Summary

Eligibility
for people ages 0-17 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

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

Details

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). Parents may be asked to complete questionnaires about the study participant. Parents may be asked to complete those same questionnaires for up to 12 months after the participant was first given the drug, depending on the drug their child received. 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).

Keywords

Anesthesia, Pain, Ketorolac, Ketorolac Tromethamine, Ketamine, Morphine, Oxycodone, Hydromorphone, Drug of Interest

Eligibility

You can join if…

Open to people ages 0-17

  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)

You CAN'T join if...

  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

Locations

  • University of California San Francisco in progress, not accepting new patients
    San Francisco California 94143 United States
  • Lucile Packard Children's Hospital accepting new patients
    Stanford California 94305 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Kanecia Obie Zimmerman
ID
NCT03427736
Study Type
Observational
Participants
Expecting 460 study participants
Last Updated