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临床试验/CTRI/2020/08/027309
CTRI/2020/08/027309尚未招募不适用

Accuracy of Critical Care Pain Observation Tool and Behavioral Pain Scale to Assess Pain in Mechanically Ventilated Critically Ill Patients: A Prospective, Observational Study

Amala Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年8月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
To compare CPOT and BPS in unconscious critically ill mechanically ventilated patients and to determine the most relevant parameters for evaluation of pain in those patients.

研究概览

简要总结

Pain management in critically ill patients is highly underestimated, even though it seems to be the patient’s worst memory in ICU, even after 5 years of discharge. In unconscious patients, 2 scales have been proposed to assess pain in ICU patients: Critical Care Pain Observation Tool (CPOT) and Behavioural Pain Scale(BPS). However the potential superiority of each of them for assessment of pain in mechanically ventilated patients is not well established. Hence, we designed this study to evaluate the accuracy between CPOT and BPS scales in assessing pain in mechanically ventilated critically ill patients.

After meeting the inclusion and exclusion criteria, a total of 50 patients will be recruited for the study. The patients will receive sedation as per institutional protocol. Sedation will be assessed using Ramsay Scale. After recruitment all patients will be assessed for pain using CPOT, BPS and NVPS (non verbal pain scale), along with physiological indicators of pain ie. heart rate and arterial blood pressure at 2 time points, one in the morning and one at night. At each of these time points, pain will be assessed at rest as well as at 2 painful nursing procedures ie. tracheal suctioning and body positioning.

研究设计

研究类型
Observational

入排标准

年龄范围
16.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • who were endotracheally intubated and required mechanical ventilation in ICU.

排除标准

  • Patients were excluded if
  • if they were quadriplegic
  • receiving neuromuscular blocking medications
  • had a peripheral neuropathy,
  • pregnancy, and morbid obesity
  • received medical treatment for chronic pain
  • had pre-existing psychiatric or neurological problems
  • had a dependence on alcohol or drugs
  • had complications after surgery (e.g., haemorrhage and delirium).

结局指标

主要结局

To compare CPOT and BPS in unconscious critically ill mechanically ventilated patients and to determine the most relevant parameters for evaluation of pain in those patients.

时间窗: At the completion of the study ie.at 6 months

次要结局

  • To compare both pain scales with NVPS (Non Verbal Pain Scale) in these patients and to identify the best combination of scales for evaluating pain.(At the completion of the study ie.at 6 months)
  • To compare the accuracy of CPOT, BPS and NVPS with physiological indicators such as blood pressure and heart rate for pain assessment in critically ill patient.(At the completion of the study ie.at 6 months)

研究者

申办方类型
Private medical college

研究点 (1)

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