Comparison Between Pupillometry and the Numerical Rating Scale

Comparison Between Pupillometry and the Numerical Rating Scale for the Assessment of Pain in Communicating Adult Patients Presenting to the Emergency Room.

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 Overview

• Status: Recruiting
• Conditions: Pain, Acute
• Intervention / Treatment: Diagnostic test: pupillometry

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussel, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires Saint-Luc
    • Contact: charles gregoire, MD; Phone Number: 0032497534996; Email: gregoirecharles1@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Diagnostic Test: pupillometry

Diagnostic test: pupillometry; Step 1: The triage will be carried out by the nurse. The nurse will then perform a self-assessment of the patient's pain using a simple verbal scale. The nurse will then record the patient's self-assessment of his pain using the numeric scale for pain. Step 2: Immediately after this first assessment, eligible patients will be approached by the study investigator to be included in the study. Step 3: If the patient gives informed consent, the study investigator will perform; The quantification of their anxiety; An assessment of pain by a NeuroLight videopupillometer (iDmed, Marseille, France) using two dynamic tests, the Pupillary Unrest in Ambient Light (PUAL) and the pupillary light reflex. Step 4: One hour after the triage, a second pain assessment will be performed. Step 5: The same pupillometry measurements will be taken immediately after the nurse has assessed the pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	1 minute

Secondary Outcome Measures

Outcome Measure	Time Frame
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 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 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 correlation between the initial measurement of PUAL and the analgesic response to an opioid medication.	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

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2021
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 4, 2022

Study Registration Dates

• First Submitted: August 10, 2021
• First Submitted That Met QC Criteria: August 24, 2021
• First Posted (Actual): August 25, 2021

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: pupillometry
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: PEWC_MAYS2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No