Measuring Analgesic Interventions

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03794362
• Other study ID #: 9586
• Status: Recruiting
• Start date: October 29, 2018
• Est. completion date: December 2023

Study information

• Verified date: January 2023
• Source: Children's National Research Institute
• Contact: Julia C Finkel, MD
• Phone: 2024764867
• Email: jfinkel[@]childrensnational.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Locations

Country	Name	City	State
United States	Children's National Health System	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Julia Finkel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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