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 Department for Renal Colics
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Efficacity of oral NSAI
研究概览
简要总结
Treatment with NSAI in renal colics has not been well investigated and there is no clear recommendations regarding this subject.
The aim of this study is to determine if an oral NSAI treatment is beneficial in patients discharged for the emergency department after the first line treatment of a renal colic investigating the reccurence 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). It counts 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 non solid scientific arguments.
Piroxicam, a non-selective COX inhibitor drug appared to the oxicam class of NSAI, is widely used to treat rhumatoid and inflammatory disesases, and often prescribed in Tunisia as a second line treatment of RC.
In this study, the investigators aimed to investigate the efficiency and safety of the use of oral NSAI drugs (piroxicam) compared to Acetaminophen or placebo as a second line treatment of renal colics
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
- Triple (Participant, Care Provider, Investigator)
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 or paracetamol treatment
排除标准
- •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
NSAI
Piroxicam: 20 mg per pill; one pill per day for five days
干预措施: Piroxicam (Drug)
Acetaminophen
Paracetamol: 1000 mg per day for five days
干预措施: Acetaminophen (Drug)
Placebo
Placebo: one pill per day for five days
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacity of oral NSAI
时间窗: 07 days
The efficacity of the oral NSAI treatment was evaluated at the seventh day by a telephone call, asking for the reccurence of pain, the reconsultation rates and intervals and the need for other treatments (antalgics...)
次要结局
- Safety of NSAI(07 days)
研究者
Pr. Semir Nouira
professor
University of Monastir