Clinical Trial

The Effect of General Anesthesia on Pharmacokinetics of Oxycodone in Pediatric

Active, Not Recruiting Phase 4
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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. The investigators would like to find out more about how general anesthesia (GA) effects how this drug is absorbed, metabolized and excreted in children. In order to study these aspects, the investigators would like to give oxycodone to surgical patients (group one will receive oxycodone at the beginning of GA and group two will receive oxycodone at the end of GA) at Boston Children's Hospital then measure its metabolic activity and also perform a specific genetic analysis.
Protocol Amendment History 15 amendments
This ClinicalTrials.gov record has been amended 15 times since 2017-02-13; most recent amendment 2026-04-21.
Status change: Recruiting → Active, Not Recruiting 2026-04-21
Status change: Not Yet Recruiting → Recruiting 2019-04-16
Trial Details
NCT Number NCT03054831
Lead Sponsor Boston Children's Hospital
Conditions Liquid Oxycodone
Enrollment 40 participants
Start Date 2019-07-08
Primary Completion 2026-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-22