Measuring Analgesic Interventions

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

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 Overview

• Status: Recruiting
• Conditions: Pain

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Julia C Finkel, MD; Phone Number: 2024764867; Email: jfinkel@childrensnational.org

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Recruiting
      • Children's National Health System
      • Contact: Julia C Finkel, MD; Email: jfinkel@cnmc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 21 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
Local Anesthetics; Lidocaine
N-methyl-D-aspartate Antagonists; Ketamine
SNRIs; Duloxetine
Alpha-2 adrenergic agonists; Dexmedetomidine
Oral Analgesics; NSAIDs, acetaminophen
Non-pharmacologic interventions; Acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Julia Finkel

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 29, 2018
• Primary Completion (ANTICIPATED): September 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: October 31, 2018
• First Submitted That Met QC Criteria: January 3, 2019
• First Posted (ACTUAL): January 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2023
• Last Update Submitted That Met QC Criteria: January 31, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: analgesic; pain; analgesia; pupillometry; nociception
• Other Study ID Numbers: 9586

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No