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.
Measuring Analgesic Interventions
Brief 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 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
| Study type: | OBSERVATIONAL |
|---|---|
| Status: | Recruiting |
| Study results: | No Results Available |
| Age: | 7 Years to 21 Years |
| Enrollment: | 120 (ESTIMATED) |
| Funded by: | Other |
| Time Perspective: | Prospective |
| Observational Model: | Cohort |
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Clinical Trial Dates
| Start date: | Oct 29, 2018 | ACTUAL |
|---|---|---|
| Primary Completion: | Sep 01, 2023 | ESTIMATED |
| Completion Date: | Dec 01, 2023 | ESTIMATED |
| Study First Posted: | Jan 07, 2019 | ACTUAL |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Jan 31, 2023 |
Sponsors / Collaborators
Lead Sponsor:
N/A
Responsible Party:
N/A
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 7 |
| Maximum Age: | 21 |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
1. The subject is 7 to 21 years of age
2. The subject is receiving an analgesic intervention in the Children's National Medical Center Pain Clinic
3. The subject is willing and able to provide written informed assent/parental consent to the study participation.
Exclusion Criteria:
1. Eye pathology precluding pupillometry
2. Patients who are actively using opioids (history of use acceptable). Rationale: opioids constrict the pupil, and therefore concomitant opioid use would bias our results.
3. Subjects who are or may be pregnant
1. The subject is 7 to 21 years of age
2. The subject is receiving an analgesic intervention in the Children's National Medical Center Pain Clinic
3. The subject is willing and able to provide written informed assent/parental consent to the study participation.
Exclusion Criteria:
1. Eye pathology precluding pupillometry
2. Patients who are actively using opioids (history of use acceptable). Rationale: opioids constrict the pupil, and therefore concomitant opioid use would bias our results.
3. Subjects who are or may be pregnant
This clinical trial is recruiting
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Primary Outcomes
Secondary Outcomes
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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.
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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.
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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.
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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.
More Details
| NCT Number: | NCT03794362 |
|---|---|
| Other IDs: | 9586 |
| Study URL: | https://clinicaltrials.gov/study/NCT03794362 |
Last updated: Sep 29, 2023