Pupil Dilation and Analgesia Nociception Index

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03280238
• Other study ID #: 2016/278
• Status: Completed
• Phase: N/A
• First received: September 5, 2017
• Last updated: September 12, 2017
• Start date: March 1, 2017
• Est. completion date: May 31, 2017

Study information

• Verified date: September 2017
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Mydriasis
• Pain

Intervention

Diagnostic Test:
• Measurement of pupil dilation and analgesia nociception index
painful electrical stimuli of various intensities were administered to the subjects after which changes in pupil diameter and analgesia nociception index were measured

Locations

Country	Name	City	State
Belgium	UZ Brussel	Jette

Sponsors (1)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

Chapman CR, Oka S, Bradshaw DH, Jacobson RC, Donaldson GW. Phasic pupil dilation response to noxious stimulation in normal volunteers: relationship to brain evoked potentials and pain report. Psychophysiology. 1999 Jan;36(1):44-52. — View Citation

Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. — View Citation

Koenig J, Jarczok MN, Ellis RJ, Hillecke TK, Thayer JF. Heart rate variability and experimentally induced pain in healthy adults: a systematic review. Eur J Pain. 2014 Mar;18(3):301-14. doi: 10.1002/j.1532-2149.2013.00379.x. Epub 2013 Aug 6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pupil dilation in relation to pain	measurement of pupil dilation	2sec before until 4sec after each painful stimulus
Secondary	Analgesia nociception index in relation to pain	measurement of analgesia nociception index	30sec before until 60sec after each painful stimulus