Active — Not RecruitingNot Applicable

Developing a Method to Objectively Measure Opioid Analgesia

United States40 participantsStarted 2018-07-01

Plain-language summary

Inappropriate prescribing is the fundamental upstream driver of the opioid epidemic. Objective measures to determine the appropriateness of an opioid intervention, provide monitoring of the therapy for adequacy of dose and detection of tolerance or hyperalgesia would eliminate the subjective nature of opioid mediated pain management and obviate iatrogenic facilitation of opioid abuse. The present study is designed to objectively determine whether our device can pain type and determine analgesic efficacy thereby optimizing treatment selection and opioid management.

Who can participate

Age range7 Years – 21 Years

SexALL

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Inclusion criteria

✓. The subject is 7 to 21 years of age
✓. The subject is receiving an opioid via bolus or a patient controlled analgesia (PCA) apparatus as part of treatment or fentanyl infusion in the pediatric intensive care unit (PICU) (generally postoperative patients).
✓. The subject is willing and able to provide written informed assent/parental consent to study participation

Exclusion criteria

✕. Eye pathology precluding pupillometry
✕. For patients in the PICU, patients who are hemodynamically unstable

What they're measuring

Changes in Pupillary Dilation Reflex AUC

Timeframe: 0, 15, 30, 45, 60, 90, 120, 180 minutes

Trial details

NCT IDNCT03605966

SponsorJulia Finkel

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-09-01

View on ClinicalTrials.gov More Analgesics, Antipyretics and Anti-Inflammatory Drugs Causing Adverse Effects in Therapeutic Use trials