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Clinical Trials/NCT03794362
NCT03794362
Recruiting
N/A

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

Julia Finkel1 site in 1 country120 target enrollmentOctober 29, 2018
ConditionsPain

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pain
Sponsor
Julia Finkel
Enrollment
120
Locations
1
Primary Endpoint
Pupillary Reflex Dilation (PRD) Area under Curve (AUC)
Status
Recruiting
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 29, 2018
End Date
December 1, 2025
Last Updated
9 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Julia Finkel
Responsible Party
Sponsor Investigator
Principal Investigator

Julia Finkel

Principal Investigator

Children's National Research Institute

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Pupillary Light Reflex (PLR) Recovery Time(0, 15, 30, 45, 60, 90, 120, 180 minutes)
  • Pupillary Reflex Dilation (PRD) Amplitude(0, 15, 30, 45, 60, 90, 120, 180 minutes)
  • Pupillary Light Reflex (PLR) Latency(0, 15, 30, 45, 60, 90, 120, 180 minutes)
  • Pupillary Light Reflex (PLR) Amplitude(0, 15, 30, 45, 60, 90, 120, 180 minutes)

Study Sites (1)

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