SONRISA: Presurgery Anxiolysis in Children Treated With Hydroxyzine Versus Non-pharmacological Intervention (Distractoria Technique Clown)
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
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
- m-YPAS [Anxiety in the operation room (average 60 minutes from the begining of the study)]
Yale Preoperative Anxiety Scale (mYPAS)
Secondary Outcome Measures
- m-YPAS [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) [Just before starting surgery (average 75 minutes from the begining of the study)]
cortisol blood test
- Cortisol level (salive) [when the patient arrives at operation room(average 45 minutes from the begining of the study)]
cortisol blood test
- Anesthesia induction [Just before starting surgery (average 75 minutes from the begining of the study)]
Anesthesia induction according to the checklist
Eligibility Criteria
Criteria
Inclusion Criteria:
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Children between 2 and 16 years old
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Patients with programmed major ambulatory surgery.
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Assessment of anesthetic risk ASA I-II.
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Informed consent signed by their legal authorized representatives.
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No antihistaminic allergies.
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Assent signed by children between 12 and 16 years old.
Exclusion Criteria:
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Patients with previous surgeries.
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Anesthetic risk ASA more than II.
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Patients with hypersensitivity to the active substance, to any of the excipients, to cetirizine, to other piperazine derivatives, to aminophylline or etilenamida
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Patients with porphyria
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Patients with known QT prolongation, either congenital or acquired
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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.- SONRISA