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Comparison Between Pupillometry and the Numerical Rating Scale

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Unknown

Conditions

Pain, Acute

Treatments

Diagnostic Test: pupillometry

Study type

Interventional

Funder types

Other

Identifiers

NCT05019898
PEWC_MAYS2021

Details and patient eligibility

About

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.

Enrollment

320 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

320 participants in 1 patient group

Diagnostic Test: pupillometry
Experimental group
Treatment:
Diagnostic Test: pupillometry

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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