Presurgery Anxiolysis in Children Treated With Hydroxyzine Versus Non-pharmacological Intervention (Distractoria Technique Clown)

Study Overview
=================
Brief Summary
-----------------
This study evaluate the change in preoperative anxiety, baseline (M1) and pre-induction anxiety levels (M3), as shown by children undergoing MAS determined by the m-YPAS scale in the different APO management groups.Patients will be allocated in one of this four groups: hydroxyzine+clown; hydroxyzine alone, clowns alone or nothing

Official Title
-----------------
Double-blind Randomized Clinical Trial to Compare Presurgery Anxiolysis in Children Treated With Hydroxyzine Versus Non-pharmacological Intervention (Distractoria Technique Clown)

Conditions
-----------------
Anxiety

Intervention / Treatment
-----------------
* Drug: Hydroxyzine
* Other: Clowns intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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. Assent signed by children between 12 and 16 years old. 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, previous 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.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hydroxyzine+no clowns<br>Patients will receive hydroxyzine solution and no additional intervention | Drug: Hydroxyzine<br>* Hydroxyzine solution<br>|
| Experimental: Hydroxyzine+clowns<br>Patients will receive hydroxyzine solution and clowns intervention | Drug: Hydroxyzine<br>* Hydroxyzine solution<br>Other: Clowns intervention<br>* Clowns intervention<br>|
| Active Comparator: Placebo+clowns<br>Patients will receive placebo solution and clowns intervention | Other: Clowns intervention<br>* Clowns intervention<br>|
| No Intervention: Placebo+no clowns<br>Patients will receive placebo solution and no additional intervention | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| m-YPAS | Yale Preoperative Anxiety Scale (mYPAS) | Anxiety in the operation room (average 60 minutes from the begining of the study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| m-YPAS | Yale Preoperative Anxiety Scale (mYPAS) | Anxiety when the patient arrives at operation room (average 45 minutes from the begining of the study) | 
| Cortisol level (blood) | cortisol blood test | Just before starting surgery (average 75 minutes from the begining of the study) | 
| Cortisol level (salive) | cortisol blood test | when the patient arrives at operation room(average 45 minutes from the begining of the study) | 
| Anesthesia induction | Anesthesia induction according to the checklist | Just before starting surgery (average 75 minutes from the begining of the study) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anxiety, surgery, clown