RecruitingNCT03427736

Anesthetics and Analgesics in Children

Pharmacokinetics of Anesthetics and Analgesics in Children and Adolescent


Sponsor

Chi Dang Hornik

Enrollment

460 participants

Start Date

Dec 13, 2018

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this study is to characterize the pharmacokinetic (PK) and safety profile of anesthetics and analgesics in children and adolescents.


Eligibility

Min Age: 0 YearsMax Age: 17 Years

Inclusion Criteria4

  • 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)
  • Parent and/or participant (if applicable) is able to understand the consent process and provides informed consent and HIPAA Authorization (if applicable)
  • Participant provides assent as required by the institutional review board (IRB) or research ethics board (REB)
  • Receiving one or more drugs of interest (DOI) per local standard of care

Exclusion Criteria3

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

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Interventions

DRUGKetorolac Tromethamine

IV ketorolac will be given per standard of care, not prescribed for this study

DRUGHydromorphone

IV Hydromorphone will be given per standard of care, not prescribed for this study

DRUGKetamine

IV Ketamine will be given per standard of care, not prescribed for this study

DRUGOxycodone

PO Oxycodone(solution or tablet) will be given per standard of care, not prescribed for this study

DRUGMorphine

IV Morphine will be given per standard of care, not prescribed for this study


Locations(13)

Lucile Packard Children's Hospital

Stanford, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Alfred I. DuPont Hospital for Children

Wilmington, Delaware, United States

Ann and Robert H. Lurie Childrens Hospital of Chicago

Chicago, Illinois, United States

Cardinal Glennon Children's Hospital

St Louis, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Duke University Medical Center

Durham, North Carolina, United States

Oregon Health and Science University

Portland, Oregon, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Dell Children's Medical Center of Texas

Austin, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

The Hospital for Sick Children

Toronto, Ontario, Canada

Hospital Sainte-Justine

Montreal, Quebec, Canada

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NCT03427736


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