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临床试验/NCT03432546
NCT03432546已完成不适用

Acute and Persistent Pain in Intensive Care Patients

Tampere University Hospital2 个研究点 分布在 1 个国家目标入组 707 人开始时间: 2018年4月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
707
试验地点
2
主要终点
Incidence of persistent neuropathic pain using Pain Detect

研究概览

简要总结

Approximately 20,000 patients are treated in intensive care units (ICU) in Finland annually. During ICU stay many diagnostic and other procedures as well as immobilization and underlying diseases may cause pain. Therefore the incidence of pain in ICU patients can be high. Acute pain may cause several detrimental effects including respiratory distress, tissue hypoxia, immunosuppression and anxiety. After discharge many survivors of critical care have lower health-related quality of life, symptoms of post-traumatic stress disorder or persistent pain.

Only few studies with a focus on acute or persistent pain in ICU patients have been made, hence the incidence and risk factors for ICU-related pain is not very well known. Some of the identified risk factors for persisting pain may be increased age, sepsis or inadequate pain management during ICU stay. Opioids are most often used for analgesics in intensive care. Because they may have several adverse effects the use must be based on validated pain scales. Many factors such as sedation, relaxation or delirium of the patient complicates the management of the pain.

This prospective observational study aims to determine the incidence and risk factors for acute and persistent pain in ICU patients as well as and the use of analgesics during intensive care.

详细描述

This prospective observational study aims to determine the incidence and risk factors for acute and persistent pain in ICU patients as well as and the use of analgesics during intensive care.

The recruitement process is finished, but the follow-up is on-going. Patients are followed-up by subsequent questionnaires until 5 years after admission to the ICU.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • not meeting the exclusion criteria

排除标准

  • pregnant patients
  • age under 18 years
  • suffering from significant brain injury
  • elective neurosurgical patients
  • probable organ donors
  • suffering from significant cognitive impairment
  • presumed death under 48h

结局指标

主要结局

Incidence of persistent neuropathic pain using Pain Detect

时间窗: At intensive care follow up clinic at three months after discharge and thereafter the change in pain annually for 5 years

Moderate or severe pain.

Incidence of anxiety affecting persistent pain

时间窗: At intensive care follow up clinic at three months after discharge and thereafter the change in anxiety annually for 5 years

State Trait anxiety Index T (STAI-T)

Incidence of acute pain

时间窗: Through study completion, an average of 3 days

Moderate or severe pain (numerical rating scale (NRS) value above 3 / critical pain observatory tool (CPOT) value ≥3) during intensive care

次要结局

  • Delirium(Through study completion, an average of 3 days)
  • Analgesic use(Through study completion, an average of 3 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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