Comparison Between Pupillometry and the Numerical Rating Scale

Pain, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05019898
• Other study ID #: PEWC_MAYS2021
• Status: Recruiting
• Phase: N/A
• Start date: August 4, 2021
• Est. completion date: August 4, 2022

Study information

• Verified date: August 2021
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: August 4, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Pain, Acute

Intervention

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.

Locations

Country	Name	City	State
Belgium	cliniques universitaires Saint-Luc	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	The correlation between the initial measurement of PUAL and the analgesic response to an opioid medication.		one hour
Secondary	The correlation between the pain measurements obtained by the reception nurse and that obtained by the patient.		2 minutes
Secondary	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