Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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   43871   clinical trials with a EudraCT protocol, of which   7290   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.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-000314-38
    Sponsor's Protocol Code Number:PSS2018/DEXPED-MEISTELMAN/YB
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2018-06-07
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2018-000314-38
    A.3Full title of the trial
    Efficiency of IV dexamethasone compared to placebo, administrated after a lower limb blockade is done, on the post operative pain in children : a controled, randomised, double blind study.
    Efficacité de la dexamethasone IV, comparativement au placebo, administrée au moment de la réalisation d'un bloc antalgique du membre inférieur, sur la douleur post-opératoire chez l'enfant : essai contrôlé, randomisé en double aveugle
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficiency of dexamethasone, administrated just before the lower limb nerve blockade, on the decrease of post operative pain in children
    Efficacité de la dexaméthasone, administrée juste avant la réalisation de l'anesthésie des nerfs du membre inférieur, sur la diminution de la douleur après l'opération chez l'enfant.
    A.3.2Name or abbreviated title of the trial where available
    DEXPED
    DEXPED
    A.4.1Sponsor's protocol code numberPSS2018/DEXPED-MEISTELMAN/YB
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCHRU de NANCY
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCHRU de Nancy
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHRU de Nancy
    B.5.2Functional name of contact pointDirection Recherche et Innovation
    B.5.3 Address:
    B.5.3.1Street AddressBâtiment Recherche - Rue du Morvan
    B.5.3.2Town/ cityVandoeuvre-lès-Nancy
    B.5.3.3Post code54511
    B.5.3.4CountryFrance
    B.5.4Telephone number3338315 5285
    B.5.5Fax number33383157451
    B.5.6E-mailrechclin-innov@chru-nancy.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name DEXAMETHASONE MYLAN
    D.2.1.1.2Name of the Marketing Authorisation holderMYLAN
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDEXAMETHASONE MYLAN
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    post operative pain
    douleur post opératoire
    E.1.1.1Medical condition in easily understood language
    post operative pain
    douleur après l'opération
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10002182
    E.1.2Term Analgesia
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the efficiency of 0,2mg/kg IV dexamathasone administrated at anesthesia induction compared to placebo, on the decrease of post operative pain in children from 6 to 15 who are qualified for a lower limb surgery with a loco-regional anesthesia
    Evaluer l’efficacité, comparativement au placebo, de la dexaméthasone IV à la dose de 0,2mg/kg administrée en bolus au moment de l’induction anesthésique, sur la douleur post opératoire précoce (24 premières heures) chez l’enfant de 6 à 15 ans bénéficiant d’une intervention chirurgicale qui nécessite la réalisation d’un bloc péri-nerveux du membre inférieur.
    E.2.2Secondary objectives of the trial
    - Evaluate the efficiency of 0,2mg/kg IV dexamathasone administrated at anesthesia induction compared to placebo, on the increase of the delay of first post operative morphinic consumption in children from 6 to 15 who are qualified for a lower limb surgery with a loco-regional anesthesia.
    - Evaluate that 0,2mg/kg IV dexamathasone administrated at anesthesia induction compared to placebo, doesn't increase the lower limb motor blokade duration in children from 6 to 15 who are qualified for a lower limb surgery with a loco-regional anesthesia
    - Evaluate the efficiency of 0,2mg/kg IV dexamathasone administrated at anesthesia induction compared to placebo, on the decrease of post operative nausea and vomiting in children from 6 to 15 who are qualified for a lower limb surgery with a loco-regional anesthesia
    - Evaluer l’effet de l’administration de Dexaméthasone 0,2mg/kg, administrée en IV bolus au moment de l’induction anesthésique, sur le délai post-opératoire de survenue de la douleur, chez l’enfant de 6 à 15 ans bénéficiant d’une intervention chirurgicale qui nécessite la réalisation d’un bloc péri-nerveux du membre inférieur
    - Evaluer l’effet de l’administration de Dexaméthasone, 0,2mg/kg administrée en IV bolus au moment de l’induction anesthésique, n'augmente pas significativement la durée du bloc moteur chez l’enfant de 6 à 15 ans bénéficiant d’une intervention chirurgicale qui nécessite la réalisation d’un bloc péri-nerveux du membre inférieur
    - Evaluer l’effet de l’administration de Dexaméthasone, 0,2mg/kg en IV bolus au moment de l’induction anesthésique, sur les nausées / vomissements dans les 24 heures post-opératoire, chez l’enfant de 6 à 15 ans bénéficiant d’une intervention chirurgicale qui nécessite la réalisation d’un bloc péri-nerveux du membre inférieur
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Children from 6 to 15 who are qualified for a lower limb surgery with a loco-regional anesthesia with an anesthesic consultation between 90 to 2 days before the surgery
    - legal guardian agreement
    - Children who are affiliated to the social security
    - Information of minor subjects adapted to their ability to understand
    - Enfants de 6 à 15 ans devant bénéficier d’une chirurgie pour laquelle un bloc péri-nerveux du membre inférieur à visée antalgique est indiqué et bénéficiant d’une consultation anesthésique entre J-90 et J-2 par rapport à l’intervention
    - Consentement des tuteurs légaux
    - Information des sujets mineurs adaptés à leur capacité de compréhension
    - Personne affiliée à un régime de sécurité sociale ou bénéficiaire d’un tel régime
    E.4Principal exclusion criteria
    - Children who presents a contraindication to the single shot IV dexamethasone
    - septic surgery
    - diabetes
    - corticoid treatment in the 7 days before the surgery
    - outpatient surgery
    - handicapped or impaired children
    - pei-nerval catheter
    - Children who are privated from their liberty because of a court or administrative decision or need psychiatric care
    - uncontrolled psychotic state
    - Personne présentant une contre-indication à l’utilisation de la dexaméthasone en injection unique
    - Intervention septique
    - Antécédent de diabète
    - Traitement préalable par corticoïdes par voie générale au cours des 7 jours précédant l’intervention
    - Chirurgie ambulatoire
    - Handicaps ou retards mentaux empêchant l’auto-évaluation de la douleur
    - Pose d'un cathéter péri-nerveux
    - Personnes visées aux articles L.1121-5 à L.1121-8 et L.122-2 du Code de la Santé Publique : -personne privée de liberté par une décision judiciaire ou administrative -personne faisant l'objet de soins psychiatriques en vertu des articles L.3212-1 et L.3213-1 du Code de la Santé Publique.
    - état psychotique non contrôlé
    E.5 End points
    E.5.1Primary end point(s)
    Morphinic consumption in the post operative 24H
    Consommation totale de morphinique dans les 24h post opératoire
    E.5.1.1Timepoint(s) of evaluation of this end point
    during the post operative 24h
    Dans les 24h post opératoire
    E.5.2Secondary end point(s)
    - delay between the realisation of the lower limb blockade ans the first -
    consumption of morphinic
    - duration the the motor blockade
    - prevalence of post opérative nausea/vomiting
    - Délai entre réalisation du bloc (anesthésie loco-régionale) et première consommation de morphiniques
    - Durée du bloc moteur (score de Bromage)
    - Prévalence des nausées/vomissements post opératoires
    E.5.2.1Timepoint(s) of evaluation of this end point
    during the post operative 24h
    during the post operative 24h
    during the post operative 24h
    Dans les 24h post opératoire
    Dans les 24h post opératoire
    Dans les 24h post opératoire
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit of last patient
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 80
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 50
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Non applicable
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-07-18
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri May 03 02:26:33 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA