Lornoxicam With Low Dose Ketamine Versus Pethidine to Control Pain of Acute Renal Colic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- No need for more analgesics
研究概览
简要总结
Patients with acute renal colic divided into 2 groups. Group L administered ornoxicam and Group P administered pethidine and VAS was recorded for both groups.
详细描述
Prospective, randomized, double blind clinical study including 120 patients with acute renal pain admitted in emergency department. They were randomly assigned to one of two groups using a computer-generated table. Group L received lornoxicam 8 mg IV plus 0.15 mg.kg-1 ketamine and Group P received pethidine 50 mg IV. Parameters were observed at baseline and after 0, 15, 30, 45 and 1 hour of drug treatment. The efficacy of the drug was measured by observing: patient rated pain, time to pain relief, rate of pain recurrence, the need for rescue analgesia, adverse events and functional status.
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients, who did not administer any analgesics at least within the last two hours. - -
- •Patients aged between 20-60 years.
排除标准
- •Patients with previous renal surgery
- •liver and renal failure
- •hypersensitivity to lornoxicam, ketamine and pethidine, history of peptic ulcer,
- •gastrointestinal bleeding and perforation,
- •hypertensive and history of cardiac diseases
- •pregnancy and lactation and
- •urine examination showing more than 5 leukocytes suggestive of pyuria.
- •patients with hyperthyroidism are excluded
研究组 & 干预措施
Lornixicam
Patients received lornoxicam 8 mg intravenous to control pain
干预措施: Lornoxicam and mepridine (Drug)
Pethidine
Patients received pethidine 50mg intravenous to control pain
干预措施: Lornoxicam and mepridine (Drug)
结局指标
主要结局
No need for more analgesics
时间窗: Registration of analgesic needed for 12h after the attack
Rescue analgesics administration
Change in pain feeling
时间窗: 0hours, 1hour,2hours,3hours,4hours after drug administration in both groups
We assess this through Visual analogue scale score to assess pain due to renal colic, number 10 means maximum pain feeling and 0 means no pain at all.
次要结局
未报告次要终点
研究者
Ayman Anis Metry
Assistant professor
Ain Shams University