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临床试验/NCT06980727
NCT06980727尚未招募3 期

Increment Value of Intravenous Dexametasone Versus Nebulized Terbutaline for Renal Colic Pain Management in the Emergency Department: A Randomized Clinical Trial

University of Monastir1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2026年8月8日最近更新:
干预措施
相关药物

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

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

Placebo Comparator

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

Active Comparator

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pr. Semir Nouira

Professor

University of Monastir

研究点 (1)

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