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NCT Number: NCT07336264

Characterization of Acute Pain

This study aims to better understand how acute pain and responses to pain treatment can be measured in children and adolescents using a non-invasive device. Pain is usually assessed using self-reported or observational scales, which can be difficult to interpret, especially in pediatric patients. This study will evaluate whether a novel device, the AlgometRx Nociometer, can provide an objective measure of nociceptive pain. Participants ages 6 to 21 years who are undergoing elective surgery or bone marrow transplantation will be enrolled at Children's National Hospital. The device measures changes in pupil size in response to gentle electrical stimulation, which reflects activity in pain-related nerve pathways. Measurements will be taken before and after procedures and during routine hospital care, alongside standard pain assessments. This is an observational study. Participation will not change or guide any medical treatment, and all pain management will follow standard clinical care. The information collected may help improve future pain assessment and treatment for pediatric patients.

Recruiting

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Key information

Age range

6 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's National Hospital

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

Location status: Recruiting

Location contact

Julia Finkel, M.D

CONTACT

[email protected]

2202-841-0362

Julia Finkel, M.D

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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 criteria

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

Treatment and study plan

AlgometRx Nociometer

Device

The AlgometRx Nociometer is a non-invasive device used to measure nociceptive responses through neuroselective electrical stimulation and pupillometry. The device delivers low-intensity, painless electrical stimuli at specific frequencies to selectively activate sensory nerve fibers, while measuring stimulus-induced changes in pupil diameter. Data generated by the device are used or research measurement purposes only and do not guide or alter clinical care, treatment decisions,

Primary outcomes

  1. Nociceptive Index

    Time frame: Baseline 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.

Study contacts

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

Julia Finkel, M.D

CONTACT

[email protected]

202-841-0362

Shaghayegh Rezalou

CONTACT

[email protected]

216-463-5052

Sponsors and collaborators

Lead sponsor

Children's National Research Institute

Other

Collaborators

  • VentureWell

Registry information

Official study title

Characterization of Acute Nociceptive Pain and Analgesic Response in Pediatric and Adolescent Patients

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 13, 2026
Registry last updated
Jan 14, 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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