NCT07336264

Characterization of Acute Pain

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Children's National Research Institute · Academic / Other
• Sex: All
• Age: 6 Years – 21 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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,

Timeline

• Start date: 2025-12-02
• Primary completion: 2027-12-02
• Completion: 2028-06-02
• First posted: 2026-01-13
• Last updated: 2026-01-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study