Anesthetics and Analgesics in Children (ANA01)

Kanecia Obie Zimmerman

Status: Enrolling

Conditions: Pain; Anesthesia

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03427736

Pro00088893

Details and patient eligibility

About

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

Full 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).

Enrollment: 460 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

460 participants in 1 patient group

Drug of Interest

Description:

Individuals receiving anesthetics or analgesics per standard of care

Treatment:

Drug: Hydromorphone

Drug: Oxycodone

Drug: Morphine

Drug: Ketamine

Drug: Ketorolac Tromethamine