The Comparison of the Effectiveness of Intravenous Dexketoprofen and Paracetamol in the Treatment of Headache Caused by Acute Migraine Attack in Emergency Service
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Reduction in visual analogue scale and Numeric Rating Scale
研究概览
简要总结
Patients with acute migraine attack make up the majority of patients consulting the emergency services due to headache. The aim of treatment in the emergency service is to achieve a minimum level of undesirable side effects and to quickly relieve the pain which will not repeat after discharge from the emergency service. Ideal drug treatment contraindication should be at a minimum level and not trigger migraine. Paracetamol and Nonsteroidal anti-inflammatory drugs are often used in the treatment of migraine headache.
Although narcotic analgesics provide effective and rapid analgesia, they have such side effects as hypotension, nausea and vomiting, drowsiness. In recent years, with the production of parenteral forms of non-steroidal anti-inflammatory painkillers, the analgesic efficacy of these drugs has been one of the topics of interest to researchers. Especially intravenous form of paracetamol is new yet compared to other Nonsteroidal anti-inflammatory drugs, and it is a drug with a wide safety margin and less incidence of side effects. The effectiveness of the Intravenous form of paracetamol and whether it can be an alternative to other analgesics is one of the major research topics today, and more study is needed on this subject.
Both drugs are often used in emergency services to treat headache caused by acute migraine attack. Our aim is to compare the effectiveness of intravenous dexketoprofen with paracetamol in the treatment of the headache caused by acute migraine attack.
详细描述
Materials and Methods of Research:
Among the patients consulting the emergency service with a complaint of headache, those who meet the criteria of 'International Classification of Headache Disorders criteria for migraine without aura' and agreed to participate in the study will form the study group.
The patients forming the study group will be included in the study after they are evaluated according to the criteria of inclusion or exclusion. Our research is an equivalence study. Provided that the difference between the groups is 50 %, α: 99 %, and 1-β: 80 %, it has been determined that each group should include at least 94 subjects, and the number of voluntary subjects has been determined as 200, each group containing 100 subjects.
First of all, in the measurement of the frequency of headaches, the standard 11-point Numeric Rating Scale (NRS), whose reliability is proven, and 100-mm visual analog scale (VAS) will be used. For NRS, patients will be asked to score their pain on a scale ranging from 0 to 10, scoring 0 (zero) in the absence of pain, and 10 in the case of most severe pain; whereas, for VAS, they will be asked to score their pain on a scale ranging from 0 to 100, scoring 0 in the absence of pain, and 100 in the case of most severe pain. Verbal rating scale (VRS) with 4 standard points will be used as another measurement tool. In this measurement, patients will be asked to express their pain as severe, moderate, mild and no pain.
The patients will be divided to two groups.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a. Patients who are 18 years of age and older, and who agreed to participate in the study will be included in the study.
排除标准
- •Patients having received analgesic in the last six hours,
- •pregnant women,
- •women of childbearing potential and not using birth control,
- •those who do not agree to participate in the study,
- •those under age of 18, those who have signs of peritoneal irritation,
- •those who are allergic to drugs used in the study,
- •hemodynamically unstable patients,
- •patients with renal transplant,
- •those who suffer from liver, kidney, cardiac and pulmonary insufficiency and others with systemic diseases,
- •patients with vision problems and those who are illiterate will be excluded from the study.
研究组 & 干预措施
Paracetamol
Paracetamol which will be given after randomization will be diluted in serum physiologic and will be given as intravenous rapid infusion.
干预措施: Paracetamol (Drug)
Dexketoprofen
Dexketoprofen which will be given after randomization will be diluted in serum physiologic and will be given as intravenous rapid infusion.
干预措施: Dexketoprofen (Drug)
结局指标
主要结局
Reduction in visual analogue scale and Numeric Rating Scale
时间窗: 15 minutes interval
The pain of the study subjects was measured after 15th and 30th minutes later after the study drug administered.
次要结局
- Adverse events(30th minutes after)
研究者
Mustafa Serinken
Pamukkale University denizli / TURKEY
Pamukkale University