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The Effect of General Anesthesia on Pharmacokinetics of Oxycodone in Pediatric

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Jun 2026 to Dec 2026
    • Study completion date: Dec 2026 to Dec 2027
    • Site details revised
    v16
  2. Re-verified, no change to tracked fieldsv15
  3. Primary completion date: Jun 2023 to Jun 2026
    • Study completion date: Dec 2023 to Dec 2026
    v14
  4. Primary completion date: Jun 2022 to Jun 2023
    • Study completion date: Jun 2022 to Dec 2023
    v13
  5. Primary and study completion dates: Jun 2021 to Jun 2022v12
Show 10 earlier versionsHide 10 earlier versions
  1. Primary and study completion dates: Jun 2020 to Jun 2021v11
  2. Start date changed from estimate of Jul 1, 2019 to Jul 8, 2019v10
  3. Primary and study completion dates: Jun 2019 to Jun 2020
    • Start date: May 1, 2019 to Jul 1, 2019
    v9
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Mar 2019 to May 1, 2019
    • Study sites: 0 to 1
    v8
  5. Start date: Jan 2019 to Mar 2019v7
  6. Start date: Oct 2018 to Jan 2019v6
  7. Start date: Jun 2018 to Oct 2018v5
  8. Start date: Mar 2018 to Jun 2018v4
  9. Start date: Dec 2017 to Mar 2018v3
  10. Start date: Jun 2017 to Dec 2017v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03054831
Lead Sponsor Boston Children's Hospital
Conditions
(from sponsor)		 Liquid Oxycodone
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov