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NCT03427736Recruiting

Anesthetics and Analgesics in Children

Chi Dang Hornik

Start Date

12/13/2018

Completion Date

9/9/2027

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 is broken down in the body. Participants will be given these drugs as they are prescribed by their regular doctor. As part of the participant's standard of care, doctors will perform tests, ask questions, review medical information and measure vital signs (heart rate, blood pressure, etc). The researchers will collect information that doctors have already written in the medical records. The research study team will collect blood from participants at certain time points depending on when the participant was first given the drug (up to 5 samples over the course of 10 to 48 hours). Examples of current and upcoming anesthetics and analgesics include, but are not limited to: ketorolac (Toradol), ketamine (Ketalar), oxycodone (OxyContin), and morphine (Kadian, MS Contin).

Eligibility Criteria

Age Range: No minimum to 17 years

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

Interventions

DRUG

Ketorolac Tromethamine

DRUG

Hydromorphone

DRUG

Ketamine

DRUG

Oxycodone

DRUG

Morphine

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Conditions

AnesthesiaPain

Locations

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

St Louis, Missouri 63104

United States

Washington University School of Medicine

St 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

The Hospital for Sick Children

Toronto, Ontario M5G 1X8

Canada

Hospital Sainte-Justine

Montreal, Quebec T3T 1C5

Canada