Anesthesia, Pain
Conditions
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).
Interventions
DRUGKetorolac Tromethamine
IV ketorolac will be given per standard of care, not prescribed for this study
DRUGHydromorphone
IV Hydromorphone will be given per standard of care, not prescribed for this study
DRUGKetamine
IV Ketamine will be given per standard of care, not prescribed for this study
DRUGOxycodone
PO Oxycodone(solution or tablet) will be given per standard of care, not prescribed for this study
DRUGMorphine
IV Morphine will be given per standard of care, not prescribed for this study
Sponsors
Chi Dang Hornik
The Emmes Company, LLC
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to 17 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clearance (CL) or apparent oral clearance (CL/F) | up to 48 hours post dose |
| Volume of distribution (V) or apparent oral volume of distribution (V/F) | up to 48 hours post dose |
| Elimination rate constant (ke) | up to 48 hrs post dose |
| Half-life (t1/2) | up to 48 hrs post dose |
| Absorption rate constant (ka) | up to 48 hrs post dose |
| Area under the curve (AUC) | up to 48 hrs post dose |
| Maximum concentration (CMAX) | up to 48 hrs post dose |
| Time to achieve maximum concentration (TMAX) | up to 48 hrs post dose |
Countries
Canada, United States
Contacts
CONTACTKady-Ann Steen-Burrell, PhD
CONTACTCheryl Alderman
PRINCIPAL_INVESTIGATORChi Hornik, PharmD
Duke Clinical Research Institute
Outcome results
None listed