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    Summary
    EudraCT Number:2011-000407-41
    Sponsor's Protocol Code Number:FSJD-ESCOKETA-2010
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-24
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2011-000407-41
    A.3Full title of the trial
    ASSESSMENT OF THE ANALGESIC EFFICACY AND TOLERABILITY OF THE PERIOPERATIVE ASSOCIATION OF KETAMINE WITH OPIATES AFTER POSTERIOR VERTEBRAL FUSION SURGERY IN CHILDREN WITH IDIOPATHIC SCOLIOSIS
    EVALUACIÓN DE LA EFICACIA ANALGÉSICA Y TOLERABILIDAD DE LA ASOCIACIÓN PEROPERATORIA DE KETAMINA CON OPIOIDES, TRAS CIRUGÍA DE FUSIÓN VERTEBRAL POSTERIOR EN NIÑOS CON ESCOLIOSIS IDIOPÁTICA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ASSESSMENT OF THE ANALGESIC EFFICACY AND TOLERABILITY OF THE PERIOPERATIVE ASSOCIATION OF KETAMINE WITH OPIATES AFTER POSTERIOR VERTEBRAL FUSION SURGERY IN CHILDREN WITH IDIOPATHIC SCOLIOSIS
    EVALUACIÓN DE LA EFICACIA ANALGÉSICA Y TOLERABILIDAD DE LA ASOCIACIÓN PEROPERATORIA DE KETAMINA CON OPIOIDES, TRAS CIRUGÍA DE FUSIÓN VERTEBRAL POSTERIOR EN NIÑOS CON ESCOLIOSIS IDIOPÁTICA
    A.4.1Sponsor's protocol code numberFSJD-ESCOKETA-2010
    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 SponsorFUNDACIÓ SANT JOAN DE DEU
    B.1.3.4CountrySpain
    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 supportFondo de Investigación Sanitaria del Instituto de Salud Carlos III.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFUNDACIÓ SANT JOAN DE DEU
    B.5.2Functional name of contact pointFUNDACIÓ SANT JOAN DE DEU
    B.5.3 Address:
    B.5.3.1Street AddressC/Sant Rosa,39-57, 4ª planta, Edificio Docente
    B.5.3.2Town/ cityEsplugas de Llobregat/ Barcelona
    B.5.3.3Post code08950
    B.5.3.4CountrySpain
    B.5.4Telephone number+34936009751
    B.5.5Fax number+34936009771
    B.5.6E-mailrmorales@fjd.org
    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 KETOLAR 50 mg/ml solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderPARKE DAVIS, S.L.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNKETAMINA HIDROCLORURO
    D.3.9.1CAS number 1867-66-9
    D.3.9.3Other descriptive nameKETAMINE HYDROCHLORIDE
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 injection
    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
    POSTERIOR VERTEBRAL FUSION SURGERY IN CHILDREN WITH IDIOPATHIC SCOLIOSIS
    CIRUGÍA DE FUSIÓN VERTEBRAL POSTERIOR EN NIÑOS CON ESCOLIOSIS IDIOPÁTICA
    E.1.1.1Medical condition in easily understood language
    POSTERIOR VERTEBRAL FUSION SURGERY IN CHILDREN WITH IDIOPATHIC SCOLIOSIS
    CIRUGÍA DE FUSIÓN VERTEBRAL POSTERIOR EN NIÑOS CON ESCOLIOSIS IDIOPÁTICA
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10036804
    E.1.2Term Progressive infantile idiopathic scoliosis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the analgesic efficacy of ketamine in the first 72 hours after surgery, measuring the total intake of morphine chloride.
    Valorar la eficacia analgésica de Ketamina en las primeras 72 horas tras la intervención quirúrgica (IQ), midiendo el consumo total de cloruro mórfico.
    E.2.2Secondary objectives of the trial
    ?To assess the analgesic efficacy of the association of Ketamine and opiates after surgery, with pain assessment.
    ?To assess the tolerability of the association of ketamine and opiates after surgery, considering the incidence of adverse effects.
    ?To assess the efficacy of the association of ketamine and opiates after surgery, considering the start of oral tolerance.
    ?To assess the efficacy of the association of ketamine and opiates after surgery, considering the start of deambulation.
    ?To study the efficacy of the combination of ketamine and opiates after surgery; by evaluating duration of hospital stay.
    ?To study the analgesic efficacy of the combination of ketamine and opiates at 72 hours after surgery, by assessing the post-operative hyperalgesic zone.
    ?To study the analgesic efficacy of the combination of ketamine and opiates by considering the incidence of pain 6 weeks after surgery and of chronic pain at 3 and 6 months after surgery.
    ?Estudiar la eficacia analgésica de la asociación de Ketamina a los opioides tras la IQ, valorando el dolor.
    ?Estudiar la tolerabilidad de la asociación de Ketamina a los opioides tras la IQ, valorando la incidencia de efectos adversos.
    ?Estudiar la eficacia de la asociación de Ketamina a los opioides tras la IQ, valorando el inicio de la tolerancia oral.
    ?Estudiar la eficacia de la asociación de Ketamina a los opioides tras la IQ, valorando el inicio de la deambulación.
    ?Estudiar la eficacia de la asociación de Ketamina a los opioides tras la IQ, valorando el tiempo de estancia hospitalaria.
    ?Estudiar la eficacia analgésica de la asociación de Ketamina a los opioides a las 72 horas tras la IQ, valorando la zona de hiperalgesia post-operatoria.
    ?Estudiar la eficacia analgésica de la asociación de Ketamina a los opioides valorando la incidencia de dolor a las 6 semanas tras la IQ y del dolor crónico a los 3 y 6 meses tras la IQ.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a) Patients of both genders diagnosed with idiopathic scoliosis aged between 8 and 18 years old.
    b) Patients of both genders diagnosed with idiopathic scoliosis and candidates for vertebral fusion corrective surgery with instrumentation.
    c) Patients with ASA 1 or ASA 2.
    d) Patients and/or parents/tutors consent to participate in the clinical trial.
    a)Pacientes diagnosticados de escoliosis idiopática de edades comprendidas entre los 8 y 18 años, de ambos géneros.
    b)Pacientes diagnosticados de escoliosis idiopática de ambos géneros y candidatos a cirugía correctora de fusión vertebral con instrumentación.
    c)Pacientes con ASA 1 o ASA 2.
    d)Consentimiento de los pacientes y/o padres / tutores para participar en el ensayo clínico.
    E.4Principal exclusion criteria
    a)Patients with chronic preoperative pain.
    b)Patients with addiction to narcotics.
    c)Patients with a history of allergy, contraindication or intolerance to the drugs used.
    e)Patients unable to understand the patient-controlled analgesia system.
    f)Patients with mental disorders.
    g)Reoperated patients.
    h)Patients requiring elective postoperative ventilation.
    d)Pregnant patients.
    a)Pacientes con dolor crónico preoperatorio.
    b)Pacientes con adicción a los narcóticos.
    c)Pacientes con historia de alergia, contraindicación o intolerancia a los fármacos utilizados.
    e)Pacientes con incapacidad para entender el sistema analgésico controlado por el paciente.
    f)Pacientes con desórdenes mentales.
    g)Pacientes reintervenidos quirúrgicamente.
    h)Pacientes que requieren ventilación postoperatoria electiva.
    d)Pacientes embarazadas.
    E.5 End points
    E.5.1Primary end point(s)
    Total morphine intake during the first 72 hours after the surgical intervention, measured in mg/kg body weight. The total morphine intake is recorded in the PCA infusion pumps.
    Consumo total de morfina durante las primeras 72 horas después de la intervención quirúrgica, medido en mg/Kg peso corporal. El consumo total de morfina queda registrado en las bombas de perfusión PCA.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Intergroup variables of the study will be compared with the following tests: Chi-squared for a comparison of proportions and the Student?s t-test to compare the means and ordinal data.

    In a contrasting hypothesis, a statistically significant difference will be considered to exist between the means (or correlation between variables) when the significance level is below 0.05.
    Para comparar las variables categóricas en función de los dos grupos, se realizará la prueba de Chi-cuadrado. Para el análisis de variables cuantitativas, se utilizará la prueba de t de Student.

    En un contraste de hipótesis, se considerará que existe una diferencia entre medias (o relación entre variables) estadísticamente significativa cuando el nivel de significación sea menor a 0,05.
    E.5.2Secondary end point(s)
    ?Pain assessment by the numerical pain scale in resting state and in movement (coughing) every 4 h after completing post-operative morphine infusion.
    ?Assessment of the incidence of the following adverse effects every 4 hours until completing the post-operative morphine infusion: nausea, vomiting and pruritus, state of sedation, presence of dysphoria, hallucinations, nightmares, diplopia and respiratory depression requiring naloxone.
    ? Post-operative period until start of oral tolerance.
    ? Post-operative period until start of deambulation.
    ? Post-operative period until hospital discharge (post-operative nights of hospital stay).
    ? Measurement of the hyperalgesic zone of the peri-incisional inflamed and non-inflamed skin 72 hours post-surgery and the length of the incision, assessing the mechanical pain threshold by the quantitative sensorial test.
    ?Incidence of pain at 6 weeks and chronic pain at 3 and 6 months post-surgery by the numerical pain scale and the DN4 questionnaire (6 weeks and 6 months).
    ?Valoración del dolor mediante la escala numérica de dolor en reposo y en movimiento (tos) cada 4h hasta finalizar la perfusión de morfina post-operatoria.
    ?Evaluación de la incidencia de los siguientes efectos adversos cada 4h hasta finalizar la perfusión de morfina post-operatoria: náuseas, vómitos y prurito, estado de sedación, presencia de disforia, alucinaciones, pesadillas, diplopía y depresión respiratoria que requiera naloxona.
    ?Tiempo post-operatorio transcurrido hasta el inicio de la tolerancia oral.
    ?Tiempo post-operatorio transcurrido hasta el inicio de la deambulación.
    ?Tiempo post-operatorio transcurrido hasta el alta hospitalaria (noches de ingreso postoperatorio).
    ?Medición de la zona de hiperalgesia de la piel peri-incisional inflamada y no inflamada a las 72 horas post-IQ y longitud de la incisión, evaluando el umbral mecánico del dolor mediante la prueba sensorial cuantitativa.
    ?Incidencia de dolor a las 6 semanas y del dolor crónico a los 3 y 6 meses post-IQ mediante la escala numérica de dolor y el cuestionario DN4 (6 semanas y 6 meses).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Intergroup variables of the study will be compared with the following tests: Chi-squared for a comparison of proportions and the Student?s t-test to compare the means and ordinal data.

    In a contrasting hypothesis, a statistically significant difference will be considered to exist between the means (or correlation between variables) when the significance level is below 0.05.
    Para comparar las variables categóricas en función de los dos grupos, se realizará la prueba de Chi-cuadrado. Para el análisis de variables cuantitativas, se utilizará la prueba de t de Student.

    En un contraste de hipótesis, se considerará que existe una diferencia entre medias (o relación entre variables) estadísticamente significativa cuando el nivel de significación sea menor a 0,05.
    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) 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 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 patient last visit will be the end of the trial
    El final del ensayo coincide con la última visita del último sujeto
    reclutado en el ensayo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 60
    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: 20
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    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 Yes
    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
    Infants less than 11 years old.
    Niños menores de 11 años de edad.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    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)
    Not applicable
    No aplica
    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 Decision2011-07-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-13
    P. End of Trial
    P.End of Trial StatusCompleted
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