Effectiveness of IV Acetaminophen and IV Ibuprofen in Reducing Post Procedural Pain in the UFE Procedure
Status:
Completed
Trial end date:
2016-09-01
Target enrollment:
Participant gender:
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 hours for the 24 hour stay to arms 1, 2 and 3. Pain and nausea will be measured at
intervals prior to the procedure, throughout the stay and at 2 weeks post procedure.