NCT04897750已完成2 期
Pharmacokinetic Study of Intranasal CT001 in Children 1-17 Years of Age Undergoing Elective Surgical Procedures.
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Maximum absorption
研究概览
简要总结
This is a prospective non-randomized, open-label, single dose (and a second dose if needed), PK study in 25 children age 1-17 years. The proposed number of study participants by subset is: 8 paediatric participants 1-2 years; 8 paediatric participants >2-6 years and 9 paediatric participants >6-17 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paediatric participants, age 1-17 years at the day of the surgical procedure
- •Planned for elective surgical procedures (e.g. hernia, orchiopexy, gastroscopy, cystoscopy)
- •ASA (American Society of Anaesthesiologists) physical status classification system score 1-2 as determined by investigator
- •Planned for induction of anaesthesia by an intravenous anaesthetic agent, requiring placement of peripheral venous catheter immediately prior to the surgical procedure
- •Needs premedication before induction of anaesthesia as determined by investigator
- •Informed consent by the legally acceptable representative(s)
- •The legally acceptable representative(s) and patients 15-17 years must be able to understand and speak local language
- •A female participant who has onset of menarche is eligible to participate if she is not pregnant, not breastfeeding and agree to follow the contraceptive guidance during the treatment period for at least 7 days after administration of study treatment.
排除标准
- •Ex-premature infant (born <37 weeks AND less than 60 weeks post conceptual age at the day of the surgical procedure)
- •Mental retardation
- •Abnormal nasal cavity or nasal obstruction
- •Clinical contraindications to narcotic analgesia including head injury or any condition that can in the opinion of the investigator, deteriorate safety and well-being of the participants, influence PK data or optimal participation in the trial
- •Medical history including substance or alcohol abuse
- •Has received treatment with sufentanil and/or ketamine during the last 72 hours prior to surgery
- •Has planned perioperative administration of sufentanil and/or ketamine
- •Has or is suspected of having a family or personal history of malignant hyperthermia
- •Has or is suspected of having allergies to ketamine or sufentanil
研究组 & 干预措施
Active
Experimental
a target dose of intranasal sufentanil 0,5 mcg/kg + ketamine 0,5 mg/kg, (2-4 puffs) and an additional dose if needed as premedication before placement of a PVC for induction of anaesthesia.
干预措施: CT001 (Combination Product)
结局指标
主要结局
Maximum absorption
时间窗: 0 - 120 minutes
Peak concentration (Cmax)
Distribution
时间窗: 120 - 240 minutes
Volumen of distribution (Vd)
Elimination
时间窗: 120 - 240 minutes
Half life (T½)
Total absorption over time
时间窗: 0 - 120 minutes
Area under the concentration vs time curve
次要结局
- Analgetic effect(0 - 1 hour)
- Sedation(0 - 1 hour)
- Feasibility, (Acceptance of intranasal administration)(0- 4 hours)
研究者
研究点 (1)
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