Clinical trial NCT03794362: Measuring Analgesic Interventions
Official title: Developing a Method to Objectively Measure Analgesic Interventions: A Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pain
Keywords: analgesia
pain
nociception
pupillometry
analgesic
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2019-01-07
Enrollment: 120
Sex: ALL
Minimum age (years): 7
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are receiving pharmacological or non-pharmacological analgesic interventions as part of their regularly occurring clinical treatment.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pupillary Reflex Dilation (PRD) Area under Curve (AUC)
timeFrame: 0, 15, 30, 45, 60, 90, 120, 180 minutes
Secondary outcomes:
measure: Pupillary Light Reflex (PLR) Latency
timeFrame: 0, 15, 30, 45, 60, 90, 120, 180 minutes
measure: Pupillary Light Reflex (PLR) Amplitude
timeFrame: 0, 15, 30, 45, 60, 90, 120, 180 minutes
measure: Pupillary Light Reflex (PLR) Recovery Time
timeFrame: 0, 15, 30, 45, 60, 90, 120, 180 minutes
measure: Pupillary Reflex Dilation (PRD) Amplitude
timeFrame: 0, 15, 30, 45, 60, 90, 120, 180 minutes
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Health System
state: District of Columbia
Study officials:
affiliation: Children's National Health System
name: Julia C Finkel, MD
role: PRINCIPAL_INVESTIGATOR
References: