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

Sponsor
Hospital San Carlos, Madrid (Other)
Overall Status
Terminated
CT.gov ID
NCT03324828
Collaborator
(none)
170
Enrollment
1
Location
4
Arms
30.9
Actual Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
170 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Clowns: outcomes assesor Hidroxicine: participant, care provider, investigator and outcomes assessor
Primary Purpose:
Treatment
Official Title:
Double-blind Randomized Clinical Trial to Compare Presurgery Anxiolysis in Children Treated With Hydroxyzine Versus Non-pharmacological Intervention (Distractoria Technique Clown)
Actual Study Start Date :
Nov 1, 2017
Actual Primary Completion Date :
May 29, 2020
Actual Study Completion Date :
May 29, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. m-YPAS [Anxiety in the operation room (average 60 minutes from the begining of the study)]

    Yale Preoperative Anxiety Scale (mYPAS)

Secondary Outcome Measures

  1. m-YPAS [Anxiety when the patient arrives at operation room (average 45 minutes from the begining of the study)]

    Yale Preoperative Anxiety Scale (mYPAS)

  2. Cortisol level (blood) [Just before starting surgery (average 75 minutes from the begining of the study)]

    cortisol blood test

  3. Cortisol level (salive) [when the patient arrives at operation room(average 45 minutes from the begining of the study)]

    cortisol blood test

  4. Anesthesia induction [Just before starting surgery (average 75 minutes from the begining of the study)]

    Anesthesia induction according to the checklist

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 16 Years
Sexes Eligible for Study:
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:

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Clinico San Carlos Madrid Spain 28040

Sponsors and Collaborators

  • Hospital San Carlos, Madrid

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Esther Aleo Lujan, Esther Aleo Lujan, Principal Investigator, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier:
NCT03324828
Other Study ID Numbers:
  • SONRISA
First Posted:
Oct 30, 2017
Last Update Posted:
Aug 11, 2020
Last Verified:
Aug 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Esther Aleo Lujan, Esther Aleo Lujan, Principal Investigator, Hospital San Carlos, Madrid
anxiety
surgery
clown
Additional relevant MeSH terms:
Hydroxyzine

Study Results

No Results Posted as of Aug 11, 2020