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

Primary Purpose

Symptomatic Uterine Fibroids and Adenomyosis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
IV Ibuprofen
IV Acetaminophen
Intravenous placebo/Intravenous placebo
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

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

21 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

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

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Intravenous Ibuprofen

Intravenous acetaminophen

IV ibuprofen/IV acetaminophen

Intravenous placebo/Intravenous placebo

Arm Description

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

Outcomes

Primary Outcome Measures

Evaluation of Maximum Pain Intensity Change Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen
Primary efficacy objective is to compare the change in maximum level of pain experienced by patient 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 a visual analog scale (VAS) from 0 to 10, 0 signifying no pain and 10 signifying the worst possible pain. The scores reported are the mean of all patients' VAS scores in each respective category.
Evaluation of Mean Pain Intensity Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen
Primary efficacy objective is to compare the change in mean 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 a visual analog scale (VAS) from 0 to 10, 0 signifying no pain and 10 signifying the worst possible pain. The scores reported are the mean of all patients' VAS scores in each respective category.

Secondary Outcome Measures

Mean Nausea Intensity
Assessment of mean nausea by mean of VAS scores over a 24-hour period. VAS score is measured using a scale of 0 to 10, 0 signifying no nausea and 10 signifying the worst possible nausea. The scores reported are the mean of all patients' VAS scores in each respective category.
Opioid Consumption
Mean opioid consumption in morphine equivalents over 24 hours
Anti-Emetic Consumption
Mean dose of anti-emetic medication in milligrams given over 24 hours
Maximum Nausea Intensity
Assessment of maximum level of nausea experienced by patient, by mean of VAS scores over a 24-hour period. VAS score is measured using a scale of 0 to 10, 0 signifying no nausea and 10 signifying the worst possible nausea. The scores reported are the mean of all patients' VAS scores in each respective category.

Full Information

First Posted
August 26, 2014
Last Updated
June 5, 2018
Sponsor
University of California, Los Angeles
Collaborators
Sponsor Name Pending
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1. Study Identification

Unique Protocol Identification Number
NCT02227316
Brief Title
Effectiveness of IV Acetaminophen and IV Ibuprofen in Reducing Post Procedural Pain in the UFE Procedure
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 Fibroid Embolization Procedure
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Sponsor Name Pending

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.
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 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. Variables measured: mean and maximum pain (VAS score at 0 hours, 6 hours, discharge and 2 weeks post procedure), opioid requirements, mean and maximum nausea (VAS score at 0 hours, 6 hours, discharge and 2 weeks post procedure), anti-emetic medication requirements. Weighted sum of pain intensity differences, with pain intensity measured on VAS over 24 hours (SPID24) will be used as a primary outcome. Satisfaction scores will be measured at 24 hours using the validated APS-POQ-R questionnaire (6). Other variables recorded: Age, height, weight, history of postoperative nausea and vomiting or motion sickness, diagnosis, uterine volume, dominant fibroid size, arteries embolized, presence of prominent ovarian arteries, volume of particle used, fluoroscopy time for the procedure. Technical parameters, which would remain constant, include: pre procedure and 6 month follow up MRI contrast with gadolinium which is standard of care, embolization using 500-700 micron Embospheres (with limited use of 700-900 micron Embospheres), IV hydration with 0.9% normal saline, antibiotics (IV ciprofloxacin 400 mg every 12 hours, IV metronidazole 500 mg every six hours), urinary catheter placement, lower extremity compression devices, and early ambulation. In the interim analysis, the investigators will have 40 subjects in total with unequal randomization ratio of 1:1:4:4. Additional subjects will be enrolled for a total of 35 subjects per arm for the final analysis (sum total N=140)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Uterine Fibroids and Adenomyosis
Keywords
Uterine Fibroid Embolization, Pain, UFE, Fibroids, Adenomyosis, Bleeding, IV Acetaminophen, IV Ibuprofen, Menorrhagia, Leiomyoma, Patient Satisfaction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous Ibuprofen
Arm Type
Experimental
Arm Description
Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4 during uterine fibroid embolization
Arm Title
Intravenous acetaminophen
Arm Type
Experimental
Arm Description
Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4 during uterine fibroid embolization
Arm Title
IV ibuprofen/IV acetaminophen
Arm Type
Experimental
Arm Description
Ibuprofen 800 mg/ Acetaminophen 1 gram IV piggyback and Saline IVP 6 hours x 4 during uterine fibroid embolization
Arm Title
Intravenous placebo/Intravenous placebo
Arm Type
Active Comparator
Arm Description
Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4 during uterine fibroid embolization
Intervention Type
Drug
Intervention Name(s)
IV Ibuprofen
Other Intervention Name(s)
Uterine artery embolization
Intervention Description
Uterine fibroid embolization
Intervention Type
Drug
Intervention Name(s)
IV Acetaminophen
Other Intervention Name(s)
Uterine artery embolization
Intervention Description
Uterine fibroid embolization
Intervention Type
Drug
Intervention Name(s)
Intravenous placebo/Intravenous placebo
Other Intervention Name(s)
Uterine artery embolization
Intervention Description
Uterine fibroid embolization
Primary Outcome Measure Information:
Title
Evaluation of Maximum Pain Intensity Change Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen
Description
Primary efficacy objective is to compare the change in maximum level of pain experienced by patient 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 a visual analog scale (VAS) from 0 to 10, 0 signifying no pain and 10 signifying the worst possible pain. The scores reported are the mean of all patients' VAS scores in each respective category.
Time Frame
24 hours
Title
Evaluation of Mean Pain Intensity Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen
Description
Primary efficacy objective is to compare the change in mean 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 a visual analog scale (VAS) from 0 to 10, 0 signifying no pain and 10 signifying the worst possible pain. The scores reported are the mean of all patients' VAS scores in each respective category.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Mean Nausea Intensity
Description
Assessment of mean nausea by mean of VAS scores over a 24-hour period. VAS score is measured using a scale of 0 to 10, 0 signifying no nausea and 10 signifying the worst possible nausea. The scores reported are the mean of all patients' VAS scores in each respective category.
Time Frame
24 hours
Title
Opioid Consumption
Description
Mean opioid consumption in morphine equivalents over 24 hours
Time Frame
24 hours
Title
Anti-Emetic Consumption
Description
Mean dose of anti-emetic medication in milligrams given over 24 hours
Time Frame
24 hours
Title
Maximum Nausea Intensity
Description
Assessment of maximum level of nausea experienced by patient, by mean of VAS scores over a 24-hour period. VAS score is measured using a scale of 0 to 10, 0 signifying no nausea and 10 signifying the worst possible nausea. The scores reported are the mean of all patients' VAS scores in each respective category.
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl H Hoffman, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jonathan S Jahr, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Santa Monica/UCLA Medical Center and Orthopaedic Hospital
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States

12. IPD Sharing Statement

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

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