Anesthetics and Analgesics in Children

Chi Dang Hornik551 enrolled

Overview

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

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

551

Conditions

Anesthesia Pain

Interventions

Ketorolac TromethamineDRUG

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

HydromorphoneDRUG

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

KetamineDRUG

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

Eligibility

Sex: ALLMin age: 0 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (13)

Lucile Packard Children's Hospital

Stanford, California, United States

RECRUITING

Children's Hospital Colorado

Aurora, Colorado, United States

Outcomes

Primary Outcomes

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)