Comparison of Intravenous Ketorolac 10, 20, and 30mg for Treating Renal Colic Pain in the Emergency Department: A Randomized Controlled Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Pain assessed with visual analogue scale (VAS)
研究概览
简要总结
Hypothesis: Intravenous administration of Ketorolac 10 mg and 20 mg is as effective as 30 mg in treating renal colic pain in patients presenting to the emergency department
详细描述
Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that is widely used in the Emergency Department (ED). Because of the Ketorolac significant analgesic potency, it is usually used for moderate-to-severe pain. However, ketorolac has several side effects, of which gastrointestinal hemorrhage is most concerning. "Analgesic ceiling" is defined as the dose beyond which no additional analgesia can be achieved and on the other hand, more side effects might be encountered. Several studies suggested 10 mg as analgesic ceiling. Despite this, many recommendations are still advocating several folds higher doses (e.g. 30, 60 mg).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Severe flank and abdominal pain which pertains to renal colic according to emergency physician's gestalt
排除标准
- •Active Peptic Ulcer disease
- •Acute Gastrointestinal Hemorrhage
- •Known History of Renal or Hepatic insufficiency
- •History of allergies to NSAIDs
研究组 & 干预措施
Ketorolac 10mg
Subjects will be administered 10 mg of Ketorolac.
干预措施: Ketorolac (Drug)
Ketorolac 20mg
Subjects will be administered 20 mg of Ketorolac
干预措施: Ketorolac (Drug)
Ketorolac 30mg
As a part of standard care, subjects will be administered 30 mg of Ketorolac.
干预措施: Ketorolac (Drug)
结局指标
主要结局
Pain assessed with visual analogue scale (VAS)
时间窗: 30 Minutes
The visual analogue scale (VAS) will be used for the study. The VAS ranges from 0 (no pain) to 100 (very severe pain). The higher the pain scores the higher the pain severity.
次要结局
- Adverse Effects(60 Minutes)
- Pain assessed with visual analogue scale (VAS)(60 Minutes)
研究者
Hadi Mirfazaelian
Assistant Professor of Emergency Medicine
Tehran University of Medical Sciences