Comparison of Paracetamol and Dexketoprofen Trometamol on Headache Treatment After Electroconvulsive Treatment
试验速览
- 阶段
- 4 期
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Headache (Visual Analogue Scale 0-10)
研究概览
简要总结
Electroconvulsive treatment (ECT) is still actual for treatment of psychiatric symptoms. Headache is a very common symptom after this application. The investigators compare the effect of two different drugs for the treatment of headache after ECT.
详细描述
Electroconvulsive treatment (ECT) is used as an alternative application instead of drug therapy for psychiatric symptoms. ECT application is repeated 8-12 times according to the treatment of the patient. This treatment is done in 2 or 3 days intervals. The most adverse effects of ECT are headache, memory disorders, myalgia, nausea and vomiting, cardiovascular problems. The most common seen adverse effect is headache with approximately 60% incidence. The main drugs used for the treatment of headache related to ECT are NSAIs and paracetamol. The aim of the current study is to compare the effect of paracetamol and dexketoprofen trometamol on headache treatment after ECT.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who were admitted for ECT and gave informed written consent were included in the study.
排除标准
- •Exclusion criteria included patients who gave a history of allergy to acetaminophen, lacked capacity to give informed consent and developed complications such as delirium following ECT.
研究组 & 干预措施
Paracetamol
Parol group: intravenous infusion in 30 min Generic name: Parol Dosage form: intravenous Dosage: 1 gr Frequency: preop one dose only Duration: For one week
干预措施: Paracetamol (Drug)
Deksketoprofen trometamol
Sertofen group: intravenous infusion in 30 min Generic name: Sertofen Dosage form: intravenous Dosage: 50 mg Frequency: preop one dose only Duration: For one week
干预措施: Deksketoprofen trometamol (Drug)
Placebo
Placebo group: intravenous infusion in 30 min Generic name: Serum physiologic Dosage form: intravenous Dosage: 100 ml Frequency: preop one dose only Duration: For one week
干预措施: Placebo (Drug)
结局指标
主要结局
Headache (Visual Analogue Scale 0-10)
时间窗: Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)
Headache (VAS) change is being assessed in three different time frames after ECT
次要结局
- Additive analgesic-antiemetic consumption(Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention))
- Adverse effects (Nausea-Vomiting, bradycardia, hypotension)(Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention))
研究者
Onur Koyuncu
Assoc.Prof.MD
Mustafa Kemal University