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Completed

NCT Number: NCT03280238

Pupil Dilation and Analgesia Nociception Index

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UZ Brussel

Jette, 1090, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • good health
  • no acute or chronic pain conditions
  • well rested

Exclusion criteria

  • chronic treatment
  • bad health
  • daily use of analgetics or other medication
  • weekly tobacco use
  • weekly use of recreational drugs
  • more than 10 alcohol consumptions a week

Treatment and study plan

Measurement of pupil dilation and analgesia nociception index

Diagnostic Test

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

Primary outcomes

  1. Pupil dilation in relation to pain

    Time frame: 2sec before until 4sec after each painful stimulus

    measurement of pupil dilation

Secondary outcomes

  1. Analgesia nociception index in relation to pain

    Time frame: 30sec before until 60sec after each painful stimulus

    measurement of analgesia nociception index

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 12, 2017
Registry last updated
Sep 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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