Measuring Pain Relief in Children Using Eye Responses
Developing a Method to Objectively Measure Opioid Analgesia: A Pilot Study
This study is testing a new way to measure pain relief in children aged 7 to 21 by looking at how their pupils change when they are given opioid medications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 7 Years to 21 Years |
| Sex | All |
| Sponsor | Children's National Research Institute Academic / other |
| Locations | 1 site (Washington, District of Columbia) |
| Trial ID | NCT03605966 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop an objective method for assessing opioid analgesia in pediatric patients by utilizing pupillometry, which measures changes in pupil size in response to pain. The study addresses the critical issue of inadequate pain management in children, particularly those undergoing procedures, by creating algorithms that can detect pain types and evaluate the effectiveness of opioid treatments. By focusing on children aged 7 to 21 who are receiving opioids, the study seeks to eliminate the subjective nature of pain assessment and improve opioid management practices.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 7 to 21 who are receiving opioids for pain management in a clinical setting.
Not a fit: Patients with eye conditions that prevent pupillometry or those who are hemodynamically unstable in the pediatric intensive care unit may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective pain management strategies for children, reducing the risk of opioid misuse and improving overall patient care.
How similar studies have performed: While attempts have been made to objectively quantify pain, this specific approach using pupillometry in pediatric populations is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The subject is 7 to 21 years of age 2. 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). 3. The subject is willing and able to provide written informed assent/parental consent to study participation Exclusion Criteria: 1. Eye pathology precluding pupillometry 2. For patients in the PICU, patients who are hemodynamically unstable
Where this trial is running
Washington, District of Columbia
- Children's National Health System — Washington, District of Columbia, United States (Recruiting)
Study contacts
- Principal investigator: Julia C Finkel, MD — Children's National Health System
- Study coordinator: Julia C Finkel, MD
- Email: jcfinkel@childrensnational.org
- Phone: 2024764867
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.