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Clinical trials for Premedication

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44346   clinical trials with a EudraCT protocol, of which   7374   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    Query did not match any clinical trials.
    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.
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    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
    Study summary document link (including results):
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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
    Study summary document link (including results):
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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
    Study summary document link (including results):
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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
    Study summary document link (including results):
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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
    Study summary document link (including results):
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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
    Study summary document link (including results):
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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
    Study summary document link (including results):
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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
    Study summary document link (including results):
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    Document reference: 27184
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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