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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: Recruiting Phase 4 study of Liquid Oxycodone, sponsored by Boston Children's Hospital.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Plasma oxycodone levels, at 10 time points, will be used to determine the area under the curve(AUC)
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 |
What NCT03054831 shows while recruiting
NCT03054831 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03054831's enrollment target sits among peer trials
40 1397th of 2000 higher than 534 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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