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临床试验/NCT04372264
NCT04372264Unknown4 期

Comparison of the Effect of Intravenous Paracetamol, Dexketoprofen and Ibuprofen on Visual Analogue Scale (VAS) in the Treatment of Acute Migraine Attack Headache in the Emergency Department: A Double-Blinded, Randomized, Controlled Trial

Pamukkale University1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2018年10月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
210
试验地点
1
主要终点
Decrement of the pain on VAS

研究概览

简要总结

  • Currently, paracetamol and nonsteroidal antiinflammatory drugs are widely used by emergency physicians in Turkey for the treatment of patients with Acute Migraine Attack Headache
  • The objective of the study is compare the efficacy of intravenous dexketoprofen,ibuprofen with paracetamol in the treatment of acute Migraine Attack Headache

详细描述

  • This is the randomized double blinded clinical trial to compare the efficacy of these three drugs in this clinical setting.
  • A randomized clinical trial was conducted in the Emergency Department (ED) of Pamukkale University Medical Faculty Hospital
  • Study personnel (emergency physicians and nurses) were trained before the study.
  • When intravenous drugs (Paracetamol, Dexketoprofen and ibuprofen) was being recommended, an eligibility checklist was completed by the attending physician.
  • If there were no exclusion criteria, written informed consent was obtained and baseline information, including initial Acute Migraine Attack Headache severity ratings with visual analog scale (VAS) were recorded.
  • The need for identification and enrollment of participants by staff with conflicting work pressures resulted in recruitment of a convenience sample of patients.
  • All patients eligible for the study were randomized to one of three groups:

First Group: 1000 mg of paracetamol ( perfalgan 10mg/ml solutionBristol- Myers Squibb_UK) intravenous (IV) was given 70 patients, Second Group: dexketoprofen 50 mg ( arveles ampoule -Ufsa- Istanbul) intravenous (IV) was given 70 patients, third group: 400 mg İbuprofen (İntrafen 400 mg vial-Gen-İstanbul) intravenous (IV) was given 70 patients, which determined to be applied as a group.

In addition, intravenous metoclopramide was added to the threatment of patients with acute migraine attack headache.

Drug packs prepared in 150 ml serum physiology were numbered by an independent nurse, who not involved in the study.

  • Drugs were prepared according to the computer-generated random number sequence to assign treatment allocations
  • The allocation list was kept by the emergency nurse. Patients received the paracetamol,dexketoprofen,ibuprofen medication schemes according to their random allocations.
  • After enrollment and recording of baseline information, the next numbered study drug pack was obtained, and administered intravenously.
  • Randomization was achieved by using computer software to generate random numbers. During the intervention, participants were monitored by an oxygen saturation (SpO2) monitor, an automatic sphygmomanometer (blood pressure), and a rhythm monitor (heart rate and rhythms)
  • One researcher blinded to patient allocation observed the whole procedure and recorded the acute migraine attack headache scores.
  • Patients in three groups received three types of medication in a similar manner, thus ensuring double blind.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
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

入选标准

  • Patients were eligible for inclusion if they were aged 18 years or older, 65 years or younger
  • Isolated Migraine Attack Headache
  • Patients who agree to work and receive the approval
  • VAS (visual analog scale) score>5.

排除标准

  • Patients with severe liver, kidney,pulmonary and cardiac heartfailure
  • To be Pregnancy and breast-feeding
  • Have received analgesics in the last 6hours
  • Patients of childbearing age who are not using a birth control method.
  • Patients with neurological deficits
  • Patients with cardiac chest pain
  • Patients with chronic pain
  • Patients with pre-existing ibuprofen, dexketoprofen and paracetamol-induced gastrointestinal bleeding and perforation
  • Patients with reflected pain
  • Patients with neoplastic pain
  • Patients with an allergy trait (ibuprofen, paracetamol and dexketoprofen)
  • Illiterates and patients with vision problems

研究组 & 干预措施

Paracetamol

Experimental

1000 mg of paracetamol ( perfalgan 10mg/ml solutionBristol- Myers Squibb_UK) intravenous (IV) was given 70 patients,

干预措施: Paracetamol (Drug)

Dexketoprofen

Experimental

Second Group: dexketoprofen 50 mg ( arveles ampoule -Ufsa- Istanbul) intravenous (IV) was given 70 patients,

干预措施: Dexketoprofen (Drug)

Ibuprofen

Experimental

third group: 400 mg Ibuprofen (İntrafen 400 mg vial-Gen-İstanbul) intravenous (IV) was given 70 patients, which determined to be applied as a group.

干预措施: Ibuprofen (Drug)

结局指标

主要结局

Decrement of the pain on VAS

时间窗: Baseline and 60 minutes

Comparison of the reduction of Migraine Attack Headache VAS (visual analog scale) score between the three groups. - (First group Paracetamol, Second Dexketoprofen and Third Ibuprofen )

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ibrahim Turkcuer

Professor, MD

Pamukkale University

研究点 (1)

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