Clinical trial NCT05019898: Comparison Between Pupillometry and the Numerical Rating Scale
Official title: Comparison Between Pupillometry and the Numerical Rating Scale for the Assessment of Pain in Communicating Adult Patients Presenting to the Emergency Room.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Acute
Keywords: pupillometry
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2021-08-25
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 1 minute
Secondary outcomes:
measure: 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.
timeFrame: one hour
measure: 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).
timeFrame: 1 minute
measure: 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).
timeFrame: 1 minute
measure: The correlation between the initial measurement of PUAL and the analgesic response to an opioid medication.
timeFrame: one hour
measure: The correlation between the pain measurements obtained by the reception nurse and that obtained by the patient.
timeFrame: 2 minutes
measure: The evolution of the pupillary light reflex depending on the type of opioid (morphine versus weak opioid like tramadol) received by the patient.
timeFrame: 1 minute
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: cliniques universitaires Saint-Luc
Study officials:
References: