Purpose

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

Conditions

Eligibility

Eligible Ages
Between 2 Years and 17 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Study Design

Phase
Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Drug of Interest Individuals receiving anesthetics or analgesics per standard of care
  • Drug: Ketorolac Tromethamine
    IV ketorolac will be given per standard of care, not prescribed for this study
    Other names:
    • Toradol
  • Drug: Hydromorphone
    IV Hydromorphone will be given per standard of care, not prescribed for this study
    Other names:
    • Hydromorphone hydrochloride
    • Dilaudid

Recruiting Locations

University of Texas Health Science Center
Houston, Texas 77030
Contact:
Jon Meliones
713-500-5359
Jon.Meliones@uth.tmc.edu

More Details

NCT ID
NCT03427736
Status
Recruiting
Sponsor
Kanecia Zimmerman, MD MPH

Study Contact

Cheryl Alderman
919-668-8349
cheryl.alderman@duke.edu

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). 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. Examples of current and upcoming anesthetics and analgesics include, but are not limited to: hydromorphone (Dilaudid), ketorolac (Toradol), methadone and ketamine.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.