Clinical trial to compare anxiety disminution in children treated with hydroxyzine versus clowns.

Phase 1

• Conditions: Presurgery anxiety; MedDRA version: 19.0Level: LLTClassification code 10040760Term: Situational anxietySystem Organ Class: 100000004873; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-002890-37-ES
• Lead Sponsor: Esther Aleo Lujan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-05
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 188

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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 188
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: - Develop a validated model of clinical evaluation of presuergery anxiety<br>- To study the effects of reducing presurgery anxiety on the quality perceived by patients and parents;Primary end point(s): To assess the effect of distraction with clowns along with the anxiolytic effect of hydroxyzine;Timepoint(s) of evaluation of this end point: Presurgery

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Epidemiological data<br>2. Assessment of the parental anxiety by STAI questionnaire.<br>3. Assessment of the state in anesthetic induction<br>4. Evaluation of the anesthetic recovery by PAEDS scale and valuation of postanesthetic by Aldrete<br>5. Vital signs: HR, FR.<br>6. Scales of pain and need for postoperative analgesia.<br>7. Time to hospital discharge in minutes after the start of surgery.;Timepoint(s) of evaluation of this end point: 1.- Before surgery.<br>2.- Before surgery.<br>3.- During surgery.<br>4.- Postsurgery.<br>5.- Before, during and after surgery.<br>6.- Post surgery.<br>7.- At discharge