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ANA01: Anesthetics and Analgesics in Children

Sponsor
Kanecia Obie Zimmerman (Other)
Overall Status
Recruiting
CT.gov ID
NCT03427736
Collaborator
The Emmes Company, LLC (Industry)
460
Enrollment
15
Locations
60.6
Anticipated Duration (Months)
30.7
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

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). Parents may be asked to complete questionnaires about the study participant. Parents may be asked to complete those same questionnaires for up to 12 months after the participant was first given the drug, depending on the drug their child received. 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 Design

Study Type:
Observational
Anticipated Enrollment :
460 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Pharmacokinetics of Anesthetics and Analgesics in Children and Adolescent
Actual Study Start Date :
Dec 13, 2018
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm 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:
  • Hydromorphone hydrochloride
  • Dilaudid

    • 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clearance (CL) or apparent oral clearance (CL/F) [up to 48 hours post dose]

    2. Volume of distribution (V) or apparent oral volume of distribution (V/F) [up to 48 hours post dose]

    3. Elimination rate constant (ke) [up to 48 hrs post dose]

    4. Half-life (t1/2) [up to 48 hrs post dose]

    5. Absorption rate constant (ka) [up to 48 hrs post dose]

    6. Area under the curve (AUC) [up to 48 hrs post dose]

    7. Maximum concentration (CMAX) [up to 48 hrs post dose]

    8. Time to achieve maximum concentration (TMAX) [up to 48 hrs post dose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California San Francisco San Francisco California United States 94143
    2 Lucile Packard Children's Hospital Stanford California United States 94305
    3 Children's Hospital Colorado Aurora Colorado United States 80045
    4 Alfred I. DuPont Hospital for Children Wilmington Delaware United States 19803
    5 Cardinal Glennon Children's Hospital Saint Louis Missouri United States 63104
    6 Washington University School of Medicine Saint Louis Missouri United States 63110
    7 University of New Mexico, Health Sciences Center Albuquerque New Mexico United States 87131
    8 Duke University Medical Center Durham North Carolina United States 27701
    9 Oregon Health and Science University Portland Oregon United States 97239
    10 Medical University of South Carolina Charleston South Carolina United States 29425
    11 Vanderbilt University Nashville Tennessee United States 37232
    12 Baylor College of Medicine Houston Texas United States 77030
    13 University of Texas Health Science Center Houston Texas United States 77030
    14 The Hospital for Sick Children Toronto Ontario Canada M5G 1X8
    15 Hospital Sainte-Justine Montreal Quebec Canada T3T 1C5

    Sponsors and Collaborators

    • Kanecia Obie Zimmerman
    • The Emmes Company, LLC

    Investigators

    • Principal Investigator: Kanecia Zimmerman, Duke Clinical Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kanecia Obie Zimmerman, Assistant Professor of Pediatrics, Duke University
    ClinicalTrials.gov Identifier:
    NCT03427736
    Other Study ID Numbers:
    • Pro00088893
    First Posted:
    Feb 9, 2018
    Last Update Posted:
    Jun 9, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Ketorolac
    Ketorolac Tromethamine
    Ketamine
    Morphine
    Oxycodone
    Hydromorphone

    Study Results

    No Results Posted as of Jun 9, 2022