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

Overview

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

Full Title of Study: “Double-blind Randomized Clinical Trial to Compare Presurgery Anxiolysis in Children Treated With Hydroxyzine Versus Non-pharmacological Intervention (Distractoria Technique Clown)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 29, 2020

Interventions

  • Drug: Hydroxyzine
    • Hydroxyzine solution
  • Other: Clowns intervention
    • Clowns intervention

Arms, Groups and Cohorts

  • Active Comparator: Hydroxyzine+no clowns
    • Patients will receive hydroxyzine solution and no additional intervention
  • Experimental: Hydroxyzine+clowns
    • Patients will receive hydroxyzine solution and clowns intervention
  • Active Comparator: Placebo+clowns
    • Patients will receive placebo solution and clowns intervention
  • No Intervention: Placebo+no clowns
    • Patients will receive placebo solution and no additional intervention

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.
  • Gender Eligibility: All

    Minimum Age: 2 Years

    Maximum Age: 16 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Hospital San Carlos, Madrid
    • Provider of Information About this Clinical Study
      • Principal Investigator: Esther Aleo Lujan, Esther Aleo Lujan, Principal Investigator – Hospital San Carlos, Madrid
    • Overall Official(s)
      • Esther Aleo Lujan, MD, Study Chair, Hospital Clinico San Carlos

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