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Understanding Acute Pain in Children and Adolescents

This study aims to better understand how acute pain is measured and how children and adolescents respond to pain treatment. Currently, pain is often assessed through self-reports or observation, which can be challenging to interpret, especially in younger patients. This study will evaluate a new, non-invasive device called the AlgometRx Nociometer. This device measures changes in pupil size in response to gentle electrical stimulation, which helps show how pain-related nerves are working. We hope this device can provide a more objective way to measure pain. Participants, aged 6 to 21 years, will be those undergoing elective surgery or bone marrow transplantation at Children's National Hospital. The main goal is to measure a "Nociceptive Index" (a measure of pain response) from the start of the study through up to 9 weeks of follow-up.

Study design
This is an observational study with a planned enrollment of 100 participants. It is not testing a new treatment, but rather how a device measures pain.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 9 weeks after the start of the study.

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NCT07336264

Characterization of Acute Pain

Recruiting
Not specifiedAges 6–21Observational
Children's National Research Institute
~100 participants
Updated 2026-01-14 on ClinicalTrials.gov
What's tested:AlgometRx Nociometer

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Nociceptive Index
Measured over Baseline through up to 9 weeks of follow-up

Conditions

Acute Pain, Postoperative
Postoperative Pain
Acute Pain

Explore related trials

Acute PainPost-Operative Pain

Where it's being run

1 sites across 1 states
District of Columbia1

Who to contact

Julia Finkel, M.D
[email protected]
202-841-0362
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Eligibility criteria

Inclusion

Children and adolescents ages 6 to 21 years
Undergoing elective surgical procedures without a history of chronic pain, OR undergoing or planning to undergo bone marrow transplantation (BMT)
Able to provide written informed assent and parental permission/consent, as applicable

Exclusion

Documented history of eye disease that precludes pupillometry
Unwilling or unable to participate

What this trial measures

  • Nociceptive IndexBaseline through up to 9 weeks of follow-up

    The nociceptive index calculated from neuroselective stimulus-induced pupillary reflex dilation (nPRD) measurements obtained using the AlgometRx Nociometer. The index is derived from the area under the curve (AUC) of pupillary dilation responses corresponding to selective activation of sensory nerve fiber types and is used to characterize acute nociceptive pain.