2025-523840-11-00招募中2 期
SETRAPED : A prospective, multicenter study evaluating the efficacy and tolerance of transmucosal midazolam for proportionate palliative sedation in children with refractory symptoms
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 9
- 主要终点
- To describe the efficacy of proportional sedation using transmucosal midazolam in pediatric palliative patients presenting with refractory symptoms
研究概览
简要总结
To describe the efficacy of proportional sedation using transmucosal midazolam in pediatric palliative patients presenting with refractory symptoms
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Age < 18 years at the time of signing informed consent;
- •Female patient of child-bearing potential must be willing to use of a “highly effective” method of contraception from among the following: combined hormonal contraception (estrogen and progesterone) associated with ovulation inhibition (oral, intravaginal, transdermal), hormonal contraception (progesterone only) associated with ovulation inhibition (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinence.
- •Patient in a palliative care situation, followed by a pediatric palliative care team
- •Patient presenting with a refractory symptom, regardless of type;
- •Indication for treatment with midazolam related to the refractory symptom;
- •Absence of a central venous line, or unusable central venous line, or patient refusal to use the line
- •Patient whose parents are able to comply with the study protocol throughout its duration, including data collection
- •Patient affiliated with a national health insurance system
- •Informed consent for participation signed by the parents
- •Patient whose parents agree with the idea that their child might die at home;
排除标准
- •No previous administration of midazolam within 24 hours before the time of midazolam administration in the trial, regardless of the indication for use; Nota Bene: other benzodiazepines are not contraindicated in the study; it will be reported as concomitant medications (Cf. section 6.4 CONCOMITANT TREATMENTS AND DRUG INTERACTION);
- •Patient previously enrolled in the SETRAPED study
- •Pregnant or breastfeeding female patient
- •Known contraindication to oromucosal midazolam (hypersensitivity to benzodiazepines or any excipient of the investigational medicinal product, myasthenia gravis, severe chronic respiratory insufficiency, sleep apnea syndrome, severe hepatic impairment);
- •Parents unable to read and understand French language
研究组 & 干预措施
MIDAZOLAM
Test
干预措施: MIDAZOLAM (Drug)
结局指标
主要结局
To describe the efficacy of proportional sedation using transmucosal midazolam in pediatric palliative patients presenting with refractory symptoms
To describe the efficacy of proportional sedation using transmucosal midazolam in pediatric palliative patients presenting with refractory symptoms
次要结局
未报告次要终点
研究者
Coordinating investigators
Scientific
Centre Leon Berard
研究点 (9)
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