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    Summary
    EudraCT Number:2019-004671-39
    Sponsor's Protocol Code Number:2019/318
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2019-12-23
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2019-004671-39
    A.3Full title of the trial
    The effect of handheld-multimedia versus midazolam premedication on the level of perioperative anxiety in pediatric day-care. A randomized controlled trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of tablet-multimedia versus midazolam medication on the level of preoperative anxiety in pediatric day-care.
    A.4.1Sponsor's protocol code number2019/318
    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 SponsorUniversitair Ziekenhuis Brussel (UZ Brussel)
    B.1.3.4CountryBelgium
    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 supportUniversitair Ziekenhuis Brussel (UZ Brussel)
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitair Ziekenhuis Brussel (UZ Brussel)
    B.5.2Functional name of contact pointDepartement of Anesthesie
    B.5.3 Address:
    B.5.3.1Street Addresslaarbeeklaan 101
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1090
    B.5.3.4CountryBelgium
    B.5.4Telephone number0032024749232
    B.5.6E-mailAlex.VanHoorn@uzbrussel.be
    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 Apple Benelux BV
    D.2.1.1.2Name of the Marketing Authorisation holderApple Benelux BV
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameIPAD
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNot mentioned (Noncurrent)
    Other use (Noncurrent)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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) Yes
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeSmart-Tablet in this study the IPAD, from Apple
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Buccolam
    D.2.1.1.2Name of the Marketing Authorisation holderShire Services BVBA
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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.3.4Pharmaceutical form Oromucosal solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMIDAZOLAM HYDROCHLORIDE
    D.3.9.1CAS number 59467-96-8
    D.3.9.4EV Substance CodeSUB03289MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Perioperative anxiety in children scheduled for an elective circumcision, dental care or tonsillectomy/adenoidectomy in day-care
    E.1.1.1Medical condition in easily understood language
    Perioperative anxiety in children scheduled for an elective circumcision, dental care or tonsillectomy/adenoidectomy in day-care
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The goal of this study is, first, to evaluate the need for midazolam-premedication in pediatric day-care patients induced by inhalational anesthesia, and second, to compare the efficacy and safety between anxiolysis by multimedia with an IPAD versus (no anxiolysis) and versus anxiolysis by premedication with midazolam prior to anesthetic-induction.
    Our hypothesis is that Tablet/IPAD distraction could result in equal or better anxiety control in comparison to the standard care with midazolam-premedication.
    The primary endpoint is reduction in level of anxiety perioperative, primarily during induction in children between one and eight years of age in day-care-surgery.


    E.2.2Secondary objectives of the trial
    Secondary objectives are to compare between both trial arms:
    - Anxiety reduction perioperative on daycare, holding and recovery
    - the incidence of stressful anesthetic mask-inductions
    - The incidence of laryngeal spasms or bronchospasm
    - Parental satisfaction
    - parental stress/anxiety level
    - Postoperative anxiety
    - Postoperative POCIS
    - RASS-score evaluation of sedation or possible negative behavior preoperative after midazolam administration
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥ 1 year and <8 years old
    - ASA 1 or 2
    - Elective circumcision, tonsillectomy or adenoidectomy, dental care procedure in day-care
    - Written informed consent by the legal parents or caretaker
    E.4Principal exclusion criteria
    - Parents of the patient wish not to participate with the study
    - Parents are not able to give informed consent (language barrier, legally incapable)
    - A contraindication for the use of premedication with midazolam
    - A known allergy to midazolam
    - A contraindication for premedication in general
    - A contraindication for the use of a gas-induction/gas-anesthesia
    - A contraindication for the use of sevoflurane
    - A known mental retardation of the child
    - Preoperative behavioral disturbances and psychiatric disorders
    - Any use of psychoactive medication
    - A known photosensitive epilepsy
    - A previous operation within 3 months of the time of scheduled operation
    - Any other contraindication for the use of the study medication
    - Previous history of multiple surgery (>3)
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoints are the difference in perioperative anxiety between the two groups measured with mYpas-score and parental-scoring with the 5-point anxiety scale.

    Perioperative anxiety
    The definition peri-anesthetic anxiety until gas-induction will be qualified by scaling using the Short version modified Yale Preoperative Anxiety Scale(mYPAS-SF). The scale is derived from the mYPAS made more practical without any loss of significant clinical information regarding children’s preoperative anxiety. The mYPAS-SF will be scored by trained nurses and anesthesiologists. The mYPAS is validated for children between 1 and 15 years of age. (14) (15) (16) See APPENDIX II

    There will be scored with mYPAS-SF on daycare preoperative and on the holding by the nurse, directly post-induction by the anesthetist or resident and postoperative on the recovery when fully awake.
    A difference of >10 point would be stated as significant conform Marechal et al. (12)
    E.5.1.1Timepoint(s) of evaluation of this end point
    There will be scored with mYPAS-SF on daycare preoperative and on the holding by the nurse, directly post-induction by the anesthetist or resident and postoperative on the recovery when fully awake.
    E.5.2Secondary end point(s)
    - Stressful inductions (anesthetic satisfaction)
    Definition of stressful anesthetic inductions will be qualified by scaling and noted by the anesthesiologist, directly post-induction.

    1. Cooperative Smooth Induction: no crying, no unrest
    2. Passive induction: crying, no unrest
    3. Anxious induction: crying and unrest
    4. Combative induction: total hysteric
    2. Parental scoring for anxiety of the patient

    - Parental scoring for anxiety of the patient will be done by the following the 5-point anxiety scale used:
    1. Happy (playing)
    2. Happy/little worried (playing cautiously)
    3. Worried (no playing, silently)
    4. Anxious (crying)
    5. Hysterical (crying and screaming)
    Parental scoring will be done, on the daycare preoperative, on the holding, postoperative on the recovery.

    - Respiratory postoperative complications
    Scored directly post-induction and post detubation

    - Laryngospasm: Four-point scale (17)
    1. No Laryngospasm
    2. Mild laryngospasm (relieved by jaw thrust and 100% oxygen)
    3. Moderate laryngospasm (relieved by 100% oxygen and positive pressure ventilation)
    4. Severe laryngospasm (relieved by succinylcholine and intubation)

    - Bronchospasm/wheezing
    1. Yes
    2. No
    • In absence of a scale

    - Parental Satisfaction on the anxiety-management perioperative: measured on holding, after induction, recovery, postop daycare unit.
    1. Extremely satisfied
    2. Satisfied
    3. Neutral
    4. Unsatisfied
    5. Extremely Unsatisfactory

    - Postoperative POCIS-Score by leaving the recovery. POCIS is more suitable for young children then the traditional VAS-score (18) See Appendix III of the protocol

    - Preoperative sedation or negative behavior
    Evaluation of sedation or possible negative behavior preoperative after midazolam is done by the RASS-score. (19) See Appendix III of the protocol
    E.5.2.1Timepoint(s) of evaluation of this end point
    There will be scored on daycare preoperative and on the holding by the nurse, directly post-induction by the anesthetist or resident and postoperative on the recovery when fully awake.
    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 Yes
    E.6.5Efficacy Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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
    The end of the study is defined as reaching the requirements of the power analysis. 75 patients per trial arm. 150 patients in total
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    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: 150
    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: 150
    F.1.1.6Adolescents (12-17 years) No
    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 state150
    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
    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 Decision2020-01-23
    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
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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