Status:
COMPLETED
Effectiveness of IV Acetaminophen and IV Ibuprofen in Reducing Post Procedural Pain in the UFE Procedure
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
Sponsor Name Pending
Conditions:
Symptomatic Uterine Fibroids and Adenomyosis
Eligibility:
FEMALE
21-60 years
Phase:
PHASE4
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 ...
Detailed Description
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 Ute...
Eligibility Criteria
Inclusion
- Patients being considered for UFE including bleeding and/or bulk symptoms.
- Women of all ethnicities
- Ages 21-60
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02227316
Start Date
August 1 2014
End Date
September 1 2016
Last Update
June 8 2018
Active Locations (2)
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1
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
2
Santa Monica/UCLA Medical Center and Orthopaedic Hospital
Santa Monica, California, United States, 90404