Characterization of Acute Nociceptive Pain and Analgesic Response in Pediatric and Adolescent Patients
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Children's National Research Institute
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Nociceptive Index
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 6 Years to 21 Years (Child, Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: AlgometRx Nociometer (Device)
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.
Intervention: AlgometRx Nociometer (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Julia Finkel
Vice chief for Pain Medicine and Research
Children's National Research Institute