Using pupillometry to measure acute pain in children and teens
Characterization of Acute Nociceptive Pain and Analgesic Response in Pediatric and Adolescent Patients
This project will test whether a non-invasive pupillometry device (AlgometRx Nociometer) can provide an objective measure of acute pain in children and adolescents ages 6 to 21 who are having elective surgery or undergoing bone marrow transplantation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 6 Years to 21 Years |
| Sex | All |
| Sponsor | Children's National Research Institute Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT07336264 on ClinicalTrials.gov |
What this trial studies
This observational study will enroll patients aged 6–21 at Children's National Hospital who are undergoing elective surgical procedures or bone marrow transplantation. The AlgometRx Nociometer measures changes in pupil size in response to gentle electrical stimulation as a potential objective signal of nociceptive activity. Measurements will be taken before and after procedures and during routine hospital care alongside standard self-report and observational pain scales. Participation does not change clinical pain management and is limited to recording device and clinical assessment data.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 6 to 21 who can provide assent (with parental consent as required) and are undergoing elective surgery without chronic pain or are undergoing/planning bone marrow transplantation, and who do not have eye conditions that prevent pupillometry.
Not a fit: Patients with documented eye disease that precludes pupillometry, those with chronic pain outside the eligibility criteria, or those not receiving care at the enrolling hospital are unlikely to gain direct benefit from this observational protocol.
Why it matters
Potential benefit: If successful, the device could give clinicians a reliable, objective way to measure pain in children and help tailor pain relief more accurately.
How similar studies have performed: Pupillary response monitoring and nociception indices have shown promise in adult studies, but applying objective pupillometry in pediatric perioperative and transplant populations is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Washington D.C., District of Columbia
- Children's National Hospital — Washington D.C., District of Columbia, United States (Recruiting)
Study contacts
- Study coordinator: Julia Finkel, M.D
- Email: JFINKEL@childrensnational.org
- Phone: 202-841-0362
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.