Presurgery anxiety MedDRA version: 19.0 Level: LLT Classification code 10040760 Term: Situational anxiety System Organ Class: 100000004873
Conditions
Interventions
Trade Name: Atarax
Pharmaceutical Form:
INN or Proposed INN: Hydroxicina
Current Sponsor code: control
Other descriptive name: HYDROXYZINE DIHYDROCHLORIDE
Concentration unit: mg/kg milligram(s)/kilog
Sponsors
Esther Aleo Lujan
Eligibility
Sex/Gender
All
Inclusion 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. 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 - 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
| Measure | Time frame |
|---|---|
| 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.;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 | — |
Countries
Spain
Contacts
Public ContactSponsor
Esther Aleo Lujan
Outcome results
None listed