Paracetamol-Tramadol and Paracetamol-caffeine Versus Placebo in the Emergency Discharge Treatment of Renal Colic
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Recurrence of RC and ED readmission
研究概览
简要总结
This is a prospective, randomized, single-blind study. Patients included in the study after successful treatment of the acute attack were randomized upon discharge from the Emergency Department into three groups: oral paracetamol-tramadol group, oral paracetamol-caffeine group and oral placebo group.
详细描述
This is a prospective, randomized, single-blind study. Patients included in the study after successful treatment of the acute attack were randomized upon discharge from the Emergency Department into three groups: oral paracetamol-tramadol group, oral paracetamol-caffeine group and oral placebo group.
Different parameters are collected on a standard form prepared for all cases of renal colic included in our study. This sheet essentially contains:
Temperature, systolic and diastolic blood pressure, heart rate, pain intensity assessed by VAS, abdominal tenderness as well as the existence of Giardano signs.
Additional examinations were not systematically carried out for all patients: AUSP, ECBU, renal ultrasound, creatinemia and blood sugar. Their realization depended on the clinical context.
The use of imaging was done following the indications specified in the text of the consensus of the French Society of Emergency Medicine (updated in 2008)
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •-Age > 18 years old.
- •Consent to participate in the study.
- •Pain in the flank/lumbar fossa of sudden onset with urine strips and/or imaging corresponding to the diagnosis of renal colic.
- •Pain score at discharge < 30 (visual analog scale - VAS or verbal numerical scale - VAS from 0 to 100).
排除标准
- •-Inability to appreciate pain according to the VAS.
- •Pregnant or breastfeeding woman.
- •Renal insufficiency with creatinine clearance < 60 ml/min.
研究组 & 干预措施
Paracétamol-tramadol
Each patient received 1 tablet * 2/day synalvic (325 mg of paracetamol + 37.5 mg of tramadol) for 7 days.
干预措施: paracétamol tramadol (Drug)
Paracetamol-caffeine
Each patient received 1 tab * 3/d stopalgic extra (65mgcaffeine+500mg paracetamol) for 7 days
干预措施: Paracétamol cafeine (Drug)
Placebo
Each patient received 1 tab * 3 / d of placebo (flour) every day for 7 days.
*For the three groups, the tablets were packaged hermetically in identical envelopes taken at random to respect double blinding.
干预措施: Placebo (Drug)
结局指标
主要结局
Recurrence of RC and ED readmission
时间窗: 7 day after inclusion
included recurrence of RC and ED readmission within 7-day follow-up
次要结局
- mean time interval(7 day after inclusion)
- side effects(7 days 30 days)
研究者
Pr. Semir Nouira
PROFESSOR
University of Monastir