Overview

This trial is active, not recruiting.

Condition symptomatic uterine fibroids and adenomyosis
Treatments iv ibuprofen, iv acetaminophen, iv placebo
Phase phase 4
Sponsor University of California, Los Angeles
Collaborator Sponsor Name Pending
Start date August 2014
End date September 2016
Trial size 40 participants
Trial identifier NCT02227316, 14000359

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose supportive care
Arm
(Experimental)
Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4.
iv ibuprofen
(Experimental)
Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4
iv acetaminophen
(Experimental)
Ibuprofen 800 mg/ Acetaminophen 1 gram IV piggyback and Saline IVP 6 hours x 4
iv ibuprofen
iv acetaminophen
(Active Comparator)
Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4
iv placebo

Primary Outcomes

Measure
Evaluation of pain intensity reduction over 24 hours with the addition of IV acetaminophen and IV ibuprofen
time frame: 24 hours

Secondary Outcomes

Measure
Nausea reduction
time frame: 24 hours

Eligibility Criteria

Female participants from 21 years up to 60 years old.

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

Additional Information

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
Principal investigator Cheryl H Hoffman, MD
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. 1. 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. 2. 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. 3. 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. 4. Variables measured: pain (VAS score at 0 hours, 6 hours, discharge and 2 weeks post procedure), opioid requirements, 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). 5. 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. 6. 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. 7. 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)
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University of California, Los Angeles.