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NCT02227316 · ClinicalTrials.gov registry record · Phase 4
Effectiveness of IV Acetaminophen and IV Ibuprofen in Reducing Post Procedural Pain in the UFE Procedure
A Phase 4 study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT02227316 is a Phase 4 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 40 participants.
The verdict
NCT02227316, a Phase 4 study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study Summary
The uterine fibroid embolization (UFE) procedure is a treatment option for abnormal heavy menstrual bleeding and/or bulk symptoms associated with uterine fibroids and adenomyosis. Post UFE procedural pain and nausea are expected events. These symptoms are treated with current standard of care medications, including opiates. Intra procedure pain medications include midazolam, fentanyl and hydromorphone. Some centers include nonsteroidal anti-inflammatory medications (NSAIDS), including oral ibuprofen and IV ketorolac. Post procedural pain control is centered on a hydromorphone patient-controlled analgesia (PCA) infusion pump, as well as a NSAID regimen. Intra procedure and post procedure nausea control medications include a transcutaneous scopolamine patch and IV anti-nausea medications such as ondansetron and prochlorperazine. This study is being conducted to compare two new medications for pain, IV ibuprofen and IV acetaminophen, administered for 24 hours following UFE. The primary safety objective of non-inferiority will be met and the primary efficacy objective of superiority, decreased pain and nausea, will be accessed when compared to current standard of care regimens. This is a 4 arm, double blind, randomized, controlled study. All patients will receive standard of care baseline pain medications, including IV midazolam, fentanyl and hydromorphone intra procedure, followed by a hydromorphone PCA infusion pump post procedure. The 4 arms will include: \[ Arm 1\] IV ibuprofen/IV placebo, \[Arm 2\] IV acetaminophen/IV placebo, \[Arm 3\] IV ibuprofen/IV acetaminophen, and \[arm 4\] IV placebo/IV placebo. These medications will be given during the procedure and extended over a 24 hour stay. Arm 4 (IV placebo/IV placebo) would replicate current standard of care, and therefore will include IV push (IVP) ketorolac, which would be given at the end of the procedure and be continued every 6 hours for the 24 hour stay. An IVP of saline will be given as a control every 6
Interventions
- DRUG IV Acetaminophen
- DRUG IV Ibuprofen
- DRUG Intravenous placebo/Intravenous placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2014-08 |
| Est. Completion | 2016-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02227316
The ClinicalTrials.gov registry entry for NCT02227316 describes a study currently listed as completed, 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 University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which IV Acetaminophen is the first listed.
NCT02227316 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02227316 about?
NCT02227316 is a clinical study titled "Effectiveness of IV Acetaminophen and IV Ibuprofen in Reducing Post Procedural Pain in the UFE Procedure". The uterine fibroid embolization (UFE) procedure is a treatment option for abnormal heavy menstrual bleeding and/or bulk symptoms associated with uterine fibroids and adenomyosis. Post UFE procedural pain and nausea are expected events. These symptoms are treated with current standard of care medica...
What is the current status of trial NCT02227316?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2014-08. Estimated completion is 2016-09.
What interventions are being tested in trial NCT02227316?
The interventions under investigation include: IV Acetaminophen (DRUG), IV Ibuprofen (DRUG), Intravenous placebo/Intravenous placebo (DRUG).
Who is sponsoring clinical trial NCT02227316?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
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