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

• Status: Terminated
• Trial end date: 2020-05-29
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital San Carlos, Madrid
• Treatments: Hydroxyzine

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.