Effectiveness of IV Acetaminophen and IV Ibuprofen in Reducing Post Procedural Pain in the UFE Procedure
Symptomatic Uterine Fibroids and Adenomyosis
About this trial
This is an interventional supportive care trial for Symptomatic Uterine Fibroids and Adenomyosis focused on measuring Uterine Fibroid Embolization, Pain, UFE, Fibroids, Adenomyosis, Bleeding, IV Acetaminophen, IV Ibuprofen, Menorrhagia, Leiomyoma, Patient Satisfaction
Eligibility Criteria
Inclusion Criteria:
- Patients being considered for UFE including bleeding and/or bulk symptoms.
- Women of all ethnicities
- Ages 21-60
Exclusion Criteria:
- Patients with current malignancy receiving treatment
- Women who are pregnant
- Cognitive impairment
- Clinically significant kidney disease
- Clinically significant liver disease
- Any recent history of gastrointestinal bleed or ulcer
- Weight less than 50 kg (medication dosing requirements change below 50 kg)
- Women with a body mass index (BMI) equal to or over 50 (with other co-morbidities)
- Known allergy or hypersensitivity to NSAID or acetaminophen
- Administration of acetaminophen, NSAID, narcotic or any other analgesic less than 6 hours prior to UFE procedure
- Any chronic use of pain medications including acetaminophen, NSAID, narcotic or analgesic
- Patients who cannot or choose not to consent to participate in the study
Sites / Locations
- Ronald Reagan UCLA Medical Center
- Santa Monica/UCLA Medical Center and Orthopaedic Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Active Comparator
Intravenous Ibuprofen
Intravenous acetaminophen
IV ibuprofen/IV acetaminophen
Intravenous placebo/Intravenous placebo
Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4 during uterine fibroid embolization
Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4 during uterine fibroid embolization
Ibuprofen 800 mg/ Acetaminophen 1 gram IV piggyback and Saline IVP 6 hours x 4 during uterine fibroid embolization
Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4 during uterine fibroid embolization