Measuring Analgesic Interventions

Study Overview
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Brief Summary
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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.

Official Title
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Developing a Method to Objectively Measure Analgesic Interventions: A Pilot Study

Conditions
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Pain

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Local Anesthetics<br>Lidocaine | |
| N-methyl-D-aspartate Antagonists<br>Ketamine | |
| SNRIs<br>Duloxetine | |
| Alpha-2 adrenergic agonists<br>Dexmedetomidine | |
| Oral Analgesics<br>NSAIDs, acetaminophen | |
| Non-pharmacologic interventions<br>Acupuncture | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0, 15, 30, 45, 60, 90, 120, 180 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 0, 15, 30, 45, 60, 90, 120, 180 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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analgesia, pain, nociception, pupillometry, analgesic