Pain, AcuteNCT05019898
Comparison Between Pupillometry and the Numerical Rating Scale
A study testing pupillometry in people with Pain, Acute, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Acute
- What is being tested?
- pupillometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Aug 2021to 4 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients presenting to the emergency room, aged 18 years or over, able to communicate, with hemodynamic and respiratory stability, are eligible.
Who cannot join
- - 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.
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- 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 locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
cliniques universitaires Saint-Luc
Brussels, 1200
charles gregoire, MD, 0032497534996, gregoirecharles1@gmail.com
About this study
Official title: 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.
- Conditions
- Pain, Acute
- Being tested
- pupillometry
- Keywords
- pupillometry
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pupillometryDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Test: pupillometry | Experimental | Not described Receives: Diagnostic Test: pupillometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 minute
Secondary outcomes (6)
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.
Measured: 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).
Measured: 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).
Measured: 1 minute
The correlation between the initial measurement of PUAL and the analgesic response to an opioid medication.
Measured: one hour
The correlation between the pain measurements obtained by the reception nurse and that obtained by the patient.
Measured: 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.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start4 Aug 2021
- Primary completion1 Aug 2022 (estimated)
- Study completion4 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019898
- Sponsor's protocol ID
- PEWC_MAYS2021
- Status last verified
- Aug 2021
- First submitted
- 10 Aug 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37303073
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Pupillometry and the Numerical Rating Scale for the Assessment of Pain in Communicating Adult Patients Presenting to the Emergency Room.
- ClinicalTrials.gov ID
- NCT05019898
- Acronym / sponsor ID
- PEWC_MAYS2021
- Conditions
- Pain, Acute
- Keywords
- pupillometry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 4 Aug 2022 (estimated)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Test: pupillometry | Experimental | Diagnostic Test: pupillometry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients presenting to the emergency room, aged 18 years or over, able to communicate, with hemodynamic and respiratory stability, are eligible.
Key exclusion criteria (15 listed)
- - 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pupillometryStep 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. | Diagnostic test | Diagnostic Test: pupillometry |
Primary outcome
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
6 secondary outcomes
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
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
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
The correlation between the initial measurement of PUAL and the analgesic response to an opioid medication.
Time frame: one hour
The correlation between the pain measurements obtained by the reception nurse and that obtained by the patient.
Time frame: 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.
Time frame: 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Derived from this study: PubMed 37303073Gregoire 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pupillometry in people with Pain, Acute, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05019898, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.