Pharmacokinetics of Anesthetics and Analgesics in Children and Adolescent
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 551
- Locations
- 18
- Primary Endpoint
- Elimination rate constant (ke)
Study Overview
Brief Summary
The purpose of this study is to characterize the pharmacokinetic (PK) and safety profile of anesthetics and analgesics in children and adolescents.
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).
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 0 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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)
- •Parent and/or participant (if applicable) is able to understand the consent process and provides informed consent and HIPAA Authorization (if applicable)
- •Participant provides assent as required by the institutional review board (IRB) or research ethics board (REB)
- •Receiving one or more drugs of interest (DOI) per local standard of care
- •Meeting DOI-specific inclusion criteria (See Appendices)
Exclusion Criteria
- •Known pregnancy
- •Extracorporeal life support (i.e., ECMO, dialysis, ventricular assist device)
- •Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Arms & Interventions
Drug of Interest
Individuals receiving anesthetics or analgesics per standard of care
Intervention: Ketorolac Tromethamine (Drug)
Drug of Interest
Individuals receiving anesthetics or analgesics per standard of care
Intervention: Hydromorphone (Drug)
Drug of Interest
Individuals receiving anesthetics or analgesics per standard of care
Intervention: Ketamine (Drug)
Drug of Interest
Individuals receiving anesthetics or analgesics per standard of care
Intervention: Oxycodone (Drug)
Drug of Interest
Individuals receiving anesthetics or analgesics per standard of care
Intervention: Morphine (Drug)
Outcomes
Primary Outcomes
Elimination rate constant (ke)
Time Frame: up to 48 hrs post dose
Absorption rate constant (ka)
Time Frame: up to 48 hrs post dose
Clearance (CL) or apparent oral clearance (CL/F)
Time Frame: up to 48 hours post dose
Volume of distribution (V) or apparent oral volume of distribution (V/F)
Time Frame: up to 48 hours post dose
Half-life (t1/2)
Time Frame: up to 48 hrs post dose
Time to achieve maximum concentration (TMAX)
Time Frame: up to 48 hrs post dose
Area under the curve (AUC)
Time Frame: up to 48 hrs post dose
Maximum concentration (CMAX)
Time Frame: up to 48 hrs post dose
Secondary Outcomes
No secondary outcomes reported
Investigators
Chi Dang Hornik
Associate Professor of Pediatrics
Duke University