Acute Pain, PostoperativeNCT07336264
Characterization of Acute Pain
An observational study of Acute Pain, Postoperative and Postoperative Pain, run by Children's National Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 21 years
- Conditions the study is for
- Acute Pain, Postoperative, Postoperative Pain, Acute Pain
- What is being tested?
- AlgometRx Nociometer
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2025to 2 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Documented history of eye disease that precludes pupillometry
- Unwilling or unable to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010
Julia Finkel, M.D, 2202-841-0362, JFINKEL@childrensnational.org
Julia Finkel, M.D
About this study
Official title: Characterization of Acute Nociceptive Pain and Analgesic Response in Pediatric and Adolescent Patients
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.
- Conditions
- Acute Pain, Postoperative, Postoperative Pain, Acute Pain
- Being tested
- AlgometRx Nociometer
- Medical subject headings
- Pain, Postoperative, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlgometRx NociometerDevice
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,
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: AlgometRx Nociometer | |
| 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. Receives: Device: AlgometRx Nociometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline through up to 9 weeks of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start2 Dec 2025
- Primary completion2 Dec 2027 (estimated)
- Study completion2 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acute Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- VentureWell
- Responsible party
- Principal investigator, Julia Finkel, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336264
- Sponsor's protocol ID
- STUDY00001386
- Other IDs
- STUDY00001386
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2026
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Publications
Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
PubMed 8080219Instrument: PROMIS Pain Intensity - Short Form 3a v1.0 | NIDA CTN Common Data Elements. https://cde.nida.nih.gov/instrument/0a481bfb-a5e6-3c84-e050-bb89ad43314d
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.
PubMed 22424915Wong-Baker FACES® Pain Rating Scale. (2016)
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.
PubMed 23842524Barr 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.
PubMed 22744222Chouchou 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.
PubMed 33741256Crawford 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.
PubMed 36069972Minetama 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.
PubMed 36096768Fomberstein 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.
PubMed 23995063
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Acute Nociceptive Pain and Analgesic Response in Pediatric and Adolescent Patients
- ClinicalTrials.gov ID
- NCT07336264
- Acronym / sponsor ID
- STUDY00001386
- Conditions
- Acute Pain, Postoperative, Postoperative Pain, Acute Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Collaborators
- VentureWell
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- 2 Dec 2027 (estimated)
- Study completion
- 2 Jun 2028 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Cohort | – | Device: AlgometRx NociometerChildren 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. |
| Bone Marrow Transplant (BMT) Cohort | – | Device: AlgometRx NociometerChildren 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. |
Who may qualify
- Ages
- 6 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Documented history of eye disease that precludes pupillometry
- Unwilling or unable to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlgometRx NociometerThe 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, | Device | Bone Marrow Transplant (BMT) Cohort, Surgical Cohort |
Primary outcome
Nociceptive Index
Time frame: Baseline through up to 9 weeks of follow-up
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Background: PubMed 8080219Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
- BackgroundInstrument: PROMIS Pain Intensity - Short Form 3a v1.0 | NIDA CTN Common Data Elements. https://cde.nida.nih.gov/instrument/0a481bfb-a5e6-3c84-e050-bb89ad43314d
- Background: PubMed 22424915Page 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.
- BackgroundWong-Baker FACES® Pain Rating Scale. (2016)
- Background: PubMed 23842524Lavoie 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.
- Background: PubMed 22744222Barr 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.
- Background: PubMed 33741256Chouchou 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.
- Background: PubMed 36069972Crawford 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.
- Background: PubMed 36096768Minetama 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.
- Background: PubMed 23995063Fomberstein 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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pain, Postoperative and Postoperative Pain, run by Children's National Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia Finkel, M.D (202-841-0362, JFINKEL@childrensnational.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nociceptive Index (time frame: Baseline through up to 9 weeks of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07336264, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026; AzTrials last refreshed its copy on 26 Oct 2026.