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

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ClinicalTrials.gov Identifier: NCT02227316
Recruitment Status : Completed
First Posted : August 28, 2014
Results First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Sponsor:
Collaborator:
Sponsor Name Pending
Information provided by (Responsible Party):
Cheryl Hoffman, University of California, Los Angeles

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Condition Symptomatic Uterine Fibroids and Adenomyosis
Interventions Drug: IV Ibuprofen
Drug: IV Acetaminophen
Drug: Intravenous placebo/Intravenous placebo
Enrollment 40
Recruitment Details  
Pre-assignment Details No participants were excluded before assignment to groups.
Arm/Group Title Intravenous Ibuprofen Intravenous Acetaminophen IV Ibuprofen/IV Acetaminophen Intravenous Placebo/Intravenous Placebo
Hide Arm/Group Description

Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4.

IV Ibuprofen

Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4

IV Acetaminophen

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

IV Ibuprofen

IV Acetaminophen

Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4

IV Placebo

Period Title: Overall Study
Started 4 4 16 16
Completed 4 4 16 16
Not Completed 0 0 0 0
Arm/Group Title Intravenous Ibuprofen Intravenous Acetaminophen IV Ibuprofen/IV Acetaminophen Intravenous Placebo/Intravenous Placebo Total
Hide Arm/Group Description

Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4.

IV Ibuprofen

Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4

IV Acetaminophen

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

IV Ibuprofen

IV Acetaminophen

Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4

IV Placebo

Total of all reporting groups
Overall Number of Baseline Participants 4 4 16 16 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 16 participants 16 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
4
 100.0%
16
 100.0%
16
 100.0%
40
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 4 participants 16 participants 16 participants 40 participants
41.96  (3.22) 45.24  (6.31) 44.33  (4.32) 44.49  (4.12) 44.25  (4.27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 16 participants 16 participants 40 participants
Female
4
 100.0%
4
 100.0%
16
 100.0%
16
 100.0%
40
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 4 participants 4 participants 16 participants 16 participants 40 participants
4
 100.0%
4
 100.0%
16
 100.0%
16
 100.0%
40
 100.0%
1.Primary Outcome
Title Evaluation of Maximum Pain Intensity Change Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Ibuprofen Intravenous Acetaminophen IV Ibuprofen/IV Acetaminophen Intravenous Placebo/Intravenous Placebo
Hide Arm/Group Description:

Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4.

IV Ibuprofen

Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4

IV Acetaminophen

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

IV Ibuprofen

IV Acetaminophen

Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4

IV Placebo

Overall Number of Participants Analyzed 4 4 16 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.48  (0.21) 7.27  (1.17) 6.16  (0.59) 5.30  (1.45)
2.Primary Outcome
Title Evaluation of Mean Pain Intensity Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Ibuprofen Intravenous Acetaminophen IV Ibuprofen/IV Acetaminophen Intravenous Placebo/Intravenous Placebo
Hide Arm/Group Description:

Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4.

IV Ibuprofen

Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4

IV Acetaminophen

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

IV Ibuprofen

IV Acetaminophen

Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4

IV Placebo

Overall Number of Participants Analyzed 4 4 16 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.52  (1.19) 4.22  (0.92) 3.90  (1.39) 3.34  (1.07)
3.Secondary Outcome
Title Mean Nausea Intensity
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Ibuprofen Intravenous Acetaminophen IV Ibuprofen/IV Acetaminophen Intravenous Placebo/Intravenous Placebo
Hide Arm/Group Description:

Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4.

IV Ibuprofen

Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4

IV Acetaminophen

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

IV Ibuprofen

IV Acetaminophen

Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4

IV Placebo

Overall Number of Participants Analyzed 4 4 16 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.52  (0.91) 3.20  (0.80) 3.59  (0.35) 2.38  (0.79)
4.Secondary Outcome
Title Opioid Consumption
Hide Description Mean opioid consumption in morphine equivalents over 24 hours
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Ibuprofen Intravenous Acetaminophen IV Ibuprofen/IV Acetaminophen Intravenous Placebo/Intravenous Placebo
Hide Arm/Group Description:

Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4.

IV Ibuprofen

Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4

IV Acetaminophen

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

IV Ibuprofen

IV Acetaminophen

Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4

IV Placebo

Overall Number of Participants Analyzed 4 4 16 16
Mean (Standard Deviation)
Unit of Measure: Morphine equivalent
75.75  (38.53) 69.63  (7.30) 48.44  (22.42) 62.28  (35.02)
5.Secondary Outcome
Title Anti-Emetic Consumption
Hide Description Mean dose of anti-emetic medication in milligrams given over 24 hours
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Ibuprofen Intravenous Acetaminophen IV Ibuprofen/IV Acetaminophen Intravenous Placebo/Intravenous Placebo
Hide Arm/Group Description:

Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4.

IV Ibuprofen

Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4

IV Acetaminophen

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

IV Ibuprofen

IV Acetaminophen

Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4

IV Placebo

Overall Number of Participants Analyzed 4 4 16 16
Mean (Standard Deviation)
Unit of Measure: Milligrams
16.00  (8.64) 19.50  (7.30) 22.25  (7.72) 19.50  (11.76)
6.Secondary Outcome
Title Maximum Nausea Intensity
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Ibuprofen Intravenous Acetaminophen IV Ibuprofen/IV Acetaminophen Intravenous Placebo/Intravenous Placebo
Hide Arm/Group Description:

Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4.

IV Ibuprofen

Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4

IV Acetaminophen

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

IV Ibuprofen

IV Acetaminophen

Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4

IV Placebo

Overall Number of Participants Analyzed 4 4 16 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.62  (2.88) 5.25  (1.07) 6.41  (0.94) 3.71  (0.29)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intravenous Ibuprofen Intravenous Acetaminophen IV Ibuprofen/IV Acetaminophen Intravenous Placebo/Intravenous Placebo
Hide Arm/Group Description

Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4.

IV Ibuprofen

Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4

IV Acetaminophen

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

IV Ibuprofen

IV Acetaminophen

Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4

IV Placebo

All-Cause Mortality
Intravenous Ibuprofen Intravenous Acetaminophen IV Ibuprofen/IV Acetaminophen Intravenous Placebo/Intravenous Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intravenous Ibuprofen Intravenous Acetaminophen IV Ibuprofen/IV Acetaminophen Intravenous Placebo/Intravenous Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%)   0/16 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intravenous Ibuprofen Intravenous Acetaminophen IV Ibuprofen/IV Acetaminophen Intravenous Placebo/Intravenous Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%)   0/16 (0.00%)   0/16 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Research
Organization: UCLA Department of Radiological Sciences
Phone: 310-794-8995
EMail: schaabane@mednet.ucla.edu
Layout table for additonal information
Responsible Party: Cheryl Hoffman, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02227316     History of Changes
Other Study ID Numbers: 14000359
First Submitted: August 26, 2014
First Posted: August 28, 2014
Results First Submitted: December 13, 2017
Results First Posted: June 8, 2018
Last Update Posted: June 8, 2018