Summary

for people ages 2-17 (full criteria)
at San Francisco, California and other locations
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 (hydromorphone) and to put people to sleep for surgery (ketamine). 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 will complete questionnaires about the study participant. Parents will continue to complete those same questionnaires for up to 12 months after the participant was first given the drug.

Keywords

Anesthesia Pain Anesthetics Ketamine Analgesics Hydromorphone Drug of Interest

Eligibility

You can join if…

Open to people ages 2-17

  • 2 years to < 18 years at the time of enrollment
  • Parent is able to understand the consent process and provides informed consent/HIPAA
  • Participant provides assent and as required by the institutional review board
  • Receiving one or more drugs of interest (DOI) per local standard of care meeting DOI-specific inclusion criteria

You CAN'T join if...

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

Locations

  • University of California San Francisco 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
Start Date
Completion Date
(estimated)
Sponsor
Christoph P Hornik, MD MPH
ID
NCT03427736
Study Type
Observational
Last Updated