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Comparison Between Pupillometry and the Numerical Rating Scale

Primary Purpose

Pain, Acute

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
pupillometry
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pain, Acute focused on measuring pupillometry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • cliniques universitaires Saint-LucRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic Test: pupillometry

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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).
The correlation between the initial measurement of PUAL and the analgesic response to an opioid medication.
The correlation between the pain measurements obtained by the reception nurse and that obtained by the patient.
The evolution of the pupillary light reflex depending on the type of opioid (morphine versus weak opioid like tramadol) received by the patient.

Full Information

First Posted
August 10, 2021
Last Updated
August 24, 2021
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT05019898
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 4, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 4, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute
Keywords
pupillometry

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic Test: pupillometry
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
pupillometry
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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.
Time Frame
one hour
Title
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).
Time Frame
1 minute
Title
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).
Time Frame
1 minute
Title
The correlation between the initial measurement of PUAL and the analgesic response to an opioid medication.
Time Frame
one hour
Title
The correlation between the pain measurements obtained by the reception nurse and that obtained by the patient.
Time Frame
2 minutes
Title
The evolution of the pupillary light reflex depending on the type of opioid (morphine versus weak opioid like tramadol) received by the patient.
Time Frame
1 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
cliniques universitaires Saint-Luc
City
Brussel
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
charles gregoire, MD
Phone
0032497534996
Email
gregoirecharles1@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison Between Pupillometry and the Numerical Rating Scale

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