Comparison Between Pupillometry and the Numerical Rating Scale

NCT ID: NCT05019898

Last Updated: 2021-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-04
• Study Completion Date: 2022-08-04

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.

Conditions

Pain, Acute

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic Test: pupillometry

Group Type: EXPERIMENTAL

pupillometry

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

cliniques universitaires Saint-Luc

Brussels, , Belgium

Site Status: RECRUITING

Countries

Belgium

Facility Contacts

charles gregoire, MD

Role: primary

gregoirecharles1@gmail.com

0032497534996

References

Gregoire C, Charier D, de Bergeyck R, Mouraux A, Van Ouytsel F, Lambert R, Zhou N, Lavand'homme P, Penaloza A, Pickering G. Comparison between pupillometry and numeric pain rating scale for pain assessments in communicating adult patients in the emergency department. Eur J Pain. 2023 Sep;27(8):952-960. doi: 10.1002/ejp.2137. Epub 2023 Jun 11.

Reference Type: DERIVED

PMID: 37303073 (View on PubMed)

Other Identifiers

PEWC_MAYS2021

Identifier Type: -

Identifier Source: org_study_id