ISRCTN14552440已完成2 期
Salbutamol for Analgesia in Renal Colic (SARC) v1.0: a prospective, randomised, placebo-controlled Phase II trial
Derby Hospitals NHS Foundation Trust0 个研究点目标入组 148 人开始时间: 2019年7月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 148
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
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
排除标准
- •Current participant exclusion criteria as of 19/02/2020:
- •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
- •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:
- •12.1. Ischaemic heart disease
- •12.2. Arrhythmogenic heart disease
- •12.3. Valvular heart disease
- •12.4. Unilateral kidney
- •13. Any other contraindication to the use of salbutamol
- •Previous participant exclusion criteria:
- •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:
- •12.1. Ischaemic heart disease
- •12.2. Arrhythmogenic heart disease
- •12.3. Valvular heart disease
- •12.4. Unilateral kidney
- •13. Any other contraindication to the use of salbutamol
研究者
相似试验
进行中（未招募）
1 期
Salbutamol for Analgesia in Renal Colic (SARC)Renal colicMedDRA version: 20.1 Level: PT Classification code 10038419 Term: Renal colic System Organ Class: 10038359 - Renal and urinary disordersEUCTR2018-004305-11-GBniversity Hospitals of Derby & Burton NHS Foundation Trust118
已完成
1 期
Pain Control in Renal ColicRenal ColicNCT00646061Seoul National University Hospital
已完成
不适用
An Analgesia Protocol for Acute Renal Colic in the Emergency DepartmentKidney StoneNCT00504283Dartmouth-Hitchcock Medical Center45
撤回
4 期
Pain management in renal colic; The efficacy of continuous intravenous administration of tramadol versus butylscopolamine. A double blinded, randomized placebo controlled, prospective multicenter trial.colic painrenal colic10046708NL-OMON33885Isala Klinieken120
进行中（未招募）
不适用
Pain management in renal colic; The efficacy of continuous intravenous administration of tramadol versus butylscopolamine. A double blinded, randomized placebo controlled, prospective multicenter trial. - TraBu-trialRenal colic pain based on kidney or ureteric stones in patients of 18 years and older.EUCTR2007-006198-98-NLIsala klinieken Zwolle