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

NCT03324828 | Terminated Phase 4

• 1 other identifier: SONRISA
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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

Conditions

Anxiety

Keywords

anxiety; surgery; clown

Outcome Measures

Primary Outcomes (1)

• m-YPAS

  Yale Preoperative Anxiety Scale (mYPAS)

  Anxiety in the operation room (average 60 minutes from the begining of the study)

Secondary Outcomes (4)

• m-YPAS

  Anxiety when the patient arrives at operation room (average 45 minutes from the begining of the study)

• Cortisol level (blood)

  Just before starting surgery (average 75 minutes from the begining of the study)

• Cortisol level (salive)

  when the patient arrives at operation room(average 45 minutes from the begining of the study)

• Anesthesia induction

  Just before starting surgery (average 75 minutes from the begining of the study)

Study Arms (4)

Hydroxyzine+no clowns

ACTIVE COMPARATOR

Patients will receive hydroxyzine solution and no additional intervention

Drug: Hydroxyzine

Hydroxyzine+clowns

EXPERIMENTAL

Patients will receive hydroxyzine solution and clowns intervention

Drug: Hydroxyzine; Other: Clowns intervention

Placebo+clowns

ACTIVE COMPARATOR

Patients will receive placebo solution and clowns intervention

Other: Clowns intervention

Placebo+no clowns

NO INTERVENTION

Patients will receive placebo solution and no additional intervention

Interventions

Hydroxyzine DRUG

Hydroxyzine solution

Hydroxyzine+clowns; Hydroxyzine+no clowns

Clowns intervention OTHER

Clowns intervention

Hydroxyzine+clowns; Placebo+clowns

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead

Study Sites (1)

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Related Publications (2)

• 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.

  PMID: 34805403 DERIVED

• 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.

  PMID: 31898511 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Hydroxyzine

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Esther Aleo Lujan, MD

  Hospital Clinico San Carlos

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Clowns: outcomes assesor Hidroxicine: participant, care provider, investigator and outcomes assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Esther Aleo Lujan, Principal Investigator

Study Record Dates

• First Submitted: October 21, 2017
• First Posted: October 30, 2017
• Study Start: November 1, 2017
• Primary Completion: May 29, 2020
• Study Completion: May 29, 2020
• Last Updated: August 11, 2020

Record last verified: 2020-08

Locations

ES (1)