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NCT Number: NCT03427736

Anesthetics and Analgesics in Children

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

Recruiting

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Key information

Conditions

Anesthesia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hospital for Sick Children, Toronto, Ontario, Canada

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketorolac Tromethamine

Drug

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

Other names: Toradol

Hydromorphone

Drug

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

Other names: Hydromorphone hydrochloride, Dilaudid

ketamine

Drug

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

Other names: Ketamine Hydrochloride

Oxycodone

Drug

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

Other names: Oxycodone Hydrochloride

Morphine

Drug

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

Other names: Morphine Sulfate

Primary outcomes

  1. Clearance (CL) or apparent oral clearance (CL/F)

    Time frame: up to 48 hours post dose

  2. Volume of distribution (V) or apparent oral volume of distribution (V/F)

    Time frame: up to 48 hours post dose

  3. Elimination rate constant (ke)

    Time frame: up to 48 hrs post dose

  4. Half-life (t1/2)

    Time frame: up to 48 hrs post dose

  5. Absorption rate constant (ka)

    Time frame: up to 48 hrs post dose

  6. Area under the curve (AUC)

    Time frame: up to 48 hrs post dose

  7. Maximum concentration (CMAX)

    Time frame: up to 48 hrs post dose

  8. Time to achieve maximum concentration (TMAX)

    Time frame: up to 48 hrs post dose

Study contacts

Contact information is provided by the study sponsor or research team.

Cheryl Alderman

CONTACT

[email protected]

919-668-8349

Kady-Ann Steen-Burrell, PhD

CONTACT

[email protected]

919-530-9711

Sponsors and collaborators

Lead sponsor

Chi Dang Hornik

Other

Collaborators

  • The Emmes Company, LLC

Registry information

Official study title

Pharmacokinetics of Anesthetics and Analgesics in Children and Adolescent

Acronym: ANA01

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Feb 9, 2018
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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