Characterization of Acute Pain

January 12, 2026 updated by: Julia Finkel, Children's National Research Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • Children's National Hospital
        • Contact:
        • Principal Investigator:
          • Julia Finkel, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population includes children and adolescents ages 6 to 21 years receiving care at Children's National Hospital who are either undergoing elective surgical procedures or bone marrow transplantation. Participants will be followed prospectively and undergo non-invasive nociceptive measurements during routine clinical care, including periods before and after procedures and during inpatient follow-up. The study does not alter clinical management, and all treatments are provided according to standard of care.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgical Cohort
Children and adolescents ages 6 to 21 years undergoing elective surgical procedures (e.g., orthopedic or thoracic surgery) with no history of chronic pain prior to surgery. Participants will undergo non-invasive nociceptive measurements using the AlgometRx Nociometer at baseline and during postoperative follow-up, alongside standard clinical pain assessments. All pain management will follow standard of care and will not be influenced by study participation.
Device: AlgometRx Nociometer
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,
Bone Marrow Transplant (BMT) Cohort
Children and adolescents aged 6 to 21 years undergoing elective surgical procedures (e.g., orthopedic or thoracic surgery) with no history of chronic pain before surgery. Participants will undergo non-invasive nociceptive measurements using the AlgometRx Nociometer at baseline and during postoperative follow-up, alongside standard clinical pain assessments. All pain management will follow the standard of care and will not be influenced by study participation.
Device: AlgometRx Nociometer
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,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline through up to 9 weeks of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's National Research Institute

Collaborators

VentureWell

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2025

Primary Completion (Estimated)

December 2, 2027

Study Completion (Estimated)

June 2, 2028

Study Registration Dates

First Submitted

January 2, 2026

First Submitted That Met QC Criteria

January 2, 2026

First Posted (Estimated)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001386 (Other Identifier: Childrens National IRB Protocol Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data underlying the results reported in publications, including nociceptive index measurements, standard pain assessment scores, and relevant clinical variables. Direct identifiers will not be shared.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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