Double-blind Randomized Clinical Trial to Compare Presurgery Anxiolysis in Children Treated With Hydroxyzine Versus Non-pharmacological Intervention (Distractoria Technique Clown)
Overview
- Phase
- Phase 4
- Intervention
- Hydroxyzine
- Conditions
- Anxiety
- Sponsor
- Hospital San Carlos, Madrid
- Enrollment
- 170
- Locations
- 1
- Primary Endpoint
- m-YPAS
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
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
Investigators
Esther Aleo Lujan
Esther Aleo Lujan, Principal Investigator
Hospital San Carlos, Madrid
Eligibility Criteria
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.
Arms & Interventions
Hydroxyzine+no clowns
Patients will receive hydroxyzine solution and no additional intervention
Intervention: Hydroxyzine
Hydroxyzine+clowns
Patients will receive hydroxyzine solution and clowns intervention
Intervention: Hydroxyzine
Hydroxyzine+clowns
Patients will receive hydroxyzine solution and clowns intervention
Intervention: Clowns intervention
Placebo+clowns
Patients will receive placebo solution and clowns intervention
Intervention: Clowns intervention
Outcomes
Primary Outcomes
m-YPAS
Time Frame: Anxiety in the operation room (average 60 minutes from the begining of the study)
Yale Preoperative Anxiety Scale (mYPAS)
Secondary Outcomes
- Cortisol level (blood)(Just before starting surgery (average 75 minutes from the begining of the study))
- m-YPAS(Anxiety when the patient arrives at operation room (average 45 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))