Anesthetics and Analgesics in Children

Purpose

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

Conditions

  • Anesthesia
  • Pain

Eligibility

Eligible Ages
Between 0 Years and 17 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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
  • Drug: Ketamine
    IV Ketamine will be given per standard of care, not prescribed for this study
    Other names:
    • Ketamine Hydrochloride
  • Drug: Oxycodone
    PO Oxycodone(solution or tablet) will be given per standard of care, not prescribed for this study
    Other names:
    • Oxycodone Hydrochloride
  • Drug: Morphine
    IV Morphine will be given per standard of care, not prescribed for this study
    Other names:
    • Morphine Sulfate

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Kanecia Obie Zimmerman

Study Contact

Christie Milleson
919-668-6055
christie.milleson@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). 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).