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临床试验/CTRI/2026/03/106675
CTRI/2026/03/106675尚未招募不适用

Comparison of Critical Care Pain Observation Tool, Behavioral Pain Scale and Non-verbal Pain Scale for Pain Assessment in Mechanically Ventilated Post Surgical ICU Patients : A Prospective Observational Study

Sir Ganga Ram Hospital1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2026年3月28日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
106
试验地点
1
主要终点
Scores assessed by various behavioral pain tools (CPOT, BPS and NVPS) in response to a nociceptive procedure as determined by changes in physiological parameter (HR/MAP)

研究概览

简要总结

Pain assessment in critically ill patients, particularly those who are mechanically ventilated and unable to self-report, remains a significant challenge in intensive care practice. Effective pain management is central to improving patient comfort, reducing physiological stress, minimizing complications, and enhancing recovery. However, conventional self-reporting methods are not feasible in sedated or intubated patients, making reliance on observational and behavioral assessment tools essential. Several behavioral pain assessment scales have been developed and validated internationally, including the Critical-Care Pain Observation Tool (CPOT), Behavioral Pain Scale (BPS), and Non-Verbal Pain Scale (NVPS). Each of these tools measures pain through a combination of behavioral indicators and, in some cases, physiological parameters. Although they have been used in diverse ICU populations, their comparative performance in post-surgical mechanically ventilated patients within the Indian context has not been studied to the best of our knowledge. This prospective observational study will compare three behavioral pain assessment tools CPOT, BPS and NVPS in 106 mechanically ventilated post-surgical ICU patients. Pain assessments will be conducted at baseline and during standard nociceptive ICU procedures, including repositioning, endotracheal suctioning, and wound/drain management. Physiological indicators, specifically a greater or equal to 20 percent increase in heart rate or mean arterial pressure from baseline, will be used as a gold standard to evaluate the diagnostic accuracy of each tool. The primary objective is to compare the reliability, sensitivity, and specificity of CPOT, BPS and NVPS against physiological responses. The secondary objective is to analyze the internal consistency and component-level responsiveness of each scale to determine the most predictive behavioral indicators of pain. By addressing this gap, the study seeks to identify the most reliable and valid behavioral pain assessment tool for use in post-surgical ICU patients. The findings are expected to contribute to standardized pain assessment protocols, improve clinical decision-making and enhance the overall quality of critical care delivery in the Indian healthcare setting.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1.Post operative patients admitted to ICU and mechanically ventilated for 24 hrs.
  • 2.Adult patients both males and female 18 years of age or more.
  • 3.Hemodynamically stable at assessment time 4.Ramsay sedation scale 4 and 5.

排除标准

  • Patients with quadriplegia, use of neuromuscular blocking agents, presence of peripheral neuropathy 2.Morbidly obese (BMI greater than 40), pregnancy, left ventricular ejection fraction less than 25%.
  • 3.Patients with ongoing treatment for chronic pain, pre-existing psychiatric or neurological issues.
  • 4.Family members of eligible patients not willing to participate in the study.
  • 5.Ramsay sedation scale greater than
  • 6.Patients given breakthrough analgesia or sedation during the assessment.
  • 7.Patients receiving drugs likely to blunt or distort heart rate and blood pressure responses to nociceptive stimuli.

结局指标

主要结局

Scores assessed by various behavioral pain tools (CPOT, BPS and NVPS) in response to a nociceptive procedure as determined by changes in physiological parameter (HR/MAP)

时间窗: Baseline rest, during nociceptive procedures, and 20 minutes after completion of the procedure.

次要结局

  • Change in individual behavioral component scores within CPOT, BPS & NVPS in response to nociceptive procedures(Baseline rest, during nociceptive procedures & 20 minutes post-procedure.)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Raj kumar A

Sir Ganga Ram Hospital

研究点 (1)

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