Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Local Anesthetics | Lidocaine | ||
| N-methyl-D-aspartate Antagonists | Ketamine | ||
| SNRIs | Duloxetine | ||
| Alpha-2 adrenergic agonists | Dexmedetomidine | ||
| Oral Analgesics | NSAIDs, acetaminophen | ||
| Non-pharmacologic interventions | Acupuncture |
Not provided
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients who are receiving pharmacological or non-pharmacological analgesic interventions as part of their regularly occurring clinical treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julia C Finkel, MD | Contact | 2024764867 | jfinkel@childrensnational.org |
| Name | Affiliation | Role |
|---|---|---|
| Julia C Finkel, MD | Children's National Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's National Health System | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |