Use of the critical-care pain observation tool and the bispectral index for the detection of pain in brain-injured patients undergoing mechanical ventilation: A STROBE-compliant observational study.

The assessment of pain in patients with brain injury is challenging due to impaired ability to communicate. We aimed to test the reliability and validity of the critical-care pain observation tool (CPOT) and the bispectral index (BIS) for pain detection in critically brain-injured patients.This prospective observational study was conducted in a neurosurgical intensive care unit in a University-Affiliated Hospital. Adult brain-injured patients undergoing mechanical ventilation were enrolled. Nociceptive (endotracheal suctioning) and non-nociceptive (gentle touching) procedures were performed in a random crossover fashion. Before and immediately after the procedure, CPOT was evaluated by 2 residents and 2 chief nurses, and BIS was documented. The ability to self-report pain was also assessed. The inter-observer reliability of CPOT was analyzed. The criterion and discriminant validities of the CPOT and the BIS were tested.During the study, we enrolled 400 brain-injured patients. The ability to self-report pain was maintained in 214 (54%) and 218 (55%) patients during suctioning and gentle touching, respectively. The intraclass correlation coefficients (95% confidence interval) for inter-observer reliability of CPOT ranged from 0.86 (0.83-0.89) to 0.93 (0.91-0.94). Using self-reported pain as the reference, the area under the receiver operating characteristic curve (95% confidence interval) was 0.84 (0.80-0.88) for CPOT and 0.76 (0.72-0.81) for BIS. When the 2 instruments were combined as either CPOT ≥2 or BIS ≥88 after the procedure, the sensitivity and specificity were 0.90 (0.85-0.93) and 0.59 (0.52-0.66), respectively; and when the 2 instruments were combined as both CPOT ≥2 and BIS ≥88, the sensitivity and specificity were 0.62 (0.55-0.68) and 0.89 (0.83-0.93). Both CPOT and BIS increased significantly after suctioning (all P < .001) but remained unchanged after gentle touching (P ranging from .06 to .14).Our criterion and discriminant validity results supported the use of CPOT and BIS to detect pain in critically brain-injured patients. Combining use of CPOT and BIS in different ways might provide comprehensive pain assessment for different purposes.