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

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

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

Study Overview

• Status: Terminated
• Conditions: Anxiety
• Intervention / Treatment: Drug: Hydroxyzine; Other: Clowns intervention

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Hydroxyzine+no clowns; Patients will receive hydroxyzine solution and no additional intervention	Drug: Hydroxyzine; Hydroxyzine solution
EXPERIMENTAL: Hydroxyzine+clowns; Patients will receive hydroxyzine solution and clowns intervention	Drug: Hydroxyzine; Hydroxyzine solution; Other: Clowns intervention; Clowns intervention
ACTIVE_COMPARATOR: Placebo+clowns; Patients will receive placebo solution and clowns intervention	Other: Clowns intervention; Clowns intervention
NO_INTERVENTION: Placebo+no clowns; Patients will receive placebo solution and no additional intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
m-YPAS	Yale Preoperative Anxiety Scale (mYPAS)	Anxiety in the operation room (average 60 minutes from the begining of the study)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital San Carlos, Madrid
• Investigators: Study Chair: Esther Aleo Lujan, MD, Hospital Clinico San Carlos

Publications and helpful links

General Publications

• Aleo E, Picado AL, Abancens BJ, Soto Beauregard C, Tur Salamanca N, Esteban Polonios C, Torrejon MJ, Perrino CG, Rivas A, Arias E, Rodriguez D, Rivas MA, Rojo MLR, Garcia PF, Alarcon JR, San Pedro de Urquiza B. Evaluation of the Effect of Hydroxyzine on Preoperative Anxiety and Anesthetic Adequacy in Children: Double Blind Randomized Clinical Trial. Biomed Res Int. 2021 Nov 11;2021:7394042. doi: 10.1155/2021/7394042. eCollection 2021.
• Aleo Lujan E, Lopez-Picado A, Rivas A, Joyanes Abancens B, Rodriguez Rojo ML, Fernandez Garcia P, Soto Beauregard C, Rodriguez Alarcon J, Gonzalez Perrino C, San Pedro de Urquiza B, Arias E, Rodriguez D, Esteban Polonio C, Torrejon MJ. Pre-operative anxiolysis in children through a combined pharmacological therapy with hydroxyzine and a non-pharmacological distraction technique with a clown (SONRISA): study protocol for randomised double-blind clinical trial. Trials. 2020 Jan 2;21(1):1. doi: 10.1186/s13063-019-3906-2.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2017
• Primary Completion (ACTUAL): May 29, 2020
• Study Completion (ACTUAL): May 29, 2020

Study Registration Dates

• First Submitted: October 21, 2017
• First Submitted That Met QC Criteria: October 26, 2017
• First Posted (ACTUAL): October 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 7, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: surgery; anxiety; clown
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Hydroxyzine
• Other Study ID Numbers: SONRISA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No