NCT03605966|Active Not RecruitingDMC
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Sponsor study identifier
observational
40
1 country
1
Study Start
July 1, 2018
Actual (reported)Primary Completion
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Inappropriate prescribing is the fundamental upstream driver of the opioid epidemic. Objective measures to determine the appropriateness of an opioid intervention, provide monitoring of the therapy for adequacy of dose and detection of tolerance or hyperalgesia would eliminate the subjective nature of opioid mediated pain management and obviate iatrogenic facilitation of opioid abuse. The present study is designed to objectively determine whether our device can pain type and determine analgesic efficacy thereby optimizing treatment selection and opioid management.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 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.
July 1, 2018
Actual (reported)July 10, 2018
Actual (reported)July 30, 2018
Actual (reported)September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Changes in Pupillary Dilation Reflex AUC
The primary measurable outcomes for this study are the changes in the PRD area under the curve (AUC) that occur as a response to an opioid exposure. The differences are calculated by comparing the parameters from before the opioid dose to various time points after the opioid dose.
0, 15, 30, 45, 60, 90, 120, 180 minutes
Pain Assessment by Visual Analog Scale (VAS)
0, 15, 30, 45, 60, 90, 120, 180 minutes
Pupillary Dilation Reflex Amplitude
0, 15, 30, 45, 60, 90, 120, 180 minutes
Changes in Pupillary Light Reflex Amplitude
0, 15, 30, 45, 60, 90, 120, 180 minutes
Changes in Pupillary Light Reflex Latency
0, 15, 30, 45, 60, 90, 120, 180 minutes
Changes in Pupillary Light Reflex Constriction Velocity
0, 15, 30, 45, 60, 90, 120, 180 minutes
Participants who are receiving opioid as part of their standard care will be recruited from the Inpatient Pain at Children's National Medical Center (CNMC).
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
July 10, 2018
First Posted
July 30, 2018
Study Start
July 1, 2018
Actual (reported)Primary Completion
September 1, 2026
Estimated (date passed)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 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 6, 2026
Record last verified: 2026-04
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Source: ClinicalTrials.gov.
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