Measuring Analgesic Interventions

NCT03794362 | Recruiting DMC

• 1 other identifier: 9586
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Keywords

analgesia; pain; nociception; pupillometry; analgesic

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

Study Arms (6)

Local Anesthetics

Lidocaine

N-methyl-D-aspartate Antagonists

Ketamine

SNRIs

Duloxetine

Alpha-2 adrenergic agonists

Dexmedetomidine

Oral Analgesics

NSAIDs, acetaminophen

Non-pharmacologic interventions

Acupuncture

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

Patients who are receiving pharmacological or non-pharmacological analgesic interventions as part of their regularly occurring clinical treatment.

You may qualify if:

• The subject is 7 to 21 years of age
• The subject is receiving an analgesic intervention in the Children's National Medical Center Pain Clinic
• The subject is willing and able to provide written informed assent/parental consent to the study participation.

You may not qualify if:

• Eye pathology precluding pupillometry
• Patients who are actively using opioids (history of use acceptable). Rationale: opioids constrict the pupil, and therefore concomitant opioid use would bias our results.
• Subjects who are or may be pregnant

Sponsors & Collaborators

• Julia Finkel: lead

Study Sites (1)

Children's National Health System

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

RECRUITING

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

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

Study Officials

• Julia C Finkel, MD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia C Finkel, MD

CONTACT

2024764867; jfinkel@childrensnational.org

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: October 31, 2018
• First Posted: January 7, 2019
• Study Start: October 29, 2018
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

US (1)