transmucosal fentanyl citrate vs. Placebo as a premedication in children undergoing inpatient orthopedic or urological procedures |
Active substance: FENTANYL |
Study summary document link (including results): Fentanyl Actiq AC100014c.xls |
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Document reference: 27120 |
Study title: Clinical evaluation of three doses of oral transmucosal fentanyl citrate vs. Placebo as premedication in children undergoing inpatient orthopedic, urological or general surgerical procedures |
Active substance: FENTANYL |
Study summary document link (including results): Fentanyl_Actiq_AC100022A.xls |
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Document reference: 27113 |
Study title: Clinical evaluation of two doses of an alternative formulation of oral transmucosal fentanyl citrate (10-15µg/kg and 15-20 µg/kg) as a premedication in pediatric patients undergoing cardiovascular surgery |
Active substance: FENTANYL |
Study summary document link (including results): Fentanyl Actiq AC100016A.xls |
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Document reference: 27121 |
Study title: Clinical evaluation of two doses of an alternative formulation of oral transmucosal fentanyl citrate (5-10 µg/kg and 10-15 µg/kg) as premedication in children undergoing orthopedic procedures |
Active substance: FENTANYL |
Study summary document link (including results): Fentanyl Actiq AC100019.xls |
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Document reference: 27122 |
Study title: Clinical evaluation of two doses of oral transmucosal fentanyl citrate (OTFC) vs. Placebo as a premedication in children |
Active substance: FENTANYL |
Study summary document link (including results): Fentanyl Actiq 100-004 B.xls |
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Document reference: 27109 |
Study title: Comparison of oral transmucosal fentanyl citrate and an oral solution of meperidine, diazepam, and atropine for premedication in children; Anesthesiology 1989, 70(4): 616-621 |
Active substance: FENTANYL |
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Document reference: 27139 |
Study title: Etude du zolpidem et du diazepam en premedication orale avant l'anesthesie generale chez l'enfant - Galperine I. Colle M. Bianchetti G. - 30/08/88 |
Active substance: DIAZEPAM |
Study summary document link (including results): Diazepam STUDY 88-00522-FR-00.xls |
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Document reference: 25936 |
Study title: Martinez JL, Sutters KA, Waite S, Davis J, Medina E, Montano N, Merzel D, Marquez C. A comparison of oral diazepam versus midazolam, administered with intravenous meperidine, as premedication to sedation for pediatric endoscopy. J Pediatr Gastroenterol Nutr. 2002 Jul;35(1):51-8. Martinez JL, Sutters KA, Waite S, Davis J, Medina E, Montano N, Merzel D, Marquez C. A comparison of oral diazepam versus midazolam, administered with intravenous meperidine, as premedication to sedation for pediatric endoscopy. J Pediatr Gastroenterol Nutr. 2002 Jul;35(1):51-8. |
Active substance: DIAZEPAM |
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Document reference: 25944 |
Study title: Fentanyl lollipop - premedication in children |
Active substance: FENTANYL |
Study summary document link (including results): Fentanyl Actiq 100-001 part 1.xls |
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Document reference: 27116 |
Study title: Fentanyl lollipop premedication in children, part II - comparison of a fentanyl lollipop (OTFC) with oral premedication and no premedication |
Active substance: FENTANYL |
Study summary document link (including results): Fentanyl Actiq 100-001 part 2.xls |
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Document reference: 27117 |
Study title: Oral transmucosal fentanyl citrate as an anaesthetic premedication when dosed to an opioid effect vs total opioid consumption; Paediatric Anaesthesia 1998, 8(5): 413-8 |
Active substance: FENTANYL |
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Document reference: 27150 |
Study title: Oral transmucosal fentanyl citrate for premedication of children undergoing laceration repair; Annals of Emergency Medicine 1994, 24(6): 1059-64 |
Active substance: FENTANYL |
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Document reference: 27153 |
Study title: Oral transmucosal fentanyl citrate premedication in children; J Burn Care Rehabil 2002, 23(1): 27-31 |
Active substance: FENTANYL |
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Document reference: 27154 |
Study title: Premedication of pediatric tonsillectomy patients with oral transmucosal fentanyl citrate; Anesthesia and Analgesia 1998, 86(1): 66-70 |
Active substance: FENTANYL |
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Document reference: 27171 |
Study title: The effect of premedication with OTFC, with or without ondansetron, on postoperative agitation, and nausea and vomiting in pediatric ambulatory patients; Paediatric Anaesthesia 2004, 14(9): 759-67 |
Active substance: FENTANYL |
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Document reference: 27183 |
Study title: The effects of oral transmucosal fentanyl citrate premedication on preoperative behavioral responses and gastric volume and acidity in children; Anesthesia and Analgesia 1989, 69(3): 328-35 |
Active substance: FENTANYL |
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Document reference: 27184 |