Measuring Analgesic Interventions

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Julia Finkel
Study ID
NCT03794362
Status
Recruiting
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Conditions

  • Pain

Eligibility Criteria

Sex
ALL
Age
7 Years - 21 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Oct 29, 2018
Status verified
Apr 2026
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
120 participants (estimated)

Arms

  • Arm: Local Anesthetics
    Lidocaine
  • Arm: N-methyl-D-aspartate Antagonists
    Ketamine
  • Arm: SNRIs
    Duloxetine
  • Arm: Alpha-2 adrenergic agonists
    Dexmedetomidine
  • Arm: Oral Analgesics
    NSAIDs, acetaminophen
  • Arm: 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

Locations (1)

FacilityCityStateZIPSite coordinators
Children's National Health SystemWashington D.C.District of Columbia20010
Julia C Finkel, MD
[email protected]
Julia C Finkel, MD (PRINCIPAL_INVESTIGATOR)

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Children's National Health System· Washington D.C., DC

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