Comparison of the Analgesic Efficacy of Dexketoprofen Trometamol, Meperidine, and Paracetamol in Patients Presenting With Renal Colic
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 主要终点
- VAS score change at the 30th minute
研究概览
简要总结
This study aimed to compare the effectiveness of intravenous (IV) dexketoprofen trometamol, IV meperidine, and IV paracetamol as analgesics for renal colic in patients at the Emergency Department of Erciyes University Medical School. The double-blind, randomized trial included 90 patients aged 18-65 years. Patients were divided into three groups of 30, receiving 50 mg IV dexketoprofen trometamol, 50 mg IV meperidine, or 1000 mg IV paracetamol, administered in 250 mL of saline over 15 minutes. Pain intensity was measured at 15, 30, and 60 minutes post-administration using a 100-mm visual analog scale (VAS) and a 4-point verbal rating scale (VRS). Successful treatment was defined as a 50% or greater reduction in VAS score at 30 minutes. Patients with a VAS score of 40 mm or higher at the 30th minute were given fentanyl (1 mcg/kg, intravenously) as a rescue drug.
详细描述
Study design
This clinical trial was conducted at a single center, involving a prospective, randomized, double-blind study. The main objective was to compare the analgesic effectiveness of three different medications-IV dexketoprofen trometamol, IV meperidine, and IV paracetamol in patients who arrived at the emergency department with renal colic.
Selection of participants
Patients who had taken any analgesic medication in the six hours preceding their arrival, those who had a regular medication schedule, individuals under 18 years of age or over 65, hemodynamically unstable patients, patients with renal, hepatic, cardiac, or respiratory failure, those allergic to the drugs used in the study, pregnant or breastfeeding women, those with a history of renal transplantation, patients with only one kidney, individuals with serum creatinine levels exceeding 2 mg/dL, those with a history of gastrointestinal bleeding and peptic ulcer, and patients unable to fill out the pain scale due to vision problems were excluded from the study.
The patients were randomized and numbered using a computer. Ninety eligible patients diagnosed with renal colic and who agreed to participate in the study were included. Thirty patients were assigned to each of the three groups-dexketoprofen trometamol, meperidine and paracetamol.
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)
盲法说明
The physician who evaluated the patient ordered the analgesic X. Before the evaluation, the patients were informed about the pain scales to be used in the study, namely the visual analog scale (VAS) and verbal rating scale (VRS). The patients then made VAS and VRS markings on the evaluation forms without looking at the previous marking location. Neither the patients nor the physicians knew which study group they were in during the clinical practice phase, as the study was double-blind.
The study drugs were administered to patients suspected of having renal colic in random order with the same appearance. The nurse who prepared the solution was informed about the study, but the nurse who administered the drug did not know which group the patient was in.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to
- •Diagnosed with renal colic via anamnesis, physical examination, laboratory, and imaging tests.
- •Provided informed consent to participate in the research.
- •Both genders.
排除标准
- •Recent intake of any analgesic medication within six hours prior to arrival.
- •Regular medication schedule.
- •Age under 18 or over
- •Hemodynamically unstable patients.
- •Renal, hepatic, cardiac, or respiratory failure.
- •Allergies to study drugs.
- •Pregnant or breastfeeding women.
- •History of renal transplantation.
- •Presence of only one kidney.
- •Serum creatinine levels exceeding 2 mg/dL.
- •History of gastrointestinal bleeding or peptic ulcer.
- •Inability to complete the pain scale due to vision problems.
研究组 & 干预措施
Dexketoprofen trometamol
The study drugs were administered to patients suspected of having renal colic in random order: dexketoprofen trometamol IV 50 mg (ampoule containing Dexalgin 50 mg injectable solution) was prepared as a 250 mL solution in standard saline, with the same appearance. The drugs were given as a single dose over 15 minutes.
干预措施: Dexketoprofen Trometamol (Drug)
Dexketoprofen trometamol
The study drugs were administered to patients suspected of having renal colic in random order: dexketoprofen trometamol IV 50 mg (ampoule containing Dexalgin 50 mg injectable solution) was prepared as a 250 mL solution in standard saline, with the same appearance. The drugs were given as a single dose over 15 minutes.
干预措施: Fentanyl (Drug)
Meperidine
The study drugs were administered to patients suspected of having renal colic in random order: meperidine IV 50 mg (Aldolan 100 mg ampoule) was prepared as a 250 mL solution in standard saline, with the same appearance. The drugs were given as a single dose over 15 minutes.
干预措施: Meperidine Injectable Solution (Drug)
Meperidine
The study drugs were administered to patients suspected of having renal colic in random order: meperidine IV 50 mg (Aldolan 100 mg ampoule) was prepared as a 250 mL solution in standard saline, with the same appearance. The drugs were given as a single dose over 15 minutes.
干预措施: Fentanyl (Drug)
Paracetamol
The study drugs were administered to patients suspected of having renal colic in random order: paracetamol IV 1000 mg (Perfalgan 10 mg/mL infusion solution) was prepared as a 250 mL solution in standard saline, with the same appearance.The drugs were given as a single dose over 15 minutes.
干预措施: Paracetamol (Drug)
Paracetamol
The study drugs were administered to patients suspected of having renal colic in random order: paracetamol IV 1000 mg (Perfalgan 10 mg/mL infusion solution) was prepared as a 250 mL solution in standard saline, with the same appearance.The drugs were given as a single dose over 15 minutes.
干预措施: Fentanyl (Drug)
结局指标
主要结局
VAS score change at the 30th minute
时间窗: 0th minute and 30th minute
The time at which treatment began was recorded as 0th minutes and pain levels were measured using the VAS scale, which ranges from "0 mm (no pain)" to "100 mm (unbearable pain)". The pain levels were measured before treatment and at the 15th, 30th and 60th minutes after the treatment. Pain severity was evaluated using VRS and classified as "none"-"mild"-"moderate"-"severe". A treatment was considered successful if there was a 50% or greater reduction in the VAS score at the 30th minute.
次要结局
未报告次要终点
研究者
Ismail Tekin
Principal Investigator
Primary Health Care Corporation, Qatar