Double-blind Randomized Clinical Trial to Compare Presurgery Anxiolysis in Children Treated With Hydroxyzine Versus Non-pharmacological Intervention (Distractoria Technique Clown)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- m-YPAS
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Clowns: outcomes assesor Hidroxicine: participant, care provider, investigator and outcomes assessor
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Hydroxyzine+no clowns
Patients will receive hydroxyzine solution and no additional intervention
干预措施: Hydroxyzine (Drug)
Hydroxyzine+clowns
Patients will receive hydroxyzine solution and clowns intervention
干预措施: Hydroxyzine (Drug)
Hydroxyzine+clowns
Patients will receive hydroxyzine solution and clowns intervention
干预措施: Clowns intervention (Other)
Placebo+clowns
Patients will receive placebo solution and clowns intervention
干预措施: Clowns intervention (Other)
结局指标
主要结局
m-YPAS
时间窗: Anxiety in the operation room (average 60 minutes from the begining of the study)
Yale Preoperative Anxiety Scale (mYPAS)
次要结局
- 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))
研究者
Esther Aleo Lujan
Esther Aleo Lujan, Principal Investigator
Hospital San Carlos, Madrid