| NCT ID | NCT07336264 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's National Research Institute |
| Condition | Acute Pain, Postoperative |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-12-02 |
| Primary Completion | 2027-12-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-12-02 with a primary completion date of 2027-12-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07336264 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 21 Years, studying Acute Pain, Postoperative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07336264 currently recruiting?
Yes, NCT07336264 is actively recruiting participants. Contact the research team at JFINKEL@childrensnational.org for enrollment information.
Where is the NCT07336264 trial being conducted?
This trial is being conducted at Washington D.C., United States.
Who is sponsoring the NCT07336264 clinical trial?
NCT07336264 is sponsored by Children's National Research Institute. The trial plans to enroll 100 participants.