Measuring Analgesic Interventions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pain. Basic parameters: 7 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Developing a Method to Objectively Measure Analgesic Interventions: A Pilot Study
Overview
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.
Primary outcome measures
- Pupillary Reflex Dilation (PRD) Area under Curve (AUC) [Time frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes]
Secondary outcome measures (4)
- Pupillary Light Reflex (PLR) Latency [Time frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes]
- Pupillary Light Reflex (PLR) Amplitude [Time frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes]
- Pupillary Light Reflex (PLR) Recovery Time [Time frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes]
- Pupillary Reflex Dilation (PRD) Amplitude [Time frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Children's National Health System — Washington D.C.
Identifiers
NCT: NCT03794362 · 9586