Anesthetics and Analgesics in Children (ANA01)

Pharmacokinetics of Anesthetics and Analgesics in Children and Adolescent

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

Study Overview

• Status: Recruiting
• Conditions: Pain; Anesthesia
• Intervention / Treatment: Drug: Ketorolac Tromethamine; Drug: Hydromorphone; Drug: Ketamine; Drug: Oxycodone; Drug: Morphine

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Cheryl Alderman; Phone Number: 919-668-8349; Email: cheryl.alderman@duke.edu
• Study Contact Backup: Name: Kady-Ann Steen-Burrell, PhD; Phone Number: 919-530-9711; Email: kady.ann.steen.burrell@duke.edu

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • Recruiting
      • The Hospital for Sick Children
      • Contact: Yaron Finkelstein; Phone Number: 1-416-813-5317; Email: yaron.finkelstein@sickkids.ca
      • Contact: Maggie Rumantir; Phone Number: 1-416-813-7654; Email: maggie.rumantir@sickkids.ca
  • Quebec
    • Montreal, Quebec, Canada, T3T 1C5
      • Active, not recruiting
      • Hospital Sainte-Justine
• United States
  • California
    • Stanford, California, United States, 94305
      • Active, not recruiting
      • Lucile Packard Children's Hospital
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Terminated
      • Children's Hospital Colorado
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • Active, not recruiting
      • Alfred I. DuPont Hospital for Children
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Ann and Robert H. Lurie Childrens Hospital of Chicago
      • Contact: Richa Mehta; Phone Number: 1-312-227-4448; Email: rmehta@luriechildrens.org
      • Contact: Amy Fang, MD; Phone Number: 1-312-227-4448; Email: zafang@luriechildrens.org
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Active, not recruiting
      • Washington University School of Medicine
    • St Louis, Missouri, United States, 63104
      • Active, not recruiting
      • Cardinal Glennon Children's Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27701
      • Recruiting
      • Duke University Medical Center
      • Contact: Chi Hornik; Phone Number: 919.970.6680; Email: chi.dang@duke.edu
      • Contact: Melissa Harward; Phone Number: (919) 668-3910; Email: Melissa.Harward@duke.edu
  • Oregon
    • Portland, Oregon, United States, 97239
      • Active, not recruiting
      • Oregon Health and Science University
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Contact: John Costello, MD; Phone Number: 843-792-9570; Email: costello@musc.edu
      • Contact: Mary Freeman; Phone Number: 843-792-5762; Email: freemanme@musc.edu
  • Texas
    • Austin, Texas, United States, 78723
      • Withdrawn
      • Dell Children's Medical Center of Texas
    • Houston, Texas, United States, 77030
      • Withdrawn
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 17 years (Child)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Drug of Interest; Individuals receiving anesthetics or analgesics per standard of care

Drug: Ketorolac Tromethamine; IV ketorolac will be given per standard of care, not prescribed for this study; Other Names: Toradol; Drug: Hydromorphone; IV Hydromorphone will be given per standard of care, not prescribed for this study; Other Names: Dilaudid; Hydromorphone hydrochloride; Drug: Ketamine; IV Ketamine will be given per standard of care, not prescribed for this study; Other Names: Ketamine Hydrochloride; Drug: Oxycodone; PO Oxycodone(solution or tablet) will be given per standard of care, not prescribed for this study; Other Names: Oxycodone Hydrochloride; Drug: Morphine; IV Morphine will be given per standard of care, not prescribed for this study; Other Names: Morphine Sulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Chi Dang Hornik
• Collaborators: The Emmes Company, LLC
• Investigators: Principal Investigator: Chi Hornik, PharmD, Duke Clinical Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2018
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): September 9, 2027

Study Registration Dates

• First Submitted: February 2, 2018
• First Submitted That Met QC Criteria: February 8, 2018
• First Posted (Actual): February 9, 2018

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Indomethacin; Indoles; Heterocyclic Compounds, 4 or More Rings; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Morphine Derivatives; Codeine; Morphine; Ketamine; Hydromorphone; Ketorolac Tromethamine; Oxycodone
• Other Study ID Numbers: Pro00088893

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data collected is uploaded into the National Institute of Health Data Repository (DASH) at the end of the study (de-identified).
• IPD Sharing Time Frame: Data will be uploaded to the repository within 2 years of study completion. It will be maintained in the repository indefinitely.

IPD Sharing 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No