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| ID | Type | Description | Link |
|---|---|---|---|
| STUDY00001386 | Other Identifier | Childrens National IRB Protocol Number |
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| Name | Class |
|---|---|
| VentureWell | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical Cohort | 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. |
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| Bone Marrow Transplant (BMT) Cohort | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AlgometRx Nociometer | Device | The AlgometRx Nociometer is a non-invasive device used to measure nociceptive responses through neuroselective electrical stimulation and pupillometry. The device delivers low-intensity, painless electrical stimuli at specific frequencies to selectively activate sensory nerve fibers, while measuring stimulus-induced changes in pupil diameter. Data generated by the device are used or research measurement purposes only and do not guide or alter clinical care, treatment decisions, |
| Measure | Description | Time Frame |
|---|---|---|
| Nociceptive Index | The nociceptive index calculated from neuroselective stimulus-induced pupillary reflex dilation (nPRD) measurements obtained using the AlgometRx Nociometer. The index is derived from the area under the curve (AUC) of pupillary dilation responses corresponding to selective activation of sensory nerve fiber types and is used to characterize acute nociceptive pain. | Baseline through up to 9 weeks of follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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The study population includes children and adolescents ages 6 to 21 years receiving care at Children's National Hospital who are either undergoing elective surgical procedures or bone marrow transplantation. Participants will be followed prospectively and undergo non-invasive nociceptive measurements during routine clinical care, including periods before and after procedures and during inpatient follow-up. The study does not alter clinical management, and all treatments are provided according to standard of care.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julia Finkel, M.D | Contact | 202-841-0362 | JFINKEL@childrensnational.org | |
| Shaghayegh Rezalou | Contact | 216-463-5052 | srezalou@childrensnational.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's National Hospital | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8080219 | Background | Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38. | |
| Background | Instrument: PROMIS Pain Intensity - Short Form 3a v1.0 | NIDA CTN Common Data Elements. https://cde.nida.nih.gov/instrument/0a481bfb-a5e6-3c84-e050-bb89ad43314d | ||
| 22424915 |
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De-identified individual participant data underlying the results reported in publications, including nociceptive index measurements, standard pain assessment scores, and relevant clinical variables. Direct identifiers will not be shared.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Background |
| Page MG, Katz J, Stinson J, Isaac L, Martin-Pichora AL, Campbell F. Validation of the numerical rating scale for pain intensity and unpleasantness in pediatric acute postoperative pain: sensitivity to change over time. J Pain. 2012 Apr;13(4):359-69. doi: 10.1016/j.jpain.2011.12.010. Epub 2012 Mar 15. |
| Background | Wong-Baker FACES® Pain Rating Scale. (2016) |
| 23842524 | Background | Lavoie Smith EM, Li L, Hutchinson RJ, Ho R, Burnette WB, Wells E, Bridges C, Renbarger J. Measuring vincristine-induced peripheral neuropathy in children with acute lymphoblastic leukemia. Cancer Nurs. 2013 Sep-Oct;36(5):E49-60. doi: 10.1097/NCC.0b013e318299ad23. |
| 22744222 | Background | Barr MS, Farzan F, Davis KD, Fitzgerald PB, Daskalakis ZJ. Measuring GABAergic inhibitory activity with TMS-EEG and its potential clinical application for chronic pain. J Neuroimmune Pharmacol. 2013 Jun;8(3):535-46. doi: 10.1007/s11481-012-9383-y. Epub 2012 Jun 29. |
| 33741256 | Background | Chouchou F, Perchet C, Garcia-Larrea L. EEG changes reflecting pain: is alpha suppression better than gamma enhancement? Neurophysiol Clin. 2021 Jun;51(3):209-218. doi: 10.1016/j.neucli.2021.03.001. Epub 2021 Mar 16. |
| 36069972 | Background | Crawford L, Mills E, Meylakh N, Macey PM, Macefield VG, Henderson LA. Brain activity changes associated with pain perception variability. Cereb Cortex. 2023 Mar 21;33(7):4145-4155. doi: 10.1093/cercor/bhac332. |
| 36096768 | Background | Minetama M, Kawakami M, Teraguchi M, Matsuo S, Enyo Y, Nakagawa M, Yamamoto Y, Nakatani T, Sakon N, Nagata W, Nakagawa Y. MRI grading of spinal stenosis is not associated with the severity of low back pain in patients with lumbar spinal stenosis. BMC Musculoskelet Disord. 2022 Sep 12;23(1):857. doi: 10.1186/s12891-022-05810-y. |
| 23995063 | Background | Fomberstein K, Qadri S, Ramani R. Functional MRI and pain. Curr Opin Anaesthesiol. 2013 Oct;26(5):588-93. doi: 10.1097/01.aco.0000433060.59939.fe. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |