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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 21
Healthy Volunteers: f
View:

• 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

Locations
United States
Washington, D.c.
Children's National Hospital
RECRUITING
Washington D.c.
Contact Information
Primary
Julia Finkel, M.D
JFINKEL@childrensnational.org
202-841-0362
Backup
Shaghayegh Rezalou
srezalou@childrensnational.org
216-463-5052
Time Frame
Start Date: 2025-12-02
Estimated Completion Date: 2028-06-02
Participants
Target number of participants: 100
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Children's National Research Institute
Collaborators: VentureWell

This content was sourced from clinicaltrials.gov

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