Comparison of Analgesic Efficacy of Transcutaneous Electrical Nerve Stimulation and Dexketoprofen Trometamol in Patients Presenting to the Emergency Department With Renal Colic: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Change of the intensity of pain
研究概览
简要总结
The aim of this study was to compare the analgesic efficacy of transcutaneous electrical nerve stimulation (TENS) and dexketoprofen trometamol in patients presenting to the emergency department due to renal colic.
详细描述
Renal colic is a common presenting complaint to the emergency department and is an intensely painful condition. Parenteral opioids, non-steroidal anti-inflammatory drugs (NSAIDs) and paracetamol are commonly used to relieve the pain of renal colic. Dexketoprofen trometamol is a non-steroidal anti-inflammatory drug that is frequently used in the management of acute pain. Common and known side effects of nonsteroidal anti-inflammatory drugs include gastrointestinal system problems and allergic reactions. Transcutaneous electrical nerve stimulation is a non-invasive, non-pharmacological and low-risk treatment method. This study aimed to compare the analgesic efficacy of Transcutaneous electrical nerve stimulation and dexketoprofen trometamol in patients presenting to the emergency department with renal colic.
Study Design and Setting: A prospective, randomized, double-blind, single-center, clinical trial will be conducted in emergency department of a tertiary care university hospital.
Statistical Analysis
Categorical variables will be presented as numbers and percentages. The Kolmogorov-Smirnov test will be used to evaluate the normality of the distribution of continuous variables. Continuous variables with a non-normal distribution will be expressed as the median and interquartile range (IQR), and those with a normal distribution will be expressed as the mean and standard deviation (SD). The Mann-Whitney U test will be used to analyse non-normally distributed variables to evaluate the differences in visual analog scale scores between the two groups; the Student's t-test will be used for normally distributed variables.
The sample size was calculated using the G*Power 3.1.9.2 programme. According to the data obtained from the study of renal colic therapy with TENS, a difference of 18.4 mm in visual analogue scale score between the two groups with a standard deviation of 6 mm was assumed. It was calculated that 64 patients were required for each group with a two-sided critical value of α = 0.05, 95% power and an effect size of 0.5.
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
- •- Aged 18 years or over with a definite diagnosis of renal colic
排除标准
- •Patients who refuse to participate in the study
- •Pregnant women
- •Breastfeeding women
- •Haemodynamically unstable
- •Evidence of peritoneal inflammation
- •Patients who were taking analgesics at the time of initial presentation
- •Unconsciousness or inability to communicate
- •Contraindications to applying TENS or using the drug in the study.
研究组 & 干预措施
Real Transcutaneous electrical nerve stimulation (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)
dexketoprofen trometamol
50 mg dexketoprofen trometamol
干预措施: Dexketoprofen Trometamol (Drug)
结局指标
主要结局
Change of the intensity of pain
时间窗: 15 minutes and 30 minutes after the administration of the study interventions
Pain intense will be measured by 100 mm visual analog scale (Zero; no pain and 100 mm; the worst pain) after 15th and 30th minutes later the administration of the study interventions
次要结局
- Adverse events(30 minutes after)
- need to rescue medication(30 minutes after)
研究者
Umut Gulacti
Professor
Adiyaman University Research Hospital