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Clinical trials for Congenital analgesia

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   44336   clinical trials with a EudraCT protocol, of which   7366   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 ).  
     
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    17 result(s) found for: Congenital analgesia. Displaying page 1 of 1.
    EudraCT Number: 2007-000736-10 Sponsor Protocol Number: Start Date*: 2007-11-05
    Sponsor Name:
    Full Title: A comparison of pethidine/meperidine intramusculary and remifentanil patient-controlled analgesia during labor in Westfriesgasthuis
    Medical condition: Women in labour
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036585 Pregnancy, puerperium and perinatal conditions SOC
    Population Age: Adults Gender: Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-002209-12 Sponsor Protocol Number: ABR59689 Start Date*: 2017-06-21
    Sponsor Name:Erasmus MC-Sophia Children's Hospital
    Full Title: Less opioids after major abdominal surgery in young infants using wound catheter infusion with local anesthetics: a randomized controlled trial.
    Medical condition: Children < 1 year of age undergoing major open abdominal surgery.
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10021298 Ileal atresia PT
    20.1 10010331 - Congenital, familial and genetic disorders 10010526 Congenital large intestinal atresia PT
    20.1 10010331 - Congenital, familial and genetic disorders 10002120 Anal atresia PT
    20.1 10010331 - Congenital, familial and genetic disorders 10010626 Congenital small intestinal atresia PT
    20.1 10010331 - Congenital, familial and genetic disorders 10062022 Intestinal atresia PT
    20.1 10010331 - Congenital, familial and genetic disorders 10013812 Duodenal atresia PT
    20.1 10010331 - Congenital, familial and genetic disorders 10028210 Multiple gastrointestinal atresias PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-005538-23 Sponsor Protocol Number: RB15.213 Start Date*: 2016-02-03
    Sponsor Name:CHRU de Brest
    Full Title: Analgesia and physiotherapy in children with cerebral palsy (ANTALKINECP): Double blind cross-over placebo controlled study of Ibuprofen in children with cerebral palsy undergoing physiotherapy
    Medical condition: Cerebral Palsy
    Disease: Version SOC Term Classification Code Term Level
    18.1 10010331 - Congenital, familial and genetic disorders 10008129 Cerebral palsy PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-005161-20 Sponsor Protocol Number: SCC01 Start Date*: 2012-02-14
    Sponsor Name:University College Dublin Clinical Research Centre
    Full Title: A Randomised Controlled Double-Blind Trial of Intranasal Fentanyl versus Intravenous Morphine in the Emergency Department Treatment of Severe Painful Sickle Cell Crises in Children
    Medical condition: Severe Painful Sickle Cell Disease Crises in Children
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10040644 Sickle cell disease LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IE (Completed)
    Trial results: View results
    EudraCT Number: 2013-001056-35 Sponsor Protocol Number: TXA Start Date*: 2014-11-24
    Sponsor Name:IRCCS Istituto Giannina Gaslini
    Full Title: The Effectiveness and Population Pharmacokinetics and Pharmacogenomics of a Reduced Dose of Tranexamic Acid for Craniosynostosis Surgery: A multicenter study. The TXA Study.
    Medical condition: craniosynostosis
    Disease: Version SOC Term Classification Code Term Level
    17.0 10010331 - Congenital, familial and genetic disorders 10049889 Craniosynostosis PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-005091-26 Sponsor Protocol Number: SANNI-project:02 Start Date*: 2018-02-13
    Sponsor Name:Skåne University Hospital
    Full Title: Clonidine for analgesia to preterm infants during neonatal intensive care – a prospective pharmacokinetic/pharmacodynamic/pharmacogenetic observational study. Cohort 2 in The SANNI project.
    Medical condition: Sick preterm infants undergoing neonatal intensive care.
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-002470-20 Sponsor Protocol Number: SANNI-project:01 Start Date*: 2017-04-11
    Sponsor Name:Skåne University Hospital
    Full Title: Fentanyl and Clonidine for analgesia during hypothermia in term asphyxiated infants – a prospective pharmacokinetic/ pharmacodynamic/ pharmacogenetic observational study. Cohort 1 in The SANNI proj...
    Medical condition: Infants with induced hypothermic treatment after perinatal asphyxia
    Disease:
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-002803-81 Sponsor Protocol Number: TREX Start Date*: 2020-04-03
    Sponsor Name:IRCCS ISTITUTO GIANNINA GASLINI
    Full Title: Neurodevelopmental outcome after standard dose sevoflurane versus low-dose sevoflurane/dexmedetomidine/remifentanil anaesthesia in young children
    Medical condition: Children under the age of 2 years having surgery lasting at least 2 hours
    Disease: Version SOC Term Classification Code Term Level
    21.1 10042613 - Surgical and medical procedures 10018060 General anaesthesia PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-004471-39 Sponsor Protocol Number: IMR-SCD-301 Start Date*: 2020-06-24
    Sponsor Name:IMARA, Inc.
    Full Title: A Phase 2b Study to Evaluate the Safety and Efficacy of IMR-687 in Subjects with Sickle Cell Disease
    Medical condition: Sickle Cell Disease
    Disease: Version SOC Term Classification Code Term Level
    21.0 10010331 - Congenital, familial and genetic disorders 10040644 Sickle cell disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) NL (Prematurely Ended) GR (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-002101-19 Sponsor Protocol Number: CACZ885X2206 Start Date*: 2016-11-22
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multiple-dose, subject- and investigator-blinded, placebo-controlled, parallel design study to assess the efficacy, safety and tolerability of ACZ885 (canakinumab) in pediatric and young adult pa...
    Medical condition: Sickle cell anemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10040641 Sickle cell anaemia PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Completed)
    Trial results: View results
    EudraCT Number: 2020-002945-41 Sponsor Protocol Number: 78464317 Start Date*: 2020-09-24
    Sponsor Name:Lone Nikolajsen
    Full Title: The use of intraoperative methadone in children undergoing open urological surgery
    Medical condition: Postoperative pain in children undergoing open urological surgery
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10031063 Orchiopexy LLT
    20.0 10010331 - Congenital, familial and genetic disorders 10011498 Cryptorchism PT
    20.0 100000004856 10022017 Inguinal hernias HLT
    20.0 10010331 - Congenital, familial and genetic disorders 10020488 Hydrocele PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-002986-21 Sponsor Protocol Number: MST-188-01 Start Date*: 2014-06-16
    Sponsor Name:Mast Therapeutics, Inc.
    Full Title: Evaluation of Purified Poloxamer 188 in Vaso-Occlusive Crisis of Sickle Cell Disease (EPIC): A Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial of MST-188 (purified ...
    Medical condition: Sickle Cell Disease with Vaso-Occlusive Crisis
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004850 10040644 Sickle cell disease LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-004697-25 Sponsor Protocol Number: V528Nov22 Start Date*: 2020-09-14
    Sponsor Name:The Rotunda Hospital
    Full Title: The Home Induction trial: A randomised open-label trial to assess outpatient induction of labour, and compare efficacy of Propess vs Dilapan-S® for induction of labour at 39 weeks’ gestation in nor...
    Medical condition: Normal risk nulliparous women who have no pregnancy-related or medical contraindication to Induction of Labour
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10055563 Labor induction LLT
    Population Age: Adults Gender: Female
    Trial protocol: IE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-000187-15 Sponsor Protocol Number: MK-8616-145 Start Date*: 2017-09-18
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 4 Randomized, Active-Comparator Controlled Clinical Trial to Study the Safety of Sugammadex (MK-8616) for the Reversal of Neuromuscular Blockade Induced by Either Rocuronium Bromide or Vecu...
    Medical condition: Reversal of neuromuscular blockade
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10018061 General anesthesia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2017-001746-10 Sponsor Protocol Number: CSEG101A2301 Start Date*: 2019-07-08
    Sponsor Name:Novartis Pharma AG
    Full Title: A phase III, Multicenter, Randomized, Double-blind Study to Assess Efficacy and Safety of Two Doses of Crizanlizumab versus placebo, with or without Hydroxyurea/ Hydroxycarbamide Therapy, in Adole...
    Medical condition: Sickle Cell Disease with vaso-occlusive crisis
    Disease: Version SOC Term Classification Code Term Level
    21.0 10010331 - Congenital, familial and genetic disorders 10040644 Sickle cell disease PT
    20.1 10010331 - Congenital, familial and genetic disorders 10002077 Anaemia sickle cell LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Trial now transitioned) NL (Trial now transitioned) FR (Trial now transitioned) GR (Completed) DE (Completed) FI (Trial now transitioned) ES (Ongoing) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-001747-12 Sponsor Protocol Number: CSEG101B2201 Start Date*: 2019-05-24
    Sponsor Name:Novartis Pharma AG
    Full Title: A phase 2, Multicenter, Open-Label Study to Assess Appropriate Dosing and to Evaluate Safety of Crizanlizumab, with or without Hydroxyurea/Hydroxycarbamide, in Sequential, Descending Age Groups o...
    Medical condition: Sickle Cell Disease with Vaso-Occlusive Crisis
    Disease: Version SOC Term Classification Code Term Level
    21.0 10010331 - Congenital, familial and genetic disorders 10040644 Sickle cell disease PT
    20.1 10010331 - Congenital, familial and genetic disorders 10002077 Anaemia sickle cell LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) ES (Restarted) FR (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-000188-33 Sponsor Protocol Number: MK-8616-146 Start Date*: 2017-10-27
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 4 Randomized, Active-Comparator Controlled Trial to Study the Efficacy and Safety of Sugammadex (MK-8616) for the Reversal of Neuromuscular Blockade Induced by Either Rocuronium Bromide or ...
    Medical condition: Reversal of neuromuscular blockade
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10018061 General anesthesia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) BE (Completed) AT (Completed)
    Trial results: View results
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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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