NCT03427736

Anesthetics and Analgesics in Children

Pharmacokinetics of Anesthetics and Analgesics in Children and Adolescent

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 460 (estimated)
• Sponsor: Chi Dang Hornik · Academic / Other
• Sex: All
• Age: 0 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Anesthesia
• Pain

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-12-13
• Primary completion: 2026-08-30
• Completion: 2026-09-09
• First posted: 2018-02-09
• Last updated: 2026-02-06

Locations

13 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study