Understanding how anesthetics and pain medications affect children

Pharmacokinetics of Anesthetics and Analgesics in Children and Adolescent

This study looks at how different pain and anesthesia medications affect children and teenagers to see how safe they are and how the body processes them.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 0 Years to 17 Years
• Sex: All
• Sponsor: Duke University (Academic / other)
• Locations: 13 sites (Stanford, California and 12 other locations)
• Trial ID: NCT03427736 on ClinicalTrials.gov

What this trial studies

This observational study aims to characterize the pharmacokinetic and safety profiles of various anesthetics and analgesics used in children and adolescents. Participants will receive these medications as prescribed by their healthcare providers, and researchers will collect data from medical records, vital signs, and blood samples over a period of 10 to 48 hours. The study focuses on commonly used drugs such as ketorolac, ketamine, oxycodone, and morphine to assess their side effects and how they are metabolized in the body.

Who should consider this trial

Good fit: Ideal candidates are children and adolescents aged 0 to under 18 years who are prescribed one or more of the drugs being studied.

Not a fit: Patients who are pregnant or have conditions that make them unsuitable for the study will not benefit from this research.

Why it matters

Potential benefit: If successful, this study could enhance the safety and efficacy of pain management and anesthesia in pediatric patients.

How similar studies have performed: Other studies have explored the pharmacokinetics of anesthetics in children, indicating a growing body of evidence, though this specific approach may provide novel insights.

Eligibility criteria

Inclusion Criteria:

1. 0 to \<18 years of age at time of enrollment (must see applicable appendix for details as not all appendices enroll across the entire age range)
2. Parent and/or participant (if applicable) is able to understand the consent process and provides informed consent and HIPAA Authorization (if applicable)
3. Participant provides assent as required by the institutional review board (IRB) or research ethics board (REB)
4. Receiving one or more drugs of interest (DOI) per local standard of care
5. Meeting DOI-specific inclusion criteria (See Appendices)

Exclusion Criteria:

1. Known pregnancy
2. Extracorporeal life support (i.e., ECMO, dialysis, ventricular assist device)
3. Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

Where this trial is running

Stanford, California and 12 other locations

• Lucile Packard Children's Hospital — Stanford, California, United States (Active_not_recruiting)
• Children's Hospital Colorado — Aurora, Colorado, United States (Terminated)
• Alfred I. DuPont Hospital for Children — Wilmington, Delaware, United States (Active_not_recruiting)
• Ann and Robert H. Lurie Childrens Hospital of Chicago — Chicago, Illinois, United States (Recruiting)
• Cardinal Glennon Children's Hospital — St Louis, Missouri, United States (Active_not_recruiting)
• Washington University School of Medicine — St Louis, Missouri, United States (Active_not_recruiting)
• Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
• Oregon Health and Science University — Portland, Oregon, United States (Active_not_recruiting)
• Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
• Dell Children's Medical Center of Texas — Austin, Texas, United States (Withdrawn)
• Baylor College of Medicine — Houston, Texas, United States (Withdrawn)
• The Hospital for Sick Children — Toronto, Ontario, Canada (Recruiting)
• Hospital Sainte-Justine — Montreal, Quebec, Canada (Active_not_recruiting)

Study contacts

• Principal investigator: Chi Hornik, PharmD — Duke Clinical Research Institute
• Study coordinator: Kady-Ann Steen-Burrell, PhD

Conditions Anesthesia; Pain