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: 2017年7月3日

适应症

试验速览

暂无简介。

•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

•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.

发起方

Karolinska University Hospital