A Randomized-controlled Study; Comparison of the Effectiveness of Intravenous Ibuprofen and Intravenous Dexketoprofen in the Treatment of Migraine-related Headache in the Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Resolving of Headache at 60 minute
研究概览
简要总结
In this study, the investigators planned to compare the effectiveness of an intravenous ibuprofen against an intravenous dexketoprofen among patients (18-65 years) who were admitted to the emergency department (ED) with acute migraine-related headaches and diagnosed migraine without aura.
In this study, patients who presented with migraine-related headache to emergency departments will be included in this study. Two different therapy option are created; first, 400mg intravenous ibuprofen with 10mg intravenous metoclopramide Hcl , second, 50 mg intravenous dexketoprofen with 10mg intravenous metoclopramide Hcl.
Patients's headache scores will be measured with visual analog score (VAS) at the pretreatment and post-treatment periods (0. minutes, 30. minutes, and 60. minutes.) 60 minutes after treatment, as a rescue therapy, 100mg tramadol will be given to patients whose headache score does not decrease by more than 50% from pretreatment-VAS score.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All the patients aged 18-65 years who had been admitted to the ED for headaches and diagnosed acute migraine-related headache according to the International Classification of Headache Disorders-2018 edition
- •Patients whose pre-treatment VAS scores are more than 40 point.
- •Patients who give written and verbal consent to include study.
排除标准
- •Patients had taken any analgesic drugs or drugs for migraine prophylaxis in the last 6 hours
- •Patients had a history of allergy to any of the drugs used in this study
- •Patients used any anticoagulant-agents,
- •Patients had bleeding diathesis
- •patients were pregnant,
- •patients were breastfeeding mothers
- •Patients who had chronic heart disease, chronic liver disease, and chronic kidney disease
- •Patients had peptic ulcer
- •Patients had a history of acute akathisia or acute dystonia to metoclopramide hcl
研究组 & 干预措施
ibuprofen
400mg intravenous ibuprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.
干预措施: Ibuprofen 400 mg (Drug)
dexketoprofen
50 mg intravenous dexketoprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.
干预措施: Dexketoprofen (Drug)
结局指标
主要结局
Resolving of Headache at 60 minute
时间窗: 60 minutes after treatment - Change from Baseline Visual Analog Scale at 60th minutes
Patients's headache scores will be measured by using Visual Analog Scale (VAS). This scale ranged from 0mm (no pain) to 100mm (worst pain). Measurements will be performed at pre-treatment period and 60th minute after treatments.
次要结局
- Side and adverse effects(From start of performing drug to in the first 24 hours after drug administration)
- Resolving of Headache at 30 minute(30 minutes after treatment-Change from Baseline Visual Analog Scale at 30th minutes)
- Needing of rescue treatment(60 minutes after treatment)
研究者
Şeref Kerem Çorbacıoğlu
Associated Professor
Kecioren Education and Training Hospital