Anesthetics and Analgesics in Children

NCT03427736 · tracked via the Priya Life Science Canada tracker

Sponsor

Chi Dang Hornik

Phase

Observational

Started

2018-12-13

Last updated

2026-08-05

Condition(s) studied

AnesthesiaPain

Investigational drug(s) / intervention(s)

Ketorolac Tromethamine →Hydromorphone →Ketamine →Oxycodone →Morphine →

Ketorolac Tromethamine: IV ketorolac will be given per standard of care, not prescribed for this study

Hydromorphone: IV Hydromorphone will be given per standard of care, not prescribed for this study

Ketamine: IV Ketamine will be given per standard of care, not prescribed for this study

Oxycodone: PO Oxycodone(solution or tablet) will be given per standard of care, not prescribed for this study

Morphine: IV Morphine will be given per standard of care, not prescribed for this study

Study summary

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

Eligibility

Sex

ALL

Min age

0 Years

Max age

17 Years

Healthy volunteers

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 outcome measure(s)

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

Trial sites (13)

Facility	City	Region	Status
Lucile Packard Children's Hospital	Stanford	California	Recruiting
Children's Hospital Colorado	Aurora	Colorado	Terminated
Alfred I. DuPont Hospital for Children	Wilmington	Delaware	Active Not Recruiting
Ann and Robert H. Lurie Childrens Hospital of Chicago	Chicago	Illinois	Recruiting
Cardinal Glennon Children's Hospital	St Louis	Missouri	Active Not Recruiting
Washington University School of Medicine	St Louis	Missouri	Active Not Recruiting
Duke University Medical Center	Durham	North Carolina	Recruiting
Oregon Health and Science University	Portland	Oregon	Active Not Recruiting
Medical University of South Carolina	Charleston	South Carolina	Recruiting
Dell Children's Medical Center of Texas	Austin	Texas	Withdrawn
Baylor College of Medicine	Houston	Texas	Withdrawn
The Hospital for Sick Children	Toronto	Ontario	Recruiting
Hospital Sainte-Justine	Montreal	Quebec	Active Not Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03427736 on ClinicalTrials.gov ↗ ← All trials in Canada