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Clinical Trial Summary

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


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03427736
Study type Observational
Source Duke University
Contact Cheryl Alderman
Phone 919-668-8349
Email cheryl.alderman@duke.edu
Status Not yet recruiting
Phase N/A
Start date May 2018
Completion date September 2020

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