RECRUITING

Anesthetics and Analgesics in Children

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Conditions

AnesthesiaPain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Pharmacokinetics of Anesthetics and Analgesics in Children and Adolescent

Quick Facts

Study Start:2018-12-13
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03427736

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Parent and/or participant (if applicable) is able to understand the consent process and provides informed consent and HIPAA Authorization (if applicable)
  3. 3. Participant provides assent as required by the institutional review board (IRB) or research ethics board (REB)
  4. 4. Receiving one or more drugs of interest (DOI) per local standard of care
  5. 5. Meeting DOI-specific inclusion criteria (See Appendices)
  1. 1. Known pregnancy
  2. 2. Extracorporeal life support (i.e., ECMO, dialysis, ventricular assist device)
  3. 3. Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

Contacts and Locations

Study Contact

Christie Milleson
CONTACT
919-668-6055
christie.milleson@duke.edu
Cheryl Alderman
CONTACT
919-668-8349
cheryl.alderman@duke.edu

Principal Investigator

Kanecia Zimmerman
PRINCIPAL_INVESTIGATOR
Duke Clinical Research Institute

Study Locations (Sites)

Lucile Packard Children's Hospital
Stanford, California, 94305
United States
Children's Hospital Colorado
Aurora, Colorado, 80045
United States
Alfred I. DuPont Hospital for Children
Wilmington, Delaware, 19803
United States
Ann and Robert H. Lurie Childrens Hospital of Chicago
Chicago, Illinois, 60611
United States
Cardinal Glennon Children's Hospital
Saint Louis, Missouri, 63104
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Duke University Medical Center
Durham, North Carolina, 27701
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Dell Children's Medical Center of Texas
Austin, Texas, 78723
United States
Baylor College of Medicine
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Kanecia Obie Zimmerman

  • Kanecia Zimmerman, PRINCIPAL_INVESTIGATOR, Duke Clinical Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-12-13
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2018-12-13
Study Completion Date2025-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Anesthesia
  • Pain