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临床试验/EUCTR2017-000057-40-SE
EUCTR2017-000057-40-SE进行中(未招募)1 期

A prospective randomized double-blind studyIntranasal dexmedetomidine versus intranasal S-ketamine for children age1 – 3 years for procedural sedation and analgesia in pediatric emergencydepartment.

Karolinska University Hospital0 个研究点目标入组 30 人开始时间: 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
入组人数
30

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 1 - 3 years who present to the emergency
  • - A laceration in need of suturing or burn less than 4% of body surface
  • - Weight 10 – 15 kg
  • - Previously healthy
  • - Swedish speaking
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 52
  • 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 12)
  • Current respiratory tract infection
  • Impaired level of consciousness
  • Hypersensitivity for dexmedetomidine or S-ketamine.
  • 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.
  • - advanced heart block (grade 2 or 3) unless paced
  • - uncontrolled hypotension
  • - acute cerebrovascular conditions.

研究者

发起方
Karolinska University Hospital

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