Anesthetics and Analgesics in Children

Pain Clinical Trial

— ANA01  

Official title:

Pharmacokinetics of Anesthetics and Analgesics in Children and Adolescent

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03427736
• Other study ID #: Pro00088893
• Status: Recruiting
• Start date: December 13, 2018
• Est. completion date: June 30, 2025

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: Christie Milleson
• Phone: 919-668-6055
• Email: christie.milleson[@]duke.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 460
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Pain

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Canada	Hospital Sainte-Justine	Montreal	Quebec
Canada	The Hospital for Sick Children	Toronto	Ontario
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Dell Children's Medical Center of Texas	Austin	Texas
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Ann and Robert H. Lurie Childrens Hospital of Chicago	Chicago	Illinois
United States	Duke University Medical Center	Durham	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	Oregon Health and Science University	Portland	Oregon
United States	Cardinal Glennon Children's Hospital	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Lucile Packard Children's Hospital	Stanford	California
United States	Alfred I. DuPont Hospital for Children	Wilmington	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Kanecia Obie Zimmerman	The Emmes Company, LLC

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clearance (CL) or apparent oral clearance (CL/F)		up to 48 hours post dose
Primary	Volume of distribution (V) or apparent oral volume of distribution (V/F)		up to 48 hours post dose
Primary	Elimination rate constant (ke)		up to 48 hrs post dose
Primary	Half-life (t1/2)		up to 48 hrs post dose
Primary	Absorption rate constant (ka)		up to 48 hrs post dose
Primary	Area under the curve (AUC)		up to 48 hrs post dose
Primary	Maximum concentration (CMAX)		up to 48 hrs post dose
Primary	Time to achieve maximum concentration (TMAX)		up to 48 hrs post dose