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

Anxiety Clinical Trial

— SONRISA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03324828
• Other study ID #: SONRISA
• Status: Terminated
• Phase: Phase 4
• Start date: November 1, 2017
• Est. completion date: May 29, 2020

Study information

• Verified date: August 2020
• Source: Hospital San Carlos, Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 170
• Est. completion date: May 29, 2020
• Est. primary completion date: May 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety

Intervention

Drug:
• Hydroxyzine
Hydroxyzine solution

Other:
• Clowns intervention
Clowns intervention

Locations

Country	Name	City	State
Spain	Hospital Clinico San Carlos	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital San Carlos, Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	m-YPAS	Yale Preoperative Anxiety Scale (mYPAS)	Anxiety in the operation room (average 60 minutes from the begining of the study)
Secondary	m-YPAS	Yale Preoperative Anxiety Scale (mYPAS)	Anxiety when the patient arrives at operation room (average 45 minutes from the begining of the study)
Secondary	Cortisol level (blood)	cortisol blood test	Just before starting surgery (average 75 minutes from the begining of the study)
Secondary	Cortisol level (salive)	cortisol blood test	when the patient arrives at operation room(average 45 minutes from the begining of the study)
Secondary	Anesthesia induction	Anesthesia induction according to the checklist	Just before starting surgery (average 75 minutes from the begining of the study)