Διερεύνηση αποτελεσματικότητας της συστηματικής αξιολόγησης του πόνου στους βαρέως πάσχοντες
Date Issued
2015
Author(s)
Advisor
Abstract
Introduction: Pain is a multifactorial problem witch still exists, underestimated and not effectively treated in the ICU. Pain has broad impact on organic and mental health of critically ill patients and can further aggravate the clinical severity and determine their clinical outcome. Effective management of pain depends largely on the systematic and comprehensive assessment in order to make decisions relating to the optimal use of analgesia and management of the necessary medication. However, the inability of the critically ill patients to express their pain, because of sedation or cognitive impairment, paralysis or mechanical ventilation, makes the assessment of pain in the ICU a big challenge.
Purpose: The purpose of this clinical trial is to investigate the effectiveness of a structured systematic assessment of pain in critically ill patients, hospitalized in the ICU, for the level and frequency of pain episodes, the rational use of analgesics and sedatives and clinical and biological parameters.
Sample and method: N = 117 severely ill patients were included from a general ICU who were randomized into two groups, intervention group (N = 56) and control group (N = 61). The intervention involved systematic assessment of pain twice daily (morning and evening) for 10 consecutive days, with the pain assessment tools NRS, CPOT and BPS, in both groups. Moreover, in the intervention group the results of pain assessments were communicated to nurses and their actions were recorded. All evaluations were conducted by research associates. At the same time, clinical and biochemical indicators were recorded daily. The 1st, 3rd and 5th study days blood samples were optained from the patients in both groups for purposes of quantification of the levels of serum stress-related neuropeptide Y (NPY). The NPY levels were quantified by the immunoenzymatic ELISA method. The effect of intervention in pain level was studied using the multifactorial analysis LINEAR MIXED MODELS (LMM) by adjusting for potential confounding factors.
Results: The demographic and clinical characteristics did not differ between the two groups at baseline. The mixed linear models showed a statistically significant effect of the intervention on the level of pain as measured by the BPS scale (p = 0.01) but not with the CPOT scale (p = 0,112 before turning, p = 0,145 during turning). Furthermore, the statistical Cohran test, for the study of repeated rates, indicated that the incidence of pain episodes in the intervention group was not significantly changed as measured with the CPOT (Q = 3.529 p = 0.619) and the BPS (Cohran's Q = 13.656 p = 0.135). In contrast, in the control group it was observed a significant increase of pain episodes in both scales CPOT (Q = 19.512 p = 0.002), BPS (Cohran'sQ = 32.091 p <0.001). The average total of Morphine Equivalent dose in the intervention group was higher than in the control group (p = 0.045) as well as the average total dose of Propofol (p = 0,027). The NPY levels showed a positive correlation with pain intensity scale BPS (b = 0.045 p = 0.013) and CPOT during turning (b = 0.078 p = 0.015), after adjustment was made for sex and age of patients.
Conclusions: This study is the first to apply randomized clinical trial methodology to investigate the efficacy of a systematic evaluation of pain in clinical outcome of critically ill. The results provide strong evidence that the systematic evaluation of pain by the use of valid and reliable tools can contribute positively to reducing the level of pain and pain episodes and influence the pharmacological management of pain and sedation of patients in the ICU. Moreover, the emergence of NPY positive correlation with level of pain is a promising field for further research and possible future inclusion of NPY as an objective biochemical pain assessment indicator.
Purpose: The purpose of this clinical trial is to investigate the effectiveness of a structured systematic assessment of pain in critically ill patients, hospitalized in the ICU, for the level and frequency of pain episodes, the rational use of analgesics and sedatives and clinical and biological parameters.
Sample and method: N = 117 severely ill patients were included from a general ICU who were randomized into two groups, intervention group (N = 56) and control group (N = 61). The intervention involved systematic assessment of pain twice daily (morning and evening) for 10 consecutive days, with the pain assessment tools NRS, CPOT and BPS, in both groups. Moreover, in the intervention group the results of pain assessments were communicated to nurses and their actions were recorded. All evaluations were conducted by research associates. At the same time, clinical and biochemical indicators were recorded daily. The 1st, 3rd and 5th study days blood samples were optained from the patients in both groups for purposes of quantification of the levels of serum stress-related neuropeptide Y (NPY). The NPY levels were quantified by the immunoenzymatic ELISA method. The effect of intervention in pain level was studied using the multifactorial analysis LINEAR MIXED MODELS (LMM) by adjusting for potential confounding factors.
Results: The demographic and clinical characteristics did not differ between the two groups at baseline. The mixed linear models showed a statistically significant effect of the intervention on the level of pain as measured by the BPS scale (p = 0.01) but not with the CPOT scale (p = 0,112 before turning, p = 0,145 during turning). Furthermore, the statistical Cohran test, for the study of repeated rates, indicated that the incidence of pain episodes in the intervention group was not significantly changed as measured with the CPOT (Q = 3.529 p = 0.619) and the BPS (Cohran's Q = 13.656 p = 0.135). In contrast, in the control group it was observed a significant increase of pain episodes in both scales CPOT (Q = 19.512 p = 0.002), BPS (Cohran'sQ = 32.091 p <0.001). The average total of Morphine Equivalent dose in the intervention group was higher than in the control group (p = 0.045) as well as the average total dose of Propofol (p = 0,027). The NPY levels showed a positive correlation with pain intensity scale BPS (b = 0.045 p = 0.013) and CPOT during turning (b = 0.078 p = 0.015), after adjustment was made for sex and age of patients.
Conclusions: This study is the first to apply randomized clinical trial methodology to investigate the efficacy of a systematic evaluation of pain in clinical outcome of critically ill. The results provide strong evidence that the systematic evaluation of pain by the use of valid and reliable tools can contribute positively to reducing the level of pain and pain episodes and influence the pharmacological management of pain and sedation of patients in the ICU. Moreover, the emergence of NPY positive correlation with level of pain is a promising field for further research and possible future inclusion of NPY as an objective biochemical pain assessment indicator.
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