Characterization of Acute Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-21
SponsorChildren's National Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Documented history of eye disease that precludes pupillometry
Unwilling or unable to participate
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
AlgometRx Nociometer
DeviceThe 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,
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Surgical Cohort1 intervention
Group B: Bone Marrow Transplant (BMT) Cohort1 intervention
Trial outcomes
Primary outcomes
1
Nociceptive Index
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.
Time frame
Baseline through up to 9 weeks of follow-upSponsors and contacts
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Children's National Research Institute
Lead sponsor
VentureWell
Collaborator
Source ClinicalTrials.gov