Clinical trial NCT03324828: Presurgery Anxiolysis in Children Treated With Hydroxyzine Versus Non-pharmacological Intervention (Distractoria Technique Clown)
Official title: Double-blind Randomized Clinical Trial to Compare Presurgery Anxiolysis in Children Treated With Hydroxyzine Versus Non-pharmacological Intervention (Distractoria Technique Clown)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Anxiety
Keywords: anxiety
surgery
clown
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2017-10-30
Enrollment: 170
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: m-YPAS
timeFrame: Anxiety in the operation room (average 60 minutes from the begining of the study)
Secondary outcomes:
measure: m-YPAS
timeFrame: Anxiety when the patient arrives at operation room (average 45 minutes from the begining of the study)
measure: Cortisol level (blood)
timeFrame: Just before starting surgery (average 75 minutes from the begining of the study)
measure: Cortisol level (salive)
timeFrame: when the patient arrives at operation room(average 45 minutes from the begining of the study)
measure: Anesthesia induction
timeFrame: Just before starting surgery (average 75 minutes from the begining of the study)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
Study officials:
affiliation: Hospital Clinico San Carlos
name: Esther Aleo Lujan, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.