Anesthetics and Analgesics in Children

Recruiting

• Conditions: Anesthesia; Pain
• Interventions: Drug: Ketorolac Tromethamine; Drug: Hydromorphone; Drug: Ketamine; Drug: Oxycodone; Drug: Morphine

• Registration Number: NCT03427736
• Lead Sponsor: Kanecia Obie Zimmerman

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 Timeline

• Study First Submitted: 2018-02-02
• Study First Submitted QC: 2018-02-08
• Study First Posted: 2018-02-09
• Study Start: 2018-12-13
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-23
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 460

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Drug of Interest	Ketorolac Tromethamine	Individuals receiving anesthetics or analgesics per standard of care
Drug of Interest	Oxycodone	Individuals receiving anesthetics or analgesics per standard of care
Drug of Interest	Hydromorphone	Individuals receiving anesthetics or analgesics per standard of care
Drug of Interest	Ketamine	Individuals receiving anesthetics or analgesics per standard of care
Drug of Interest	Morphine	Individuals receiving anesthetics or analgesics per standard of care

Primary Outcome Measures

Name	Time	Method
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
Time to achieve maximum concentration (TMAX)	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

Trial Locations

Locations (13)

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Ann and Robert H. Lurie Childrens Hospital of Chicago; 🇺🇸 Chicago, Illinois, 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, United States

Dell Children's Medical Center of Texas; 🇺🇸 Austin, Texas, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Cardinal Glennon Children's Hospital; 🇺🇸 Saint Louis, Missouri, United States

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada

Hospital Sainte-Justine; 🇨🇦 Montreal, Quebec, Canada

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States