Increment Value of Intravenous Dexametasone Versus Nebulized Terbutaline for Renal Colic Pain Management in the Emergency Department: A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Change level of NRS by 50%.
研究概览
简要总结
Adult patients (18-55 years of age) with clinical diagnosis of acute renal colic (sudden sharp colic flank pain with or without radiation to genitalia or groin and with or without urinary symptoms) who had pain score of 5 or more measured by 10-cm visual analogue scale (VAS), will be included. Will be excluded those who had history of cardiovascular, hepatic, renal or metabolic diseases, patients with evidence of sepsis or clinical suspicion of urinary tract infection, hemodynamically unstable patients (systolic blood pressure <90 mmHg), patients with uncontrolled diabetes, pregnancy, breastfeeding, patients unable to understand verbal and/or written information, patients receiving analgesics within 6 hours before presentation, serum potassium less than 3.7 mmol/l, concomitant use of any beta blockers (including beta-blocker containing eye drops), prolonged-release long-acting β-agonists, use of short-acting β2-agonists within the 6 h preceding presentation to the emergency department, any contraindication to the use of terbutaline, history of drug dependence or chronic consumption of alcohol. Will be also excluded patients with known allergy to paracetamol or terbutaline, patients with abdominal tenderness as a sign of peritoneal inflammation and those with any clinical suspicion for diseases other than urolithiasis, including abdominal aortic aneurysm or dissection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-65 years
- •Clinical diagnosis of acute renal colic (defined as sudden sharp colicky flank pain with or without radiation to the genitalia or groin, and with or without urinary symptoms)
- •Pain score of 5 or more measured using the 10-cm NRS scale
排除标准
- •History of cardiovascular, hepatic, renal, or metabolic diseases
- •Evidence of sepsis or clinical suspicion of urinary tract infection
- •Hemodynamically unstable (systolic blood pressure < 90 mmHg)
- •Uncontrolled diabetes
- •Pregnancy or breastfeeding
- •Inability to understand verbal and/or written information
- •Received any analgesics within 6 hours prior to presentation
- •Serum potassium < 3.7 mmol/L
- •Concomitant use of:
- •Any beta-blockers (including beta-blocker-containing eye drops)
- •Prolonged-release long-acting β-agonists
- •Short-acting β2-agonists within 6 hours prior to presentation
- •Contraindication to terbutaline use
- •Known allergy to paracetamol or terbutaline
- •Abdominal tenderness suggestive of peritoneal inflammation
- •Clinical suspicion of conditions other than urolithiasis, including:
- •Abdominal aortic aneurysm
- •Aortic dissection
- •History of drug dependence or chronic alcohol consumption
研究组 & 干预措施
Placebo group
In this group patient will receive 1000mg intravenous injection of paracetamol in combination with 4ml intravenous normal saline as placebo, and 5ml nebulisation of normal saline during 10min.
干预措施: Placebo (Drug)
Dexamethasone group
In this group, patients will receive 1000mg intravenous injection of paracetamol in combination with 4ml intravenous dexamethasone (8mg), and 5ml nebulisation of of normal saline during 10min as placebo.
干预措施: Dexamethasone (Drug)
Terbutaline group
In this group, patients will receive 1000mg intravenous injection of paracetamol in combination with 4ml IV normal saline as placebo, and 5mg Terbutaline in 5ml nebulisation during 10min
干预措施: Terbutaline 2.5 mg (Drug)
结局指标
主要结局
Change level of NRS by 50%.
时间窗: 120 minutes post-intervention
The efficacy of the drug with regards to reducing the Numerical Rating Scale (NRS) A scale from 0 to 10 with 0 meaning "no pain" and 10 meaning "worst imaginable pain."during the follow-up. Criteria for treatment response was determined as pain reduction level by 50% based on the primary NRS score or NRS score of four or lower.
次要结局
- Adverse effects(120 minutes post-intervention)
- Rescue analgesia.(120 minutes post-intervention)
研究者
Pr. Semir Nouira
Professor
University of Monastir
