EUCTR2013-005201-31-SE进行中（未招募）1 期
Pharmacokinetic profile and pharmacodynamic effects after intranasal naloxone administration in volunteers and pediatric patients. - Intranasal naloxone
Karolinska University Hospital0 个研究点目标入组 20 人开始时间: 2014年8月1日最近更新:
适应症
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
- 20
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
- •In the pharmacokinetic study we are to examine adult healthy volunteers as a first step.
- •In the second phase childen undergoing elective surgery/anesthesia will be given naloxone intranasally and blood sampling will be collected during the peroperative phase. Children, ASA class I and II, age 6 months to 10 years will be included.
- •For the observation part of the study children undergoing painful procedures requiring opioid treatment
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Allergy to nalxone. Parents/children not giving consent.
- •Children less than 6 months and older than 10 years
研究者
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