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

Qualifiers

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 design

Treatments tested in this trial

  • AlgometRx Nociometer

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators