Effectiveness of IV Acetaminophen and IV Ibuprofen in Reducing Post Procedural Pain in the UFE Procedure
Condition: Symptomatic Uterine Fibroids and Adenomyosis
MeSH terms: Leiomyoma; Myofibroma; Adenomyosis; Pain, Procedural
Intervention: IV Ibuprofen; IV Acetaminophen; Intravenous placebo/Intravenous placebo
Intervention description: Uterine fibroid embolization; Uterine fibroid embolization; Uterine fibroid embolization
Intervention MeSH terms: Acetaminophen; Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: Female
Minimum age: 21 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Uterine Fibroid Embolization; Pain; UFE; Fibroids; Adenomyosis; Bleeding; IV Acetaminophen; IV Ibuprofen; Menorrhagia; Leiomyoma; Patient Satisfaction

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients being considered for UFE including bleeding and/or bulk symptoms.

          2. Women of all ethnicities

          3. Ages 21-60

        Exclusion Criteria:

          1. Patients with current malignancy receiving treatment

          2. Women who are pregnant

          3. Cognitive impairment

          4. Clinically significant kidney disease

          5. Clinically significant liver disease

          6. Any recent history of gastrointestinal bleed or ulcer

          7. Weight less than 50 kg (medication dosing requirements change below 50 kg)

          8. Women with a body mass index (BMI) equal to or over 50 (with other co-morbidities)

          9. Known allergy or hypersensitivity to NSAID or acetaminophen

         10. Administration of acetaminophen, NSAID, narcotic or any other analgesic less than 6
             hours prior to UFE procedure

         11. Any chronic use of pain medications including acetaminophen, NSAID, narcotic or
             analgesic

         12. Patients who cannot or choose not to consent to participate in the study