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NCT03054831 · ClinicalTrials.gov registry record · Phase 4
The Effect of General Anesthesia on Pharmacokinetics of Oxycodone in Pediatric
A Phase 4 study of Liquid Oxycodone, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT03054831 is a Phase 4 study of Liquid Oxycodone that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 40 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03054831, a Phase 4 study of Liquid Oxycodone, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG liquid oxycodone
Study Locations (1)
Massachusetts
- Boston Children Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2019-07-08 |
| Est. Completion | 2026-12 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03054831
The ClinicalTrials.gov registry entry for NCT03054831 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Liquid Oxycodone appearing as the primary indexed condition, and to 1 intervention - of which liquid oxycodone is the first listed.
NCT03054831 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03054831 about?
NCT03054831 is a clinical study titled "The Effect of General Anesthesia on Pharmacokinetics of Oxycodone in Pediatric". 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) a...
What is the current status of trial NCT03054831?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2019-07-08. Estimated completion is 2026-12.
What conditions does trial NCT03054831 study?
This clinical trial studies the following conditions: Liquid Oxycodone.
What interventions are being tested in trial NCT03054831?
The interventions under investigation include: liquid oxycodone (DRUG).
Who is sponsoring clinical trial NCT03054831?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03054831 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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