Study of Comparing Dexketoprofen to Placebo in Migraine Attack
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale Change
研究概览
简要总结
H0 hypothesis: IV dexketoprofen is equivalent to placebo in ceasing migraine attack in emergency department.
H1 hypothesis: IV dexketoprofen is not equivalent (superior) to placebo in ceasing migraine attack in emergency department.
详细描述
Migraine attack is one of the most leading causes presentations to emergency department. Patients with migraine attack seek urgent care to cease their pain. There are so many interventions defined in the medical literature that can be used in migraine attacks. However, as a IV drug, dexketoprofen; little known whether IV dexketoprofen is superior to placebo or not. In the present study we aimed to determine the effects of IV dexketoprofen in migraine attack in emergency department.
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)
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
- •patients presented with headache who diagnosed as migraine attack according to the international headache society
排除标准
- •denied to give inform concent, illiterate patients, chronic renal failure, taking NSAIDs during the last six hours, pregnancy
研究组 & 干预措施
Dexketoprofen
50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.
干预措施: Dexketoprofen (Drug)
normal slaline
50 ml normal saline
干预措施: Normal Saline (Other)
结局指标
主要结局
Visual Analogue Scale Change
时间窗: 45 minutes
Change from baseline in Visual Analogue Scale, 100 mm, at 45th minutes. Visual Analogue Scale is measurement tool scoring tool between 0 (no pain) and 100 mm (worst pain). Minimum clinically significant change in pain score is 13 or 16 mm.
次要结局
- Adverse Effects(45th minutes)
研究者
Cenker Eken
Associated Proffesor
Akdeniz University