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Oral Oxycodone for Pediatric Post-Surgical Pain
Study Summary
This trial will help researchers learn more about how the commonly prescribed painkiller oxycodone affects children by studying its metabolic activity and performing genetic testing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My child is not on any CYP3A4 or CYP2D6 affecting drugs and has no allergy to oxycodone.My child does not have sleep apnea or breathing problems.My child is healthy, hasn't used opioids, and is having specific surgery.My child does not have conditions affecting drug processing in their body.
- Group 1: oral oxycodone
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many individuals have signed up to participate in this clinical research?
"Affirmative. Clinicaltrials.gov describes this medical experiment as actively seeking participants, which was initially published on May 1st 2014 and recently updated on June 6th 2022. 68 volunteers are needed from one location for the study to be completed successfully."
Are there any open enrollment opportunities for the current clinical trial?
"Clinicaltrials.gov states this clinical trial is actively recruiting participants, having been posted on May 1st 2014 and most recently revised on June 6th 2022."
Has the Food and Drug Administration validated oral oxycodone for medical use?
"We have assigned a risk rating of 3 to oxycodone due to the fact it has been authorised by Phase 4 trials and thus there is solid evidence for its safety."
Are there precedents of research utilizing oral oxycodone?
"Presently, there are 25 clinical trials in progress investigating the use of oral oxycodone. Of those, 6 are currently at Phase 3. Most of these trials can be found in Philadelphia but they exist across 28 different sites."
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