CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 19 enrolled
Drug / intervention
Measurement of pupil dilation and analgesia nociception indexother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03280238
NCT03280238N/ACompleted

Do Pupil Dilation and Analgesia Nociception Index Reflect Pain: a Pilot Study in Healthy, Conscious Volunteers

Vrije Universiteit Brussel·interventional·Posted Sep 12, 2017·Updated Sep 13, 2017

In Brief

A clinical study evaluating Measurement of pupil dilation and analgesia nociception index for Pain. Completed, enrolled 19 participants across 1 site.

Detailed Summary

Pain assessment is crucial in clinical practice. Currently, subjective self-report is considered the most appropriate method to evaluate pain. Although several methods to assess pain objectively exist, the lack of a golden standard still remains. This pilot study assesses the changes in pupil dilation (PD) and the analgesia nociception index (ANI) as a measure of pain in healthy, conscious, male volunteers in a highly standardized and individualized environment. Nineteen subjects received three blocks of 4 individualized electrical stimulus intensities, ranging from no to severe pain. Subjects reported their perceived severity of each individual stimulus, enabling the comparison of changes in PD and ANI in relation to both administered stimulus intensities and perceived pain severities. PD and ANI were measured before and after each administration of a stimulus.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesBelgium
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedSep 12, 2017
Enrollment StartMar 1, 2017
Primary CompletionMay 31, 2017
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 8.8 years ago

Interventions

Measurement of pupil dilation and analgesia nociception indexother

painful electrical stimuli of various intensities were administered to the subjects after which changes in pupil diameter and analgesia nociception index were measured