Patients Undergoing Routine Transcutaneous Electrical Nerve Stimulation Treatment in Patients With Renal Colic Who Admitted to the Emergency Department: A Randomized Double Blind Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Reduction of the intensity of pain
研究概览
简要总结
The aim of the present trial was to investigate the analgesic efficacy and safety of Transcutaneous electrical nerve stimulation treatment in patients with renal colic within the emergency department.
详细描述
Renal colic, an intensely painful condition, is a common presenting complaint to the emergency department. Parenteral opioids, nonsteroidal anti-inflammatory drugs and acetaminophen are commonly used to provide relief from renal colic. The aim of the present trial was to investigate the analgesic efficacy and safety of Transcutaneous electrical nerve stimulation treatment in patients with renal colic within the emergency department.
Study Design and Setting: A prospective, randomized, double-blind, placebo controlled, single-center, clinical trial will be conducted in emergency department of a tertiary care university hospital.
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 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with renal colic admitted to emergency department.
- •Adult patients who were definitively diagnosed with acute renal colic due to urinary system stones using unenhanced computed abdominopelvic tomography
排除标准
- •Patients below 18 years of age
- •Patients with haemodynamic instability, with fever (temperature=38°C [100.4°F]), with evidence of peritoneal inflammation,
- •Patients using any analgesic within the previous 48 hours of emergency department presentation
- •Patients who declined to participate
研究组 & 干预措施
TENS
Patients receiving the real transcutaneous electrical nerve stimulation (TENS) with 100 hertz, pulse width 200 microseconds, voltage 2 milliampere
干预措施: TENS (Device)
placebo group
Patients receiving the application of transcutaneous electrical nerve stimulation, but transcutaneous electrical nerve stimulation will not be activated.
干预措施: placebo group (Device)
结局指标
主要结局
Reduction of the intensity of pain
时间窗: 0 minutes, 15 minutes and 30 minutes after taking Transcutaneous Electrical Nerve Stimulation application
Subjects will complete 100 mm visual analog scales at time zero, 15 and 30 minutes after taking Transcutaneous Electrical Nerve Stimulation application
次要结局
- Adverse events(30 minutes after)
研究者
Umut Gulacti
Principal Investigator
Adiyaman University Research Hospital