EUCTR2016-003773-17-SE进行中（未招募）1 期
A prospective randomized open label studyIntranasal dexmedetomidine versus inhaled nitrous oxide for children age 3 – 15 years for procedural sedation and analgesia in pediatric emergency department.
Karolinska University Hospital0 个研究点开始时间: 2017年1月13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
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 at the age of 3 - 15 years who present to the emergency
- •extremity fracture/luxation that require reduction or burn less than 4% of body surface area
- •Previously healthy (ASA I and II)
- •Swedish speaking
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 156
- •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
- •ASA classification = III (see Supplement 11)
- •Current respiratory tract infection
- •Ear infection
- •Pertussis within 6 months
- •Any symptoms of breathing difficulty
- •Active and uncontrolled vomiting
- •Impaired level of consciousness
- •Psychiatric issues
- •Hypersensitivity for dexmedetomidine or N2O.
- •Further contraindications named in the product resume for the trial medicines would categorize the patient as ASA III and therefore not suitable for this trial.
- •oadvanced heart block (grade 2 or 3) unless paced
- •ouncontrolled hypotension
- •oacute cerebrovascular conditions.
研究者
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