PainNCT03794362
Measuring Analgesic Interventions
An observational study of Pain, run by Julia Finkel at 1 site in United States.
Trial summary
It is generally recognized that pain assessment and management especially in newborns, children and other nonverbal populations is an unmet need. According to the American Medical Association, "the pediatric population is at risk of inadequate pain management, with age-related factors affecting pain management in… Read more about this study
- Who is it for?
- Ages 7 to 21 years
- Conditions the study is for
- Pain
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2018to Dec 2026
- 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 7 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients who are receiving pharmacological or non-pharmacological analgesic interventions as part of their regularly occurring clinical treatment.
Who may be able to join
- The subject is 7 to 21 years of age
- The subject is receiving an analgesic intervention in the Children's National Medical Center Pain Clinic
- The subject is willing and able to provide written informed assent/parental consent to the study participation.
Who cannot join
- Eye pathology precluding pupillometry
- Patients who are actively using opioids (history of use acceptable). Rationale: opioids constrict the pupil, and therefore concomitant opioid use would bias our results.
- Subjects who are or may be pregnant
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 Health System
Washington D.C., District of Columbia, 20010
Julia C Finkel, MD, jfinkel@cnmc.org
Julia C Finkel, MD
About this study
Official title: Developing a Method to Objectively Measure Analgesic Interventions: A Pilot Study
It is generally recognized that pain assessment and management especially in newborns, children and other nonverbal populations is an unmet need. According to the American Medical Association, "the pediatric population is at risk of inadequate pain management, with age-related factors affecting pain management in children. Children are often given minimal or no analgesia for procedures that would routinely be treated aggressively in adults. Although much is now known about pain management in children, it has not been widely or effectively translated into routine clinical practice". These two factors combine to emphasize the necessity for an objective tool to quantify pain and monitor the effectiveness of analgesia, especially during treatments. Further, it is reported that many patients require a combination of treatments, and it is often necessary to test a variety of treatments before the personal match for treatment is found. The method in place to change the care on a subjective basis is difficult, time consuming, and not easily individualized. This pilot study is part of an ongoing effort to develop a method to objectively assess response to specific analgesic interventions. It specifically aims to discern the impact of analgesic interventions on sensory nerve fiber sensitivity in a diverse patient population.
- Conditions
- Pain
- Keywords
- analgesia, pain, nociception, pupillometry, analgesic
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Local Anesthetics | Lidocaine | |
| N-methyl-D-aspartate Antagonists | Ketamine | |
| SNRIs | Duloxetine | |
| Alpha-2 adrenergic agonists | Dexmedetomidine | |
| Oral Analgesics | NSAIDs, acetaminophen | |
| Non-pharmacologic interventions | Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupillary Reflex Dilation (PRD) Area under Curve (AUC)
The changes that occur in PRD AUC as a response to an analgesic intervention will be investigated. The differences are calculated by comparing the parameters from before the intervention to after the intervention.
Measured: 0, 15, 30, 45, 60, 90, 120, 180 minutes
Secondary outcomes (4)
Pupillary Light Reflex (PLR) Latency
The changes that occur in PLR Latency as a response to an analgesic intervention will be investigated. The differences are calculated by comparing the parameters from before the intervention to after the intervention.
Measured: 0, 15, 30, 45, 60, 90, 120, 180 minutes
Pupillary Light Reflex (PLR) Amplitude
The changes that occur in PLR Amplitude as a response to an analgesic intervention will be investigated. The differences are calculated by comparing the parameters from before the intervention to after the intervention.
Measured: 0, 15, 30, 45, 60, 90, 120, 180 minutes
Pupillary Light Reflex (PLR) Recovery Time
The changes that occur in PLR Recovery Time as a response to an analgesic intervention will be investigated. The differences are calculated by comparing the parameters from before the intervention to after the intervention.
Measured: 0, 15, 30, 45, 60, 90, 120, 180 minutes
Pupillary Reflex Dilation (PRD) Amplitude
The changes that occur in PRD amplitude as a response to an analgesic intervention will be investigated. The differences are calculated by comparing the parameters from before the intervention to after the intervention.
Measured: 0, 15, 30, 45, 60, 90, 120, 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start29 Oct 2018
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Julia Finkel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Julia Finkel, Children's National Research Institute
- Investigators
- Julia C Finkel, MD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794362
- Sponsor's protocol ID
- 9586
- Status last verified
- Apr 2026
- First submitted
- 31 Oct 2018
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Method to Objectively Measure Analgesic Interventions: A Pilot Study
- ClinicalTrials.gov ID
- NCT03794362
- Acronym / sponsor ID
- 9586
- Conditions
- Pain
- Keywords
- analgesia, pain, nociception, pupillometry, analgesic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Julia FinkelUniversity, hospital or other
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Jan 2019 (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.
It is generally recognized that pain assessment and management especially in newborns, children and other nonverbal populations is an unmet need. According to the American Medical Association, "the pediatric population is at risk of inadequate pain management, with age-related factors affecting pain management in children. Children are often given minimal or no analgesia for procedures that would routinely be treated aggressively in adults. Although much is now known about pain management in children, it has not been widely or effectively translated into routine clinical practice". These two factors combine to emphasize the necessity for an objective tool to quantify pain and monitor the effectiveness of analgesia, especially during treatments. Further, it is reported that many patients require a combination of treatments, and it is often necessary to test a variety of treatments before the personal match for treatment is found. The method in place to change the care on a subjective basis is difficult, time consuming, and not easily individualized. This pilot study is part of an ongoing effort to develop a method to objectively assess response to specific analgesic interventions. It specifically aims to discern the impact of analgesic interventions on sensory nerve fiber sensitivity in a diverse patient population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Local Anesthetics | – | –Lidocaine |
| N-methyl-D-aspartate Antagonists | – | –Ketamine |
| SNRIs | – | –Duloxetine |
| Alpha-2 adrenergic agonists | – | –Dexmedetomidine |
| Oral Analgesics | – | –NSAIDs, acetaminophen |
| Non-pharmacologic interventions | – | –Acupuncture |
Who may qualify
- Ages
- 7 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients who are receiving pharmacological or non-pharmacological analgesic interventions as part of their regularly occurring clinical treatment.
Key inclusion criteria (3 listed)
- The subject is 7 to 21 years of age
- The subject is receiving an analgesic intervention in the Children's National Medical Center Pain Clinic
- The subject is willing and able to provide written informed assent/parental consent to the study participation.
Key exclusion criteria (3 listed)
- Eye pathology precluding pupillometry
- Patients who are actively using opioids (history of use acceptable). Rationale: opioids constrict the pupil, and therefore concomitant opioid use would bias our results.
- Subjects who are or may be pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pupillary Reflex Dilation (PRD) Area under Curve (AUC)
Time frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes
The changes that occur in PRD AUC as a response to an analgesic intervention will be investigated. The differences are calculated by comparing the parameters from before the intervention to after the intervention.
4 secondary outcomes
Pupillary Light Reflex (PLR) Latency
Time frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes
Pupillary Light Reflex (PLR) Amplitude
Time frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes
Pupillary Light Reflex (PLR) Recovery Time
Time frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes
Pupillary Reflex Dilation (PRD) Amplitude
Time frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes
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 7 Apr 2026.
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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.
Julia C Finkel, MD principal investigator
Children's National Research Institute
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 Pain, run by Julia Finkel 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 3 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 7 Apr 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 C Finkel, MD (2024764867, jfinkel@childrensnational.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pupillary Reflex Dilation (PRD) Area under Curve (AUC) (time frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2026.