EUCTR2016-002890-37-ES进行中（未招募）1 期
Double-blind randomized clinical trial to compare presurgery anxiolysis in children treated with hydroxyzine versus non-pharmacological intervention (distractoria technique clown). - SMILE
Esther Aleo Lujan0 个研究点目标入组 188 人开始时间: 2016年8月5日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 188
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 188
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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, 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.
- •- Pregnancy and lactation.
研究者
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