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NCT Number: NCT03794362

Measuring Analgesic Interventions

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.

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Key information

Age range

7 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's National Health System

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

Location status: Recruiting

Location contact

Julia C Finkel, MD

CONTACT

[email protected]

Julia C Finkel, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Pupillary Reflex Dilation (PRD) Area under Curve (AUC)

    Time frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes

    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.

Secondary outcomes

  1. Pupillary Light Reflex (PLR) Latency

    Time frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes

    The changes that occur in PLR Latency 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.

  2. Pupillary Light Reflex (PLR) Amplitude

    Time frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes

    The changes that occur in PLR Amplitude 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.

  3. Pupillary Light Reflex (PLR) Recovery Time

    Time frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes

    The changes that occur in PLR Recovery Time 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.

  4. Pupillary Reflex Dilation (PRD) Amplitude

    Time frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes

    The changes that occur in PRD amplitude 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Julia C Finkel, MD

CONTACT

[email protected]

2024764867

Sponsors and collaborators

Lead sponsor

Julia Finkel

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Jan 7, 2019
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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