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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Measurement of NFR and PDR | Other | Diagnostic intervention: excite NFR and PDR in comparison to behavior pain scale (BPS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measurement of NFR and PDR | Device | Feasibility testing of NFR and PDR in sedated, ventilated patients. Comparison of NFR and PDR with standard routine care of pain assessment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Test the feasibility of a objective pain evaluation tool; the nociception flexion reflex (NFR) | 10 seconds after nociceptive stimulation | |
| Test the feasibility of a objective pain evaluation tool; the pupillary dilatation reflex (PDR) | 10 seconds after nociceptive stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison NFR and the standard of care pain assessment (behavior pain scale) | Routine assessment of pain by attending nurse | In period of routine two hourly check up by nurse |
| Comparison PDR and the standard of care pain assessment (behavior pain scale) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Davina Wildemeersch, MD | University Hospital, Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital Antwerp | Edegem | Antwerpen | 2650 | Belgium |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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Routine assessment of pain by attending nurse |
| In period of routine two hourly check up by nurse |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |