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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2020-05-29

Brief Summary

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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

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Detailed Description

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Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Clowns: outcomes assesor Hidroxicine: participant, care provider, investigator and outcomes assessor

Study Groups

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Hydroxyzine+no clowns

Patients will receive hydroxyzine solution and no additional intervention

Group Type ACTIVE_COMPARATOR

Hydroxyzine

Intervention Type DRUG

Hydroxyzine solution

Hydroxyzine+clowns

Patients will receive hydroxyzine solution and clowns intervention

Group Type EXPERIMENTAL

Hydroxyzine

Intervention Type DRUG

Hydroxyzine solution

Clowns intervention

Intervention Type OTHER

Clowns intervention

Placebo+clowns

Patients will receive placebo solution and clowns intervention

Group Type ACTIVE_COMPARATOR

Clowns intervention

Intervention Type OTHER

Clowns intervention

Placebo+no clowns

Patients will receive placebo solution and no additional intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hydroxyzine

Hydroxyzine solution

Intervention Type DRUG

Clowns intervention

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No