Purpose

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.

Condition

Eligibility

Eligible Ages
Between 7 Years and 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Local Anesthetics Lidocaine
N-methyl-D-aspartate Antagonists Ketamine
SNRIs Duloxetine
Alpha-2 adrenergic agonists Dexmedetomidine
Oral Analgesics NSAIDs, acetaminophen
Non-pharmacologic interventions Acupuncture

Recruiting Locations

Children's National and nearby locations

Children's National Health System
Washington, District of Columbia 20010
Contact:
Julia C Finkel, MD
jfinkel@cnmc.org

More Details

NCT ID
NCT03794362
Status
Recruiting
Sponsor
Julia Finkel

Study Contact

Julia C Finkel, MD
2024764867
jfinkel@childrensnational.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.