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临床试验/NCT02236442
NCT02236442已完成不适用

Therapeutic Management of Acute Cephalalgia Before and After Use of a Therapeutic Protocol in Emergency Department

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2014年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
Clinical improvement

研究概览

简要总结

The purpose of this study is to determine if the use of a therapeutic and global protocol to relieve cephalalgia is helpful in the emergency department of Grenoble University Hospital.

详细描述

Cephalalgia is a very common symptom that justifies daily appointment in emergency department.

Analgesic support, and especially use of oxygen and care of associated symptoms as nausea, photophobia or phonophobia, is very dependent on the physician.

The aim of this study is to evaluate the impact of a global analgesic protocol of cephalalgia in emergency department.

The investigators included 200 patients aged of 18 up to 55 years old coming in emergency department for headache. Pain (Visual analogic scale), nausea, photo or phonophobia are recorded each 15 minutes by the patient by using a self-assessment questionnaire. The final diagnosis is recorded by the physician in charge of patient, using International Headache Society criteria.

First 100 patients(group 1) receive usual care.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Complain about cephalalgia
  • •Age 28 to 55 years.

排除标准

  • •Fever > 38,0 °C
  • •History of breath disease, long term use of oxygen therapy, chronic obstructive pulmonary disease, dyspnea
  • •History of cranial traumatism, heart attack, cerebrovascular accident <3 month
  • •Inability to read or understand french.
  • •Pregnancy

研究组 & 干预措施

Usual care

No Intervention

First arm : Passive recording head pain, linked symptoms, treatment used and diagnosis.

After protocol recommendation care

Experimental

Recording head pain, linked symptoms, treatment used and diagnosis after intervention that is recommendation to use global headache treatment protocol

干预措施: Recommendation to use global headache treatment protocol (Other)

结局指标

主要结局

Clinical improvement

时间窗: 1 hour after treatment

"Clinical improvement" is defined as "Reduction of at least 50% of quantified pain 1 hour after treatment Comparison of proportion of "clinical improvement" between the 2 groups.

次要结局

  • Length of the hospitalization in emergency department(Duration of hospitalisation in emergency department stay, an expected average of 6 hours)
  • Pain score on the visual analog scale(1 hour after treatment)
  • Time required before medication(Time of administration of first medication, an expected average of 30 minutes)
  • Pain depending on the kind of cephalalgia(1 hour after treatment)
  • Impact of different kind of analgesic therapeutic(1 hour after treatment)
  • Hospitalisation requirement(Exit of emergency department, an expected average of 6 hours)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

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