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    Summary
    EudraCT Number:2020-005409-26
    Sponsor's Protocol Code Number:20200708
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-03-16
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2020-005409-26
    A.3Full title of the trial
    The PREVENT AGITATION trial II – children ≤1 year
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prevention of agitation and pain after anaesthesia in children aged 1 year and below
    A.4.1Sponsor's protocol code number20200708
    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 SponsorCopenhagen University Hospital, Rigshospitalet
    B.1.3.4CountryDenmark
    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 supportCopenhagen University Hospital, Rigshospitalet
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCopenhagen University Hospital, Rigshospitalet
    B.5.2Functional name of contact pointDepartment of Anaesthesiology
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number004535459546
    B.5.5Fax number00453535459546
    B.5.6E-mailbettina.nygaard.nielsen@regionh.dk
    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 Catapres solution for injection 150 mcg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameCatapres
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLONIDINE
    D.3.9.1CAS number 4205-90-7
    D.3.9.4EV Substance CodeSUB06730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 placeboInjection
    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
    Emergence agitation
    E.1.1.1Medical condition in easily understood language
    Agitation after anaesthesia (emergence agitation) is a common complication to anaesthesia in paediatric patients
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10079742
    E.1.2Term Agitation on recovery from sedation
    E.1.2System Organ Class 100000004863
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To describe the pharmacokinetic parameters of clonidine when administered as a single dose intraoperatively
    To evaluate the efficacy of clonidine for prevention of emergence agitation
    E.2.2Secondary objectives of the trial
    To evaluate postoperative pain relief, opioid-sparring effect, postoperative nausea and vomiting, discharge readiness, postoperative feeding, time of awakening and sedations levels in the postanaesthetic care unit
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Paediatric patients, age 3 ≤ 12 months
    • Scheduled for general anaesthesia with sevoflurane and opioid. Induction with propofol is optional
    • The legally acceptable representative for the study participant provides written informed consent/assent for the trial
    E.4Principal exclusion criteria
    • ASA >2
    • Cardiac, neuro and trauma surgery
    • Ex-premature (<37 weeks)
    • Premedication with clonidine
    • Intubated prior to scheduled anaesthesia or is expected to require intubation after the procedure
    • Critical illness incl. hemodynamic instability (inotropic drugs needed)
    • Planned for a postoperative nurse-controlled analgesia pump including a continuous infusion of opioid
    • Bleeding requiring transfusion prior to scheduled anaesthesia
    • Malignant disease
    • Cardiac disease incl. arrhythmia
    • Chronic lung disease that may influence study results or study participation in the opinion of the Investigator or may comprise safety and well-being of the patient
    • Mental retardation
    • Neurological disease including symptoms similar to emergence agitation
    • Has or is suspected of having a family or personal history of malignant hyperthermia
    • Has or is suspected of having an allergy to study treatment or its excipients
    • Any condition that can in opinion of the Investigator, deteriorate safety and well-being of the patients or interfere with pharmacokinetic data
    • Positive Covid-19 test or clinical suspicion of Covid-19 (according to current local guidelines)
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokinetic sampling will be conducted to estimate compartmental Clearance (CL), Volume of distribution (V) and T½

    Emergence agitation measured on the Watcha score (1= calm, 4= agitated and thrashing around)7. The incidence of
    emergence agitation (Watcha score >2 during stay in the postanaesthetic care unit).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Pharmacokinetic end point will be evalutated from dosing to dicharge from the postanaethetic care unit (approx. 0-3 hours post dose)

    Emergence agitation measured on the Watcha score (1= calm, 4= agitated and thrashing around)7. The incidence of
    emergence agitation (Watcha score >2 during stay in the postanaesthetic care unit).
    E.5.2Secondary end point(s)
    1)Assessment of pain intensity by age-appropriate scale (FLACC 0= no pain, 10= worst pain). The proportion of patients with pain intensity score >3 during stay in the postanaesthetic care unit.
    2)The amount of additional opioid needed during stay in the postanaesthetic care unit (calculated as morphine equivalents) for treatment of postoperative pain
    3)Postoperative nausea and vomiting: No validated scale for assessment of PONV exists and PONV will be assessed by nausea/vomiting Yes or No.
    4)Time from arrival in the postanaesthetic care unit to the
    time the patient fulfils local discharge criteria (as judged by physician)
    5)Assessed as the time point the child is eating in the postanaesthetic care unit
    6)Assessed as the time the child is awake. If the child is not awake 2 hours after arrival to the PACU an awakening attempt may be initiated
    7)Assessment of alertness by validated scale (the University of
    Michigan Sedation Scale). Observational 5-point scale ranging from 1(wide awake) to 5(unarousable with deep stimulation)
    8)The number of patients experiencing adverse events
    9)Prespecified events of clinical interest including: Clinically relevant hypotension, clinically relevant bradycardia, and clinically relevant apnoea
    10)24-hour safety follow-up (telephone interview with parents or in-hospital visit, if child is admitted) and
    an additional 48-hour follow-up for patients with ongoing adverse events at the 24-hour safety follow-up
    11)30-day follow-up in the National Patient Registry to assess any subsequent hospital admissions
    E.5.2.1Timepoint(s) of evaluation of this end point
    1)The proportion of patients with pain intensity score >3 during stay in the postanaesthetic care unit.
    2)The amount of additional opioid needed during stay in the postanaesthetic care unit
    3)Postoperative nausea and vomiting during stay in the postanaesthetic care unit.
    4)Time from arrival in the postanaesthetic care unit to the time the patient fulfils local discharge criteria
    5)Assessed as the time point the child is eating in the postanaesthetic care unit
    6)Assessed as the time the child is awake.
    7)Assessment of sedation by validated scale during stay in the postanaesthetic care unit
    8)During the study period
    9)During the study period
    10)Approximately 24 hour post dosing
    11)30 days after dosing
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned1
    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
    LVLS
    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 months4
    E.8.9.1In the Member State concerned days0
    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: 336
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 336
    F.1.1.5Children (2-11years) No
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children aged 3-12 months, the legally acceptable representatives will provide informed consent for participation in the trial
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state336
    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 Decision2021-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-11
    P. End of Trial
    P.End of Trial StatusOngoing
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