RECRUITING

Measuring Analgesic Interventions

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

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.

Official Title

Developing a Method to Objectively Measure Analgesic Interventions: A Pilot Study

Quick Facts

Study Start:2018-10-29
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03794362

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 analgesic intervention in the Children's National Medical Center Pain Clinic
  3. 3. The subject is willing and able to provide written informed assent/parental consent to the study participation.
  1. 1. Eye pathology precluding pupillometry
  2. 2. Patients who are actively using opioids (history of use acceptable). Rationale: opioids constrict the pupil, and therefore concomitant opioid use would bias our results.
  3. 3. Subjects who are or may be pregnant

Contacts and Locations

Study Contact

Julia C Finkel, MD
CONTACT
2024764867
jfinkel@childrensnational.org

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 Date2018-10-29
Study Completion Date2024-12

Study Record Updates

Study Start Date2018-10-29
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • analgesia
  • pain
  • nociception
  • pupillometry
  • analgesic

Additional Relevant MeSH Terms

  • Pain