Clinical Trial: Effectiveness of IV Acetaminophen and IV Ibuprofen in Reducing Post Procedural Pain in the UFE Procedure
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Prospective, Double Blind, Randomized, Placebo Controlled Study to Compare the Effectiveness of Intravenous Acetaminophen and Intravenous Ibuprofen in Reducing Post Procedural Pain in the Uterine Fi
Brief 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 replica
Detailed Summary:
A prospective, double blind, randomized controlled trial evaluating the effects of two new IV medications, IV ibuprofen and IV acetaminophen, on standard of care pain and anti-emetic management in Uterine Fibroid Embolization patients.
- Four arm, double blind, randomized controlled study: all patients will receive standard of care baseline pain medications, including IV midazolam, fentanyl and hydromorphone during the procedure, followed by a hydromorphone PCA infusion pump during their recovery. The four arms will include an IV ibuprofen/IV placebo, an IV acetaminophen/IV placebo, an IV ibuprofen/IV acetaminophen, and a control arm (IV placebo/IV placebo). The same amount of normal saline will be substituted for the experimental treatments if the patient receives the placebo. These medications will be given during the procedure and extended over a 24 hour recovery period. The medications given will be blinded to the patient, the administrator, and the surveyor.
- The placebo/placebo arm would replicate current standard of care, and therefore include IV push (IVP) ketorolac, which would be given at the end of the procedure and be continued for 24 hours at q6hour dosing. An IVP of saline would be given as a control for 24 hours at q6hour dosing to the other three arms.
- Dosage of medications will be standardized based on formulary indications: IV Ketorolac 30 mg/dose IVP, acetaminophen 1 gram/dose IV piggy back over 15 minutes every 6 hours, ibuprofen 800 mg/dose IV piggy back over 30 minutes every 6 hours.
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Variables measured: pain (VAS score at 0 hours, 6 hours, discharge and 2 weeks post procedure), opioid requirements, nausea (VAS score at 0 hours, 6 hours, discharge and 2 weeks post procedure
Sponsor: University of California, Los Angeles
Current Primary Outcome: Evaluation of pain intensity reduction over 24 hours with the addition of IV acetaminophen and IV ibuprofen [ Time Frame: 24 hours ]
Primary efficacy objective is to compare the reduction in pain intensity score over 24 hours between IV acetaminophen and IV ibuprofen (alone and in combination), and the current standard of care medication regimen. This comparison will be measured using SPID 24 (sum of pain intensity differences over 24 hours, a validated pain measurement used by the FDA for drug approvals), and evaluation of opioid requirement.
Original Primary Outcome: Same as current
Current Secondary Outcome: Nausea reduction [ Time Frame: 24 hours ]
Assessment of nausea by VAS scores over 24 hours and evaluation of anti-emetic medication requirement.
Original Secondary Outcome: Same as current
Information By: University of California, Los Angeles
Dates:
Date Received: August 26, 2014
Date Started: August 2014
Date Completion:
Last Updated: May 18, 2017
Last Verified: May 2017
