Characterization of Acute Pain

Children's National

Status: Enrolling

Conditions: Postoperative Pain; Acute Pain; Acute Pain, Postoperative

Treatments: Device: AlgometRx Nociometer

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07336264

STUDY00001386 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 6 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Surgical Cohort

Description:

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.

Treatment:

Device: AlgometRx Nociometer

Bone Marrow Transplant (BMT) Cohort

Description:

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.

Treatment:

Device: AlgometRx Nociometer