Acute Pain, Acute Pain, Postoperative, Postoperative Pain
Conditions
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.
Interventions
DEVICEAlgometRx 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,
Sponsors
VentureWell
Children's National Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nociceptive Index | 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. |
Countries
United States
Contacts
Primary ContactJulia Finkel, M.D
Backup ContactShaghayegh Rezalou
Outcome results
None listed