Status:
RECRUITING
Anesthetics and Analgesics in Children
Lead Sponsor:
Kanecia Obie Zimmerman
Collaborating Sponsors:
The Emmes Company, LLC
Conditions:
Anesthesia
Pain
Eligibility:
All Genders
Up to 17 years
Brief Summary
The purpose of this study is to characterize the pharmacokinetic (PK) and safety profile of anesthetics and analgesics in children and adolescents.
Detailed Description
This is a research study to find out what the side effects are of certain drugs that are commonly used for pain and to put people to sleep for surgery. The researchers also want to know how the drug i...
Eligibility Criteria
Inclusion
- 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
- Meeting DOI-specific inclusion criteria (See Appendices)
Exclusion
- 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
Key Trial Info
Start Date :
December 13 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 9 2026
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT03427736
Start Date
December 13 2018
End Date
September 9 2026
Last Update
July 31 2025
Active Locations (13)
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1
Lucile Packard Children's Hospital
Stanford, California, United States, 94305
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
3
Alfred I. DuPont Hospital for Children
Wilmington, Delaware, United States, 19803
4
Ann and Robert H. Lurie Childrens Hospital of Chicago
Chicago, Illinois, United States, 60611