Effectiveness of IV Acetaminophen and IV Ibuprofen in Reducing Post Procedural Pain in the UFE Procedure

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.

Conditions

• Symptomatic Uterine Fibroids and Adenomyosis

Interventions

DRUG

IV Ibuprofen

Uterine fibroid embolization

DRUG

IV Acetaminophen

Uterine fibroid embolization

DRUG

Intravenous placebo/Intravenous placebo

Uterine fibroid embolization

Sponsors & Collaborators

• Sponsor Name Pending

  collaborator INDUSTRY

• University of California, Los Angeles

  lead OTHER

Principal Investigators

• Cheryl H Hoffman, MD · University of California, Los Angeles

• Jonathan S Jahr, MD · University of California, Los Angeles

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-08-31

Primary Completion

2016-09-30

Completion

2016-09-30

Countries

• United States

Study Locations