Recruiting

Analgesic Interventions

Sponsor:

Julia Finkel

Code:

NCT03794362

Conditions

Pain

Eligibility Criteria

Sex: All

Age: 7 - 21

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT03794362

Start date

Oct 29, 2018

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. Eye pathology precluding pupillometry
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. Subjects who are or may be pregnant

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

Local Anesthetics

Lidocaine

N-methyl-D-aspartate Antagonists

Ketamine

SNRIs

Duloxetine

Alpha-2 adrenergic agonists

Dexmedetomidine

Oral Analgesics

NSAIDs, acetaminophen

Non-pharmacologic interventions

Acupuncture

Primary outcome measure

  • Pupillary Reflex Dilation (PRD) Area under Curve (AUC) [ Time Frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes ]

Central Contacts and Locations

Central contacts

Locations

Children's National Health System

Recruiting

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

Contacts

Julia C Finkel, MD

jfinkel@cnmc.org

Principal Investigator:

Julia C Finkel, MD

More Information

Sponsor

Julia Finkel

Last update posted

Apr 7, 2026

Last verified

Apr, 2026

Keywords

  • analgesia
  • pain
  • nociception
  • pupillometry
  • analgesic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Julia Finkel on 2026-04-07.