Developing a Method to Objectively Measure Opioid Analgesia

NCT03605966 | Active Not Recruiting DMC

• 1 other identifier: 6825
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Analgesics, Antipyretics and Anti-Inflammatory Drugs Causing Adverse Effects in Therapeutic Use

Keywords

analgesia; pain; nociception; pupillometry; analgesic; opioid

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

Eligibility Criteria

• Age: 7 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• The subject is 7 to 21 years of age
• The subject is receiving an opioid via bolus or a patient controlled analgesia (PCA) apparatus as part of treatment or fentanyl infusion in the pediatric intensive care unit (PICU) (generally postoperative patients).
• The subject is willing and able to provide written informed assent/parental consent to study participation

You may not qualify if:

• Eye pathology precluding pupillometry
• For patients in the PICU, patients who are hemodynamically unstable

Sponsors & Collaborators

• Julia Finkel: lead

Study Sites (1)

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Agnosia; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Julia C Finkel, MD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: July 30, 2018
• Study Start: July 1, 2018
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Locations

US (1)