NCT05019898UnknownNot Applicable
Comparison Between Pupillometry and the Numerical Rating Scale for the Assessment of Pain in Communicating Adult Patients Presenting to the Emergency Room.
Cliniques universitaires Saint-Luc- Université Catholique de Louvain2 sites in 1 country320 target enrollmentStarted: August 4, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 320
- Locations
- 2
- Primary Endpoint
- The primary outcome will be the correlation between the pupillometry values and those obtained by the numerical pain rating scale with a correlation coefficient of 0.78.
Study Overview
Brief Summary
Given the difficulties encountered with subjective pain assessment tools, one of the ideas for reducing the occurrence of insufficient analgesia administration in the emergency department is to find a tool capable of measuring pain without requiring the patient's participation, and which could be integrated into the systematic measurement of the 4 other vitals. An interesting idea is the measurement of pupillary diameter and its reflex variations by a portable pupillometer. Indeed, the diameter of the pupil (DP) reflects the constant interactions between the sympathetic and parasympathetic systems at the level of the iris muscles. Pupillometry measures the change in pupillary diameter and allows the performance of three dynamic tests useful in the assessment of pain.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients presenting to the emergency room, aged 18 years or over, able to communicate, with hemodynamic and respiratory stability, are eligible.
Exclusion Criteria
- •- Refusal to participate in the study; refusal to sign informed consent.
- •Consent impossible to obtain (cognitive disorders, language barrier...).
- •Patient taking immediate-release opioid medication (last dose within the last 12 hours).
- •Patient taking prolonged-release opioid medication (last dose within the last 24 hours).
- •Basic treatment with a dopaminergic D2 antagonist (antipsychotic drugs).
- •Basic treatment with dopamine antagonist antiemetic medication (metoclopramide (T1/2 5-6h), domperidone (T1/2 7-9h), alizapride (T1/2 3h)) within the last 12 hours.
- •Patient taking clonidine (last dose within the last 24 hours).
- •Use of topical ocular drugs modifying pupillary parameters in the last 24 hours.
- •Bilateral eye surgery modifying the possibilities of variation in pupillary diameter bilaterally.
- •Parkinson's or Alzheimer's disease at a dysautonomic stage.
- •Admission to the emergency room for acute ocular pathology.
- •History of diabetes at a dysautonomic stage.
- •History of alcoholism at a dysautonomic stage.
- •History of glaucoma.
- •Pregnant patient with preeclampsia.
Outcomes
Primary Outcomes
The primary outcome will be the correlation between the pupillometry values and those obtained by the numerical pain rating scale with a correlation coefficient of 0.78.
Time Frame: 1 minute
Secondary Outcomes
- The correlation of the pupillometric parameters with the level of anxiety quantified by a numeric scale next to 1 (not anxious) to 10 (maximum level of anxiety).(1 minute)
- The endpoint will be the evaluation of the performance of pupillometry to predict the occurrence of Numerical Rating Scale (NRS) ≥ 4 using the ROC curve (AUC).(1 minute)
- The correlation between the initial measurement of PUAL and the analgesic response to an opioid medication.(one hour)
- The evolution of the Pupillary Unrest in Ambient Light depending on the type of opioid (morphine versus weak opioid like tramadol) received by the patient.(one hour)
- The correlation between the pain measurements obtained by the reception nurse and that obtained by the patient.(2 minutes)
- The evolution of the pupillary light reflex depending on the type of opioid (morphine versus weak opioid like tramadol) received by the patient.(1 minute)
Investigators
Study Sites (2)
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