The Investigation of the Efficacity and Safety of Oral Non Steroidal Anti Inflammatory (NSAI) Drugs Such as Piroxicam as a Second Line Treatment of Patients Consulting the Emergency Departement for Renal Colics.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- Efficacity of oral NSAI (telephone call, asking for the recurrence of pain, the reconsultation rates and intervals and the need for other treatments)
研究概览
简要总结
Outpatients treatment with NSAI in renal colics has not been well investigated and there is no clear recommendations regarding this matter.
The aim of this study is to determine if an oral NSAI treatment is beneficial in patients discharged for the emergency departement after the first line treatment of a renal colic investigating the recurrence of pain, the reconsultation rates and the admissions.
详细描述
Renal colic (RC)are a frequent cause of consultation in the emergency departement (ED).
They count for approximatively 20% of patients presenting to the ED with severe acute onset abdominal pain.
The first line treatment of renal colics is based on NSAI drugs associated with antalgics and is further investigated in the NSAI vs Morphine study (NCT02156596).
But there is no clear recommendations regarding the outpatient treatment of renal colics.
Oral NSAI are still widely used as a second line medicine for this condition and variety of molecules were tried with no solid scientific arguments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years old
- •Consenting to participate in the study
- •Patients treated in the ED for RC
- •No contraindications of NSAI treatment
排除标准
- •Patients excluded from the first phase of the study
- •Contraindication of NSAI treatment
- •Patients non reachable by telephone call
- •Patients that did not receive or use the treatment
研究组 & 干预措施
Oral Piroxicam
Piroxicam : 20 mg per pill; one pill per day for five days associated with placebo (1pill) (taken separately)
干预措施: Piroxicam (Drug)
Placebo
Placebo: two pills per day for five days (taken separately)
干预措施: Placebo (Drug)
paracetamol
paracetamol: 2000mg per day for five days two pills taken separately)
干预措施: paracetamol (Drug)
结局指标
主要结局
Efficacity of oral NSAI (telephone call, asking for the recurrence of pain, the reconsultation rates and intervals and the need for other treatments)
时间窗: seven days
The efficacity of the oral NSAI treatment was evaluated at the seventh day by a telephone call, asking for the recurrence of painand the readmission rates)
次要结局
- Safety of NSAI (telephone call, asking for mean time to recurrence and the occurence of NSAI side effects such as abdominal pain, vomiting, rush, bleeding and ect)(seven days)
研究者
Pr. Semir Nouira
Professor
University of Monastir