EUCTR2018-004305-11-GB进行中（未招募）1 期
Salbutamol for analgesia in renal colic: A prospective, randomised, placebo controlled Phase II trial - Salbutamol for Analgesia in Renal Colic (SARC) v1.0
niversity Hospitals of Derby & Burton NHS Foundation Trust0 个研究点目标入组 118 人开始时间: 2019年5月24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
- 118
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
入选标准
- •1.Subjects capable of giving informed consent
- •2.Age =18
- •3.Working diagnosis of renal colic, as suggested by severe flank/unilateral abdominal pain, +/- radiating to suprapubic/groin area
- •4.Experiencing severe pain with a requirement for intravenous analgesia
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 118
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Abdominal aortic aneurysm not yet excluded and participant aged =50
- •2.Ectopic pregnancy not yet excluded in a female of child-bearing potential
- •3.Currently actively taking part in another CTIMP
- •4.Previous participant in this trial
- •5.Unable to understand verbal and/or written information in English
- •6.Known allergy to salbutamol
- •7.Evidence of sepsis or clinical suspicion of urinary tract infection
- •8.Serum potassium <3.7mmol/l as measured on point-of-care” venous blood gas
- •9.Concomitant use of: beta blockers (including eye drops); prolonged release opiates; long-acting ß-agonists
- •10.Use of short-acting ß2-agonists within the 6 hours preceding presentation to the emergency department
- •11.Current arrhythmia
- •12.History of any of:
- •ischaemic heart disease
- •arrhythmogenic heart disease
- •valvular heart disease
- •unilateral kidney
- •13.Any other contraindication to the use of salbutamol
研究者
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