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Recruiting NCT03427736

Anesthetics and Analgesics in Children

— Observational Anesthesia Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ketorolac Tromethamine, Hydromorphone, Ketamine, Oxycodone.
Who it may be relevant to
Registry conditions: Anesthesia, Pain. Basic parameters: 0 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Pharmacokinetics of Anesthetics and Analgesics in Children and Adolescent

Overview

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).

Interventions

  • Drug Ketorolac Tromethamine
    IV ketorolac will be given per standard of care, not prescribed for this study
  • Drug Hydromorphone
    IV Hydromorphone will be given per standard of care, not prescribed for this study
  • Drug Ketamine
    IV Ketamine will be given per standard of care, not prescribed for this study
  • Drug Oxycodone
    PO Oxycodone(solution or tablet) will be given per standard of care, not prescribed for this study
  • Drug Morphine
    IV Morphine will be given per standard of care, not prescribed for this study

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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)
  • 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
  • Meeting DOI-specific inclusion criteria (See Appendices)

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United States · 11 centers
  • Lucile Packard Children's Hospital — Stanford
  • Children's Hospital Colorado — Aurora
  • Alfred I. DuPont Hospital for Children — Wilmington
  • Ann and Robert H. Lurie Childrens Hospital of Chicago — Chicago
  • Cardinal Glennon Children's Hospital — St Louis
  • Washington University School of Medicine — St Louis
  • Duke University Medical Center — Durham
  • Oregon Health and Science University — Portland
  • … and 3 more centers
Canada · 2 centers
  • The Hospital for Sick Children — Toronto
  • Hospital Sainte-Justine — Montreal

Identifiers

NCT: NCT03427736 · Pro00088893

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗