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TerminatedNCT03324828SONRISAUpdated Aug 11, 2020

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

A Phase 4 interventional study of Hydroxyzine and Clowns intervention in Anxiety, sponsored by Hospital San Carlos, Madrid. Terminated at 1 site in Spain. Open to participants aged 2 Years to 16 Years. Per ClinicalTrials.gov, last updated 2020-08-11.

Sponsored by Hospital San Carlos, Madrid · Phase 4, Interventional, and Treatment

Why this study was terminated
COVID-19
Phase
Phase 4
Study type
Interventional
Enrollment
170
Allocation
Randomized
Ages
2 Years to 16 Years
Sex
All
01

Study 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

02

Conditions studied

  • Anxiety

Keywords

  • anxiety
  • surgery
  • clown
03

Who can participate

Ages eligible
2 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
170 participants (actual)

Study arms

  • Active comparator
    Hydroxyzine+no clowns

    Patients will receive hydroxyzine solution and no additional intervention

    Drug: Hydroxyzine

  • Experimental
    Hydroxyzine+clowns

    Patients will receive hydroxyzine solution and clowns intervention

    Drug: Hydroxyzine · Other: Clowns intervention

  • Active comparator
    Placebo+clowns

    Patients will receive placebo solution and clowns intervention

    Other: Clowns intervention

  • No intervention
    Placebo+no clowns

    Patients will receive placebo solution and no additional intervention

Interventions

  • DrugHydroxyzine

    Hydroxyzine solution

  • OtherClowns intervention

    Clowns intervention

05

What researchers measure

Primary outcomes

  1. m-YPAS

    Yale Preoperative Anxiety Scale (mYPAS)

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

Secondary outcomes

  1. m-YPAS

    Yale Preoperative Anxiety Scale (mYPAS)

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

  2. Cortisol level (blood)

    cortisol blood test

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

  3. Cortisol level (salive)

    cortisol blood test

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

  4. Anesthesia induction

    Anesthesia induction according to the checklist

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

06

Study locations

1 site
  • Hospital Clinico San Carlos
    Madrid, 28040, Spain
07

References and documents

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. PubMed 34805403 ↗
  • 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. PubMed 31898511 ↗
08

Registry details

Key details

Study ID
NCT03324828
Lead sponsor
Hospital San Carlos, Madrid
Responsible party
Esther Aleo Lujan (Esther Aleo Lujan, Principal Investigator, Hospital San Carlos, Madrid) — Principal investigator
First posted
Oct 30, 2017
Start date
Nov 1, 2017
Primary completion
May 29, 2020
Completion
May 29, 2020
Last update
Aug 11, 2020

Study contacts

Esther Aleo Lujan, MD
study chair · Hospital Clinico San Carlos

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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