Clinical trial NCT03427736: Anesthetics and Analgesics in Children
Official title: Pharmacokinetics of Anesthetics and Analgesics in Children and Adolescent
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anesthesia
Pain
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: The Emmes Company, LLC
First posted: 2018-02-09
Enrollment: 460
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 60 participants will be enrolled to each of the study drug of interests (DOI) cohorts. Participants who satisfy eligibility criteria and are receiving one or more DOIs per standard of care will be consented into the study and assigned to the corresponding DOI cohort. DOI cohort assignments will be at the discretion of the treating physician based on the DOIs that are administered per standard of care. Participants will be selected from a variety of centers including but not limited to trauma and intensive care units. Participants will not be randomized. Participants may count towards 1 or more DOIs within the same 90-day period.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Clearance (CL) or apparent oral clearance (CL/F)
timeFrame: up to 48 hours post dose
measure: Volume of distribution (V) or apparent oral volume of distribution (V/F)
timeFrame: up to 48 hours post dose
measure: Elimination rate constant (ke)
timeFrame: up to 48 hrs post dose
measure: Half-life (t1/2)
timeFrame: up to 48 hrs post dose
measure: Absorption rate constant (ka)
timeFrame: up to 48 hrs post dose
measure: Area under the curve (AUC)
timeFrame: up to 48 hrs post dose
measure: Maximum concentration (CMAX)
timeFrame: up to 48 hrs post dose
measure: Time to achieve maximum concentration (TMAX)
timeFrame: up to 48 hrs post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Lucile Packard Children's Hospital
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Wilmington
country: United States
facility: Alfred I. DuPont Hospital for Children
state: Delaware
city: Chicago
country: United States
facility: Ann and Robert H. Lurie Childrens Hospital of Chicago
state: Illinois
city: Saint Louis
country: United States
facility: Cardinal Glennon Children's Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Austin
country: United States
facility: Dell Children's Medical Center of Texas
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Montreal
country: Canada
facility: Hospital Sainte-Justine
state: Quebec
Study officials:
affiliation: Duke Clinical Research Institute
name: Kanecia Zimmerman
role: PRINCIPAL_INVESTIGATOR
References: