ACTIVE_NOT_RECRUITING

Developing a Method to Objectively Measure Opioid Analgesia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Developing a Method to Objectively Measure Opioid Analgesia: A Pilot Study

Quick Facts

Study Start:2018-07-01
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03605966

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:7 Years to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. The subject is 7 to 21 years of age
  2. 2. 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).
  3. 3. The subject is willing and able to provide written informed assent/parental consent to study participation
  1. 1. Eye pathology precluding pupillometry
  2. 2. For patients in the PICU, patients who are hemodynamically unstable

Contacts and Locations

Principal Investigator

Julia C Finkel, MD
PRINCIPAL_INVESTIGATOR
Children's National Health System

Study Locations (Sites)

Children's National Health System
Washington, District of Columbia, 20010
United States

Collaborators and Investigators

Sponsor: Julia Finkel

  • Julia C Finkel, MD, PRINCIPAL_INVESTIGATOR, Children's National Health System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-07-01
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2018-07-01
Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

  • analgesia
  • pain
  • nociception
  • pupillometry
  • analgesic
  • opioid

Additional Relevant MeSH Terms

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