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

San Carlos Clinical Hospital

Status and phase: Terminated; Phase 4

Conditions: Anxiety

Treatments: Drug: Hydroxyzine; Other: Clowns intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03324828

SONRISA

Details and patient eligibility

About

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

Enrollment: 170 patients

Sex: All

Ages: 2 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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170 participants in 4 patient groups

Hydroxyzine+no clowns

Active Comparator group

Description:

Patients will receive hydroxyzine solution and no additional intervention

Treatment:

Drug: Hydroxyzine

Hydroxyzine+clowns

Experimental group

Description:

Patients will receive hydroxyzine solution and clowns intervention

Treatment:

Other: Clowns intervention

Drug: Hydroxyzine

Placebo+clowns

Active Comparator group

Description:

Patients will receive placebo solution and clowns intervention

Treatment:

Other: Clowns intervention

Placebo+no clowns

No Intervention group

Description:

Patients will receive placebo solution and no additional intervention