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

Phase 4

Terminated

• Conditions: Anxiety
• Interventions: Drug: Hydroxyzine; Other: Clowns intervention

• Registration Number: NCT03324828
• Lead Sponsor: Hospital San Carlos, Madrid

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-21
• Study First Submitted QC: 2017-10-26
• Study First Posted: 2017-10-30
• Study Start: 2017-11-01
• Primary Completion: 2020-05-29
• Study Completion: 2020-05-29
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-07
• Last Update Posted: 2020-08-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 170

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydroxyzine+no clowns	Hydroxyzine	Patients will receive hydroxyzine solution and no additional intervention
Hydroxyzine+clowns	Hydroxyzine	Patients will receive hydroxyzine solution and clowns intervention
Hydroxyzine+clowns	Clowns intervention	Patients will receive hydroxyzine solution and clowns intervention
Placebo+clowns	Clowns intervention	Patients will receive placebo solution and clowns intervention

Primary Outcome Measures

Name	Time	Method
m-YPAS	Anxiety in the operation room (average 60 minutes from the begining of the study)	Yale Preoperative Anxiety Scale (mYPAS)

Secondary Outcome Measures

Name	Time	Method
Cortisol level (blood)	Just before starting surgery (average 75 minutes from the begining of the study)	cortisol blood test
m-YPAS	Anxiety when the patient arrives at operation room (average 45 minutes from the begining of the study)	Yale Preoperative Anxiety Scale (mYPAS)
Cortisol level (salive)	when the patient arrives at operation room(average 45 minutes from the begining of the study)	cortisol blood test
Anesthesia induction	Just before starting surgery (average 75 minutes from the begining of the study)	Anesthesia induction according to the checklist

Trial Locations

Locations (1)

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain