Measuring Analgesic Interventions
Developing a Method to Objectively Measure Analgesic Interventions: A Pilot Study
Developing a Method to Objectively Measure Analgesic Interventions: A Pilot Study
Sponsor study identifier
observational
120
1 country
1
Study Start
October 29, 2018
Actual (reported)Primary Completion
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
It is generally recognized that pain assessment and management especially in newborns, children and other nonverbal populations is an unmet need. According to the American Medical Association, "the pediatric population is at risk of inadequate pain management, with age-related factors affecting pain management in children. Children are often given minimal or no analgesia for procedures that would routinely be treated aggressively in adults. Although much is now known about pain management in children, it has not been widely or effectively translated into routine clinical practice". These two factors combine to emphasize the necessity for an objective tool to quantify pain and monitor the effectiveness of analgesia, especially during treatments. Further, it is reported that many patients require a combination of treatments, and it is often necessary to test a variety of treatments before the personal match for treatment is found. The method in place to change the care on a subjective basis is difficult, time consuming, and not easily individualized. This pilot study is part of an ongoing effort to develop a method to objectively assess response to specific analgesic interventions. It specifically aims to discern the impact of analgesic interventions on sensory nerve fiber sensitivity in a diverse patient population.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 29, 2018
Actual (reported)October 31, 2018
Actual (reported)January 7, 2019
Actual (reported)September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Pupillary Reflex Dilation (PRD) Area under Curve (AUC)
The changes that occur in PRD AUC as a response to an analgesic intervention will be investigated. The differences are calculated by comparing the parameters from before the intervention to after the intervention.
0, 15, 30, 45, 60, 90, 120, 180 minutes
Pupillary Light Reflex (PLR) Latency
0, 15, 30, 45, 60, 90, 120, 180 minutes
Pupillary Light Reflex (PLR) Amplitude
0, 15, 30, 45, 60, 90, 120, 180 minutes
Pupillary Light Reflex (PLR) Recovery Time
0, 15, 30, 45, 60, 90, 120, 180 minutes
Pupillary Reflex Dilation (PRD) Amplitude
0, 15, 30, 45, 60, 90, 120, 180 minutes
Lidocaine
Ketamine
Duloxetine
Dexmedetomidine
NSAIDs, acetaminophen
Acupuncture
Patients who are receiving pharmacological or non-pharmacological analgesic interventions as part of their regularly occurring clinical treatment.
Children's National Health System
Washington D.C., District of Columbia, 20010, United States
Julia C Finkel, MD
Children's National Research Institute
First Submitted
October 31, 2018
First Posted
January 7, 2019
Study Start
October 29, 2018
Actual (reported)Primary Completion
September 2026
Estimated (date passed)Communication and Activation in Pain to Enhance Relationships and Treat Pain With Equity
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 7, 2026
Record last verified: 2026-04
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Source: ClinicalTrials.gov.
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