A Single Center, Prospective Randomized Double-blind Trial: Efficacy of Nefopam and Morphine in Balanced Analgesia for Acute Ureteric Colic
试验速览
- 阶段
- 4 期
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Amount of pain reduction by visual analog pain scale
研究概览
简要总结
This study is to see whether the combination regimen of ketorolac and nefopam is superior to that of ketorolac and morphine in controlling ureter stone-related acute flank pain.
详细描述
The balanced analgesia regimen using both ketorolac and morphine is the most effective choice in controlling urolithiasis related acute pain. Previous animal and human studies reported that combination regimen of ketoprofen and nefopam showed synergistic effect in pain control. We hypothesized that using nefopam instead of morphine for ketorolac based combination analgesia will produce similar pain reduction without causing opioid-related side effect.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute flank with visual analog pain scale score equal or more than 5
- •and most possible diagnosis after initial clinical exam is acute renal colic
排除标准
- •Pregnant or lactating women
- •Patients whose use of any of the study drugs is contraindicated
- •Patients with documented renal or hepatic failure or those with clinical findings suggesting the diagnoses
- •Recent episode of acute myocardial infarction or patients with significant heart failure
- •Patients with documented gastric/duodenal ulcer or those with clinical findings suggesting the diagnoses
- •Patients with bleeding tendency
- •Patients who have history of any seizure
- •Patients with documented organic brain injury
- •Patients taking warfarin
- •Patients whose primary diagnosis is not renal colic
研究组 & 干预措施
Group 1
Sequential intravenous administration of ketorolac and nefopam
干预措施: Ketorolac and nefopam balanced analgesia (Drug)
Group 2
Sequential intravenous administration of ketorolac and morphine
干预措施: Balanced analgesia using ketorolac and morphine (Drug)
Group 3
Intravenous administration of ketorolac
干预措施: Pain control with single analgesics (ketorolac) (Drug)
结局指标
主要结局
Amount of pain reduction by visual analog pain scale
时间窗: At 30 and 60 minutes after primary study drug administration
次要结局
- Additional analgesia requested by enrolled patients(At 30 and 60 minutes after primary study drug administration)