E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Presurgery anxiety |
Ansiedad prequirurgica |
|
E.1.1.1 | Medical condition in easily understood language |
Presurgery anxiety |
Ansiedad prequirurgica |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10040760 |
E.1.2 | Term | Situational anxiety |
E.1.2 | System Organ Class | 100000004873 |
|
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 whether the association of pharmacological measures (hydroxyzine) and not pharmacological (distraction by clowns) decreases preoperative anxiety (POA) for children who will be undergoing outpatient surgery. |
Valorar si la asociación de medidas farmacológicas (hidroxicina) y no farmacológicas (distracción por payasos) disminuye la ansiedad preoperatoria (APO) en niños que van a ser intervenidos de cirugía mayor ambulatoria |
|
E.2.2 | Secondary objectives of the trial |
- Develop a validated model of clinical evaluation of presuergery anxiety - To study the effects of reducing presurgery anxiety on the quality perceived by patients and parents |
- Desarrollar un modelo validado de valoración clínica de la APO -Estudiar los efectos de la reducción de la APO sobre la calidad percibida por pacientes y padres |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Children between 2 and 16 years old - Patients with programmed major ambulatory surgery. - Assessment of anesthetic risk ASA I-II. - Informed consent signed by their legal authorized representatives. - No antihistaminic allergies. |
- Niños de entre 2 y 16 años de edad - Pacientes objeto de intervención quirúrgica programada - Valoración de riesgo anestésico ASA I-II. - Consentimiento informado firmado por los tutores legales de los menores. - No alergias constatadas a los antihistamínicos. |
|
E.4 | Principal exclusion criteria |
- Patients with previous surgeries. - Anesthetic risk ASA more than II. - Patients with hypersensitivity to the active substance, to any of the excipients, to cetirizine, to other piperazine derivatives, to aminophylline or etilenamida - Patients with porphyria - Patients with known QT prolongation, either congenital or acquired - Patients with known risk factors for QT prolongation including a pre-existing cardiovascular disease, electrolyte imbalances, family history of sudden cardiac death, significant bradycardia and concomitant use of drugs with potential known to produce QT prolongation and / or induce Torsades de Pointes. - Pregnancy and lactation. |
- Pacientes con antecedentes de cirugías previas, - ASA de riesgo anestésico mayor de II. - Pacientes con hipersensibilidad al principio activo, a alguno de los excipientes, a cetirizina, a otros derivados de la piperazina, a aminofilina o a etilenamida - Pacientes con porfiria - Pacientes con prolongación del intervalo QT conocido, ya sea congénito o adquirido - Pacientes con factores de riesgo conocidos predisponentes para la prolongación del intervalo QT incluyendo una enfermedad cardiovascular preexistente, alteraciones del equilibrio electrolítico, antecedente familiar de muerte súbita cardiaca, bradicardia significativa y uso concomitante de fármacos con potencial reconocido para producir prolongación del intervalo QT y/o inducir Torsade de Pointes. - Embarazo y lactancia. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To assess the effect of distraction with clowns along with the anxiolytic effect of hydroxyzine |
Valorar el efecto de la distracción con payasos junto con el efecto ansiolítico de la hidroxicina |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1. Epidemiological data 2. Assessment of the parental anxiety by STAI questionnaire. 3. Assessment of the state in anesthetic induction 4. Evaluation of the anesthetic recovery by PAEDS scale and valuation of postanesthetic by Aldrete 5. Vital signs: HR, FR. 6. Scales of pain and need for postoperative analgesia. 7. Time to hospital discharge in minutes after the start of surgery. |
1.- Datos epidemiológicos 2.- Valoración de la ansiedad parental mediante cuestionario STAI. 3.- Valoración del estado en la inducción anestésica 4.- Valoración de la recuperación anestésica mediante la escala de PAEDS y valoración de recuperación postanestésica mediante Aldrete 5.- Constantes vitales: FC, FR. 6.- Escalas de dolor y necesidad de analgesia posoperatoria. 7.- Tiempo hasta el alta hospitalaria en minutos tras la salida de quirófano. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1.- Before surgery. 2.- Before surgery. 3.- During surgery. 4.- Postsurgery. 5.- Before, during and after surgery. 6.- Post surgery. 7.- At discharge |
1.- Antes de la cirugía. 2.- Antes de la cirugía. 3.- Durante la cirugía. 4.- Postcirugía . 5.- Antes, durante y después de la cirugía. 6.- Después de la cirugía. 7.- Al alta |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
No farmacologico: terapia con payasos |
Non pharmacological: clowns therapy |
|
E.8.2.4 | Number of treatment arms in the trial | 4 |
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
|
LVLS |
ultima visita ultimo paciente |
|
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 | 7 |
E.8.9.1 | In the Member State concerned days | 0 |