Trial Outcomes & Findings for Effectiveness of IV Acetaminophen and IV Ibuprofen in Reducing Post Procedural Pain in the UFE Procedure (NCT NCT02227316)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

40 participants

Primary outcome timeframe

24 hours

Results posted on

2018-06-08

Participant Flow

No participants were excluded before assignment to groups.

Participant milestones

Participant milestones
Measure	Intravenous Ibuprofen Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4. IV Ibuprofen	Intravenous Acetaminophen Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4 IV Acetaminophen	IV Ibuprofen/IV Acetaminophen Ibuprofen 800 mg/ Acetaminophen 1 gram IV piggyback and Saline IVP 6 hours x 4 IV Ibuprofen IV Acetaminophen	Intravenous Placebo/Intravenous Placebo Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4 IV Placebo
Overall Study STARTED	4	4	16	16
Overall Study COMPLETED	4	4	16	16
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intravenous Ibuprofen n=4 Participants Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4. IV Ibuprofen	Intravenous Acetaminophen n=4 Participants Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4 IV Acetaminophen	IV Ibuprofen/IV Acetaminophen n=16 Participants Ibuprofen 800 mg/ Acetaminophen 1 gram IV piggyback and Saline IVP 6 hours x 4 IV Ibuprofen IV Acetaminophen	Intravenous Placebo/Intravenous Placebo n=16 Participants Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4 IV Placebo	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	16 Participants n=5 Participants	16 Participants n=4 Participants	40 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	41.96 years STANDARD_DEVIATION 3.22 • n=5 Participants	45.24 years STANDARD_DEVIATION 6.31 • n=7 Participants	44.33 years STANDARD_DEVIATION 4.32 • n=5 Participants	44.49 years STANDARD_DEVIATION 4.12 • n=4 Participants	44.25 years STANDARD_DEVIATION 4.27 • n=21 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	16 Participants n=5 Participants	16 Participants n=4 Participants	40 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	4 Participants n=5 Participants	4 Participants n=7 Participants	16 Participants n=5 Participants	16 Participants n=4 Participants	40 Participants n=21 Participants

PRIMARY outcome

Timeframe: 24 hours

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.

Outcome measures

Outcome measures
Measure	Intravenous Ibuprofen n=4 Participants Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4. IV Ibuprofen	Intravenous Acetaminophen n=4 Participants Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4 IV Acetaminophen	IV Ibuprofen/IV Acetaminophen n=16 Participants Ibuprofen 800 mg/ Acetaminophen 1 gram IV piggyback and Saline IVP 6 hours x 4 IV Ibuprofen IV Acetaminophen	Intravenous Placebo/Intravenous Placebo n=16 Participants Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4 IV Placebo
Evaluation of Maximum Pain Intensity Change Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen	6.48 units on a scale Standard Deviation 0.21	7.27 units on a scale Standard Deviation 1.17	6.16 units on a scale Standard Deviation 0.59	5.30 units on a scale Standard Deviation 1.45

PRIMARY outcome

Timeframe: 24 hours

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.

Outcome measures

Outcome measures
Measure	Intravenous Ibuprofen n=4 Participants Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4. IV Ibuprofen	Intravenous Acetaminophen n=4 Participants Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4 IV Acetaminophen	IV Ibuprofen/IV Acetaminophen n=16 Participants Ibuprofen 800 mg/ Acetaminophen 1 gram IV piggyback and Saline IVP 6 hours x 4 IV Ibuprofen IV Acetaminophen	Intravenous Placebo/Intravenous Placebo n=16 Participants Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4 IV Placebo
Evaluation of Mean Pain Intensity Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen	4.52 units on a scale Standard Deviation 1.19	4.22 units on a scale Standard Deviation 0.92	3.90 units on a scale Standard Deviation 1.39	3.34 units on a scale Standard Deviation 1.07

SECONDARY outcome

Timeframe: 24 hours

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.

Outcome measures

Outcome measures
Measure	Intravenous Ibuprofen n=4 Participants Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4. IV Ibuprofen	Intravenous Acetaminophen n=4 Participants Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4 IV Acetaminophen	IV Ibuprofen/IV Acetaminophen n=16 Participants Ibuprofen 800 mg/ Acetaminophen 1 gram IV piggyback and Saline IVP 6 hours x 4 IV Ibuprofen IV Acetaminophen	Intravenous Placebo/Intravenous Placebo n=16 Participants Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4 IV Placebo
Mean Nausea Intensity	1.52 units on a scale Standard Deviation 0.91	3.20 units on a scale Standard Deviation 0.80	3.59 units on a scale Standard Deviation 0.35	2.38 units on a scale Standard Deviation 0.79

SECONDARY outcome

Timeframe: 24 hours

Mean opioid consumption in morphine equivalents over 24 hours

Outcome measures

Outcome measures
Measure	Intravenous Ibuprofen n=4 Participants Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4. IV Ibuprofen	Intravenous Acetaminophen n=4 Participants Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4 IV Acetaminophen	IV Ibuprofen/IV Acetaminophen n=16 Participants Ibuprofen 800 mg/ Acetaminophen 1 gram IV piggyback and Saline IVP 6 hours x 4 IV Ibuprofen IV Acetaminophen	Intravenous Placebo/Intravenous Placebo n=16 Participants Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4 IV Placebo
Opioid Consumption	75.75 Morphine equivalent Standard Deviation 38.53	69.63 Morphine equivalent Standard Deviation 7.30	48.44 Morphine equivalent Standard Deviation 22.42	62.28 Morphine equivalent Standard Deviation 35.02

SECONDARY outcome

Timeframe: 24 hours

Mean dose of anti-emetic medication in milligrams given over 24 hours

Outcome measures

Outcome measures
Measure	Intravenous Ibuprofen n=4 Participants Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4. IV Ibuprofen	Intravenous Acetaminophen n=4 Participants Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4 IV Acetaminophen	IV Ibuprofen/IV Acetaminophen n=16 Participants Ibuprofen 800 mg/ Acetaminophen 1 gram IV piggyback and Saline IVP 6 hours x 4 IV Ibuprofen IV Acetaminophen	Intravenous Placebo/Intravenous Placebo n=16 Participants Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4 IV Placebo
Anti-Emetic Consumption	16.00 Milligrams Standard Deviation 8.64	19.50 Milligrams Standard Deviation 7.30	22.25 Milligrams Standard Deviation 7.72	19.50 Milligrams Standard Deviation 11.76

SECONDARY outcome

Timeframe: 24 hours

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.

Outcome measures

Outcome measures
Measure	Intravenous Ibuprofen n=4 Participants Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4. IV Ibuprofen	Intravenous Acetaminophen n=4 Participants Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4 IV Acetaminophen	IV Ibuprofen/IV Acetaminophen n=16 Participants Ibuprofen 800 mg/ Acetaminophen 1 gram IV piggyback and Saline IVP 6 hours x 4 IV Ibuprofen IV Acetaminophen	Intravenous Placebo/Intravenous Placebo n=16 Participants Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4 IV Placebo
Maximum Nausea Intensity	5.62 units on a scale Standard Deviation 2.88	5.25 units on a scale Standard Deviation 1.07	6.41 units on a scale Standard Deviation 0.94	3.71 units on a scale Standard Deviation 0.29

Adverse Events

Intravenous Ibuprofen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intravenous Acetaminophen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

IV Ibuprofen/IV Acetaminophen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intravenous Placebo/Intravenous Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Research

UCLA Department of Radiological Sciences

Phone: 310-794-8995

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place