E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
POSTERIOR VERTEBRAL FUSION SURGERY IN CHILDREN WITH IDIOPATHIC SCOLIOSIS |
CIRUGÍA DE FUSIÓN VERTEBRAL POSTERIOR EN NIÑOS CON ESCOLIOSIS IDIOPÁTICA |
|
E.1.1.1 | Medical 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.1.1.2 | Therapeutic 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.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036804 |
E.1.2 | Term | Progressive infantile idiopathic scoliosis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main 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.2.2 | Secondary 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.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.4 | Principal 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.5.1 | Primary 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.5.1.1 | Timepoint(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.5.2 | Secondary 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.5.2.1 | Timepoint(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.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial 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.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |