Recruiting

AlgometRx Nociometer

Sponsor:

Children's National Research Institute

Code:

NCT07336264

Conditions

Acute Pain, Postoperative

Postoperative Pain

Acute Pain

Eligibility Criteria

Sex: All

Age: 6 - 21

Healthy Volunteers: Not accepted

Interventions

AlgometRx Nociometer

Study Details

Brief summary:

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.

Conditions

Acute Pain, Postoperative

Postoperative Pain

Acute Pain

Study ID

NCT07336264

Start date

Dec 2, 2025

Status verified date

Jan, 2026

Completion date

Jun 2, 2028

Anticipated

Primary completion date

Dec 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 21

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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,

Primary outcome measure

  • Nociceptive Index [ Time Frame: Baseline through up to 9 weeks of follow-up ]

Central Contacts and Locations

Central contacts

Julia Finkel, M.D

202-841-0362JFINKEL@childrensnational.org

Shaghayegh Rezalou

216-463-5052srezalou@childrensnational.org

Locations

Children's National Hospital

Recruiting

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

Contacts

Julia Finkel, M.D

2202-841-0362JFINKEL@childrensnational.org

Principal Investigator:

Julia Finkel, M.D

More Information

Sponsor

Children's National Research Institute

Last update posted

Jan 14, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's National Research Institute on 2026-01-14.