An interventional study of Measurement of NFR and PDR in Critical Illness, sponsored by University Hospital, Antwerp. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-15.
Sponsored by University Hospital, Antwerp · Not applicable, Interventional, and Diagnostic
The aim of the study was to describe the feasibility of the nociception flexion reflex and the pupillary dilatation reflex as objective pain assessment tools in the Intensive Care Unit (ICU). Furthermore to describe the relationship between the responses and the standard of care pain evaluation in the critically ill sedated patients.
Patients were under propofol / remifentanil or propofol / sufentanil sedation protocol during measurements in a stair-case increasing intensity model of standardized stimulations. (Stimulation intensity are similar to the stimulations of neuromuscular blocking agents monitoring.)
Pupillary dilatation reflex: tetanic stimulations at the nervus medianus were performed starting form 10 milliamperes (mA) up to 60mA. Pupillary diameter was measured before, during and after stimulation.
Nociception flexion reflex: tetanic stimulations at the nervus suralis were performed starting form 0.5mA in increasing steps via an automated RIII (NFR) threshold tracking model.
Exclusion Criteria:
Diagnostic intervention: excite NFR and PDR in comparison to behavior pain scale (BPS)
Device: Measurement of NFR and PDR
Feasibility testing of NFR and PDR in sedated, ventilated patients. Comparison of NFR and PDR with standard routine care of pain assessment
Test the feasibility of a objective pain evaluation tool; the nociception flexion reflex (NFR)
Time frame: 10 seconds after nociceptive stimulation
Test the feasibility of a objective pain evaluation tool; the pupillary dilatation reflex (PDR)
Time frame: 10 seconds after nociceptive stimulation
Comparison NFR and the standard of care pain assessment (behavior pain scale)
Routine assessment of pain by attending nurse
Time frame: In period of routine two hourly check up by nurse
Comparison PDR and the standard of care pain assessment (behavior pain scale)
Routine assessment of pain by attending nurse
Time frame: In period of routine two hourly check up by nurse
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University Hospital, Antwerp