Characterization of Acute Pain
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 evalua
| Condition(s) | Acute Pain, Postoperative, Postoperative Pain, Acute Pain |
|---|---|
| Status | Recruiting |
| 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 hospit |
| Who can participate | 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 |
| Ages | 6 Years to 21 Years |
| Sex | All |
| Lead sponsor | Children's National Research Institute |
| Locations | Washington D.C., District of Columbia, United States |
| Start date | 2025-12-02 |
| NCT ID | NCT07336264 |
| Official listing | https://clinicaltrials.gov/study/NCT07336264 |