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RECRUITING
NCT02044497
PHASE4

Population Pharmacokinetics and Pharmacogenomics of Oral Oxycodone in Pediatric Surgical Patients

Sponsor: Boston Children's Hospital

View on ClinicalTrials.gov

Summary

Oxycodone is an oral opioid analgesic that is most commonly prescribed for the management of pain in post-operative patients at Boston Children's Hospital. Oxycodone has been widely used in adults and children to relieve post-operative pain. However, its pharmacokinetics (what it does in the body) and pharmacodynamics (how it works) have not been well established in children. Some children, because of their specific genetic make-up, may metabolize the drug more quickly and therefore may be at risk for more side effects in the commonly prescribed dose. We would like to find out more about how this drug is absorbed, metabolized and excreted in children. In order to study these aspects, we would like to give oxycodone to surgical patients at Boston Children's Hospital then measure its metabolic activity and also perform a genetic analysis. The genetic testing is specifically to analyze the following genotypes only: cytochrome P450 2D6 (CYP2D6) and cytochrome P450 3A4 (CYP3A4), which represent the differences in cytochrome P450 metabolism of oxycodone.

Key Details

Gender

All

Age Range

Any - 6 Years

Study Type

INTERVENTIONAL

Enrollment

68

Start Date

2014-05

Completion Date

2026-12

Last Updated

2025-02-14

Healthy Volunteers

No

Interventions

DRUG

oral oxycodone

Locations (1)

Boston Children Hospital

Boston, Massachusetts, United States