Comparative Efficacy of Intramuscular Diclofenac Injection Versus Intravascular Tramadol Injection in Acute Renal Colic, a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Diclofenac 75 mg IM or Tramadol 50 mg IV
研究概览
简要总结
Patients presented with acute pain from renal colic, the standard of care are prescribed NSAIDs, most common drug used is intramuscular (IM) Diclofenac injected at the gluteal muscle. Due to adverse effects in some patients, the nursing council has banned the injection by nurses. Since then, there has been a change in treatment by using intravascular (IV) Tramadol. According to various research, Diclofenac has a higher efficacy in controlling pain compared to other medications. In clinical practice, Tramadol has less efficacy of decreasing pain and a longer onset of action. At presence, there has been no research performed comparing the efficacy between these two drugs especially from the viewpoint of time dimension.
详细描述
To compare the efficacy Diclofenac 75 mg IM versus Tramadol 50 mg IV in patients with acute pain from renal colic.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age over 18 years
- •Acute pain in renal/ureteric colic
- •Pain score more than 4
- •Confirmation diagnosis by ultrasound bedside
排除标准
- •Refused to participate in the research
- •Contraindicated of Diclofenac or Tramadol
- •Urinary tract infection
- •Skin infection at Buttock area
- •Acute kidney injury
- •CKD stage III, IV, V
- •Bilateral severe hydronephrosis
- •Physician refusal
研究组 & 干预措施
Drug1
Diclofenac 75 mg (3 ml) IM injection by doctor, then followed by normal saline 20 ml IV injection (equal to Tramadol diluted) by nurse.
干预措施: Diclofenac/Tramadol (Drug)
Drug2
Normal saline 3 ml IM injection by doctor (equal to Diclofenac 75 mg), then followed by Tramadol 50 mg (1 ml) dilute with normal saline 19 ml (total 20 ml )IV injection by nurse.
干预措施: Diclofenac/Tramadol (Drug)
结局指标
主要结局
Diclofenac 75 mg IM or Tramadol 50 mg IV
时间窗: 30,60,90,120 minutes
Time to pain relief
次要结局
未报告次要终点
研究者
JARUPA YAOWALAORNG
JARUPA YAOWALAORNG
Lampang Hospital