A Prospective Randomized Double-Blind Trial Comparing 3 Doses of Intravenous Ketorolac for Pain Management in the Emergency Department"
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Pain Score at 30 Minutes
研究概览
简要总结
Hypothesis: Intravenous administration of Ketorolac in a dose of 10 mg is as effective in treating severe acute pain in patients presenting to the ED as 15 mg and 30 mg.
详细描述
Ketorolac tromethamine is a non-steroidal anti-inflammatory drug (NSAID) that is widely used in the Emergency Department (ED) for the treatment of moderate-to-severe pain. Ketorolac is available in both oral and parenteral forms and possess significant analgesic potency. However, ketorolac provides few advantages over other currently available analgesics and its use is limited by a virtue of having an "analgesic ceiling" with the dose being 10mg as well as having a range of severe side effects, of which gastrointestinal hemorrhage is most concerning.The concept of an analgesic ceiling is that doses beyond this value (10mg) do not provide additional analgesia and do contribute to side effects. In spite of this, the majority of research conducted on ketorolac in the ED and recommendations in Tintinalli's Emergency Medicine Textbook advocating for use of three-to-six fold higher dosages.
Hypothesis
Intravenous administration of Ketorolac in a dose of 10 mg is as effective in treating severe acute pain in patients presenting to the ED as 15 mg and 30 mg.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Severe flank and abdominal pain, severe musculoskeletal pain (traumatic and non-traumatic in origin), headache, dental pain.
排除标准
- •Age >65, Active Peptic Ulcer disease, Acute Gastrointestinal Hemorrhage, Known Hx of Renal or Hepatic insufficiency, Hx of allergies to NSAIDS.
研究组 & 干预措施
Group 1 - 10 mg of Ketorolac
Subjects will be administered 10 mg of Ketorolac for pain relief.
干预措施: 10 mg of Ketorolac (Drug)
Group 2 - 15mg
Subjects will be administered 15mg of Ketorolac.
干预措施: 15 mg of Ketorolac (Drug)
Group 3 - 30mg
Subject will receive 30mg of Ketorolac as a part of standard care.
干预措施: 30 mg of Ketorolac (Drug)
结局指标
主要结局
Pain Score at 30 Minutes
时间窗: 30 minutes
Pain score of each group at 30 minutes. The Numeric Rating Pain (NRS) scale was used for the study. The NRS ranges from 0 (no pain) to 10 (very severe pain). A score of 5 is moderate pain. The higher the pain score the higher the pain severity.
次要结局
- Adverse Effect of Nausea(120 minutes)
- Adverse Effect of Dizziness(120 minutes)
- Adverse Effect of Headache(120 minutes)
研究者
Antonios Likourezos
Research Manager
Maimonides Medical Center