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

NCT02227316 | Completed Phase 4 Results

• 1 other identifier: 14000359
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Symptomatic Uterine Fibroids and Adenomyosis

Keywords

Uterine Fibroid Embolization; Pain; UFE; Fibroids; Adenomyosis; Bleeding; IV Acetaminophen; IV Ibuprofen; Menorrhagia; Leiomyoma; Patient Satisfaction

Outcome Measures

Primary Outcomes (2)

• 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.

  24 hours

• 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.

  24 hours

Secondary Outcomes (4)

• Mean Nausea Intensity

  24 hours

• Opioid Consumption

  24 hours

• Anti-Emetic Consumption

  24 hours

• Maximum Nausea Intensity

  24 hours

Study Arms (4)

Intravenous Ibuprofen

EXPERIMENTAL

Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4 during uterine fibroid embolization

Drug: IV Ibuprofen

Intravenous acetaminophen

EXPERIMENTAL

Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4 during uterine fibroid embolization

Drug: IV Acetaminophen

IV ibuprofen/IV acetaminophen

EXPERIMENTAL

Ibuprofen 800 mg/ Acetaminophen 1 gram IV piggyback and Saline IVP 6 hours x 4 during uterine fibroid embolization

Drug: IV Ibuprofen; Drug: IV Acetaminophen

Intravenous placebo/Intravenous placebo

ACTIVE COMPARATOR

Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4 during uterine fibroid embolization

Drug: Intravenous placebo/Intravenous placebo

Interventions

IV Ibuprofen DRUG

Uterine fibroid embolization

Also known as: Uterine artery embolization

IV ibuprofen/IV acetaminophen; Intravenous Ibuprofen

IV Acetaminophen DRUG

Uterine fibroid embolization

Also known as: Uterine artery embolization

IV ibuprofen/IV acetaminophen; Intravenous acetaminophen

Intravenous placebo/Intravenous placebo DRUG

Uterine fibroid embolization

Also known as: Uterine artery embolization

Intravenous placebo/Intravenous placebo

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients being considered for UFE including bleeding and/or bulk symptoms.
• Women of all ethnicities
• Ages 21-60

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Sponsor Name Pending: collaborator

Study Sites (2)

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Santa Monica/UCLA Medical Center and Orthopaedic Hospital

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Adenomyosis; Pain; Leiomyoma; Hemorrhage; Menorrhagia; Patient Satisfaction

Interventions

Ibuprofen; Uterine Artery Embolization; Acetaminophen

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Pathologic Processes; Uterine Hemorrhage; Menstruation Disturbances; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Embolization, Therapeutic; Hemostatic Techniques; Therapeutics; Therapeutic Occlusion; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Results Point of Contact

• Title: Director of Clinical Research
• Organization: UCLA Department of Radiological Sciences

schaabane@mednet.ucla.edu

310-794-8995

Study Officials

• Cheryl H Hoffman, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Jonathan S Jahr, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD.

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: August 28, 2014
• Study Start: August 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: June 8, 2018
• Results First Posted: June 8, 2018

Record last verified: 2018-06

Locations

US (2)