Anesthetics and Analgesics in Children

NCT03427736 | Recruiting DMC FDA Drug

• 1 other identifier: Pro00088893
• Study Type: observational
• Target: 500
• Locations: 2 countries
• Sites: 13

Brief Summary

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

Conditions

Anesthesia; Pain

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (1)

Drug of Interest

Individuals receiving anesthetics or analgesics per standard of care

Drug: Ketorolac Tromethamine; Drug: Hydromorphone; Drug: Ketamine; Drug: Oxycodone; Drug: Morphine

Interventions

Ketorolac Tromethamine DRUG

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

Also known as: Toradol

Drug of Interest

Hydromorphone DRUG

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

Also known as: Hydromorphone hydrochloride, Dilaudid

Drug of Interest

Ketamine DRUG

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

Also known as: Ketamine Hydrochloride

Drug of Interest

Oxycodone DRUG

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

Also known as: Oxycodone Hydrochloride

Drug of Interest

Morphine DRUG

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

Also known as: Morphine Sulfate

Drug of Interest

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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)
• Parent and/or participant (if applicable) is able to understand the consent process and provides informed consent and HIPAA Authorization (if applicable)
• Participant provides assent as required by the institutional review board (IRB) or research ethics board (REB)
• Receiving one or more drugs of interest (DOI) per local standard of care

You may not qualify if:

• Known pregnancy
• Extracorporeal life support (i.e., ECMO, dialysis, ventricular assist device)
• Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

Sponsors & Collaborators

• Chi Dang Hornik: lead
• The Emmes Company, LLC: collaborator

Study Sites (13)

Lucile Packard Children's Hospital

Stanford, California, 94305, United States

ACTIVE NOT RECRUITING

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

TERMINATED

Alfred I. DuPont Hospital for Children

Wilmington, Delaware, 19803, United States

ACTIVE NOT RECRUITING

Ann and Robert H. Lurie Childrens Hospital of Chicago

Chicago, Illinois, 60611, United States

RECRUITING

Cardinal Glennon Children's Hospital

St Louis, Missouri, 63104, United States

ACTIVE NOT RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

ACTIVE NOT RECRUITING

Duke University Medical Center

Durham, North Carolina, 27701, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

ACTIVE NOT RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Dell Children's Medical Center of Texas

Austin, Texas, 78723, United States

WITHDRAWN

Baylor College of Medicine

Houston, Texas, 77030, United States

WITHDRAWN

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

Hospital Sainte-Justine

Montreal, Quebec, T3T 1C5, Canada

ACTIVE NOT RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Left over specimens will be de-identified and sent to the NICHD biorepository at the end of the study. These specimens may be made available to other researchers. Future unspecified tests conducted may include genetic testing.

MeSH Terms

Conditions

Pain

Interventions

Ketorolac Tromethamine; Hydromorphone; Ketamine; Oxycodone; Morphine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Codeine

Study Officials

• Chi Hornik, PharmD

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kady-Ann Steen-Burrell, PhD

CONTACT

919-530-9711; kady.ann.steen.burrell@duke.edu

Cheryl Alderman

CONTACT

919-668-8349; cheryl.alderman@duke.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 9, 2018
• Study Start: December 13, 2018
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): September 9, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be uploaded to the repository within 2 years of study completion. It will be maintained in the repository indefinitely.
• Access Criteria: In order to have access, researchers have to complete a Data access request. NICHD will review the request and either approve or deny it. IRB approval must be obtained by the researcher to access the data. https://dash.nichd.nih.gov/Resource/DataRequestChecklist

Locations

US (11); CA (2)