Trial Outcomes & Findings for Efficacy of Intravenous Ibuprofen Compared to Intravenous Ketorolac for Pain Control Following Arthroscopic Knee Surgery (NCT NCT01901393)

NCT ID: NCT01901393

Last Updated: 2016-03-14

Results Overview

Pain assessed using VAS (Visual Analog Scale, VAS). The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between 0 (No Pain) and 100 (Worst Possible Pain).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

First possible time post-surgery, an expected average of 6 hours

Results posted on

2016-03-14

Participant Flow

Participant milestones

Participant milestones
Measure	IV Ibuprofen 800mg ibuprofen IV ibuprofen	Ketorolac 30mg ketorolac Ketorolac
Overall Study STARTED	51	49
Overall Study COMPLETED	50	49
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	IV Ibuprofen 800mg ibuprofen IV ibuprofen	Ketorolac 30mg ketorolac Ketorolac
Overall Study Adverse Event	1	0

Baseline Characteristics

Efficacy of Intravenous Ibuprofen Compared to Intravenous Ketorolac for Pain Control Following Arthroscopic Knee Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IV Ibuprofen n=51 Participants 800mg ibuprofen IV ibuprofen	Ketorolac n=49 Participants 30mg ketorolac Ketorolac	Total n=100 Participants Total of all reporting groups
Age, Continuous	45 years STANDARD_DEVIATION 13.3 • n=5 Participants	46 years STANDARD_DEVIATION 15.5 • n=7 Participants	46 years STANDARD_DEVIATION 14.4 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	21 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	28 Participants n=7 Participants	61 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants n=5 Participants	47 Participants n=7 Participants	96 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	44 Participants n=5 Participants	48 Participants n=7 Participants	92 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	51 participants n=5 Participants	49 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: First possible time post-surgery, an expected average of 6 hours

Population: This analysis was performed on all subject who completed the VAS at Rest Immediately Following their Procedure

Outcome measures

Outcome measures
Measure	IV Ibuprofen n=50 Participants 800mg ibuprofen IV ibuprofen	Ketorolac n=49 Participants 30mg ketorolac Ketorolac
Efficacy of Pain Relief (Pain Intensity at Rest)	30 units on a scale (in mm) Standard Deviation 27.0	32 units on a scale (in mm) Standard Deviation 25.1

PRIMARY outcome

Timeframe: First possible time post-surgery, an expected average of 6 hours

Population: This analysis was performed on all subject who completed the VAS with Movement Immediately Following their Procedure

Outcome measures

Outcome measures
Measure	IV Ibuprofen n=49 Participants 800mg ibuprofen IV ibuprofen	Ketorolac n=47 Participants 30mg ketorolac Ketorolac
Efficacy of Pain Relief (Pain Intensity With Movement)	32 units on a scale (in mm) Standard Deviation 28.0	41 units on a scale (in mm) Standard Deviation 28.2

SECONDARY outcome

Timeframe: Post-operative period until discharge, an expected average of 6 hours

Amount of rescue medication (in milligrams) will be measured

Outcome measures

Outcome measures
Measure	IV Ibuprofen n=51 Participants 800mg ibuprofen IV ibuprofen	Ketorolac n=49 Participants 30mg ketorolac Ketorolac
Rescue Medication Use in Post-operative Period Narcotic	13.7 milligrams Standard Deviation 17.19	13.2 milligrams Standard Deviation 16.50
Rescue Medication Use in Post-operative Period Acetaminophen	188.5 milligrams Standard Deviation 255.06	179.1 milligrams Standard Deviation 248.77

SECONDARY outcome

Timeframe: Post-operative period until discharge, an expected average of 6 hours

Time to first rescue medication (in hours) in the postoperative period through discharge.

Outcome measures

Outcome measures
Measure	IV Ibuprofen n=51 Participants 800mg ibuprofen IV ibuprofen	Ketorolac n=49 Participants 30mg ketorolac Ketorolac
Time to First Use of Rescue Med Will be Measured	1.2 hours Standard Error 0.11	1.2 hours Standard Error 0.10

SECONDARY outcome

Timeframe: Post-operative period until discharge, an expected average of 6 hours

Measured using 2 question, 4 point scale.

Outcome measures

Outcome measures
Measure	IV Ibuprofen n=51 Participants 800mg ibuprofen IV ibuprofen	Ketorolac n=49 Participants 30mg ketorolac Ketorolac
Patient Satisfaction Poor	0 Participants	1 Participants
Patient Satisfaction Fair	4 Participants	8 Participants
Patient Satisfaction Good	20 Participants	18 Participants
Patient Satisfaction Excellent	26 Participants	22 Participants

SECONDARY outcome

Timeframe: Post-operative period until discharge, an expected average of 6 hours

Number of subjects experiencing treatment-emergent serious adverse events

Outcome measures

Outcome measures
Measure	IV Ibuprofen n=51 Participants 800mg ibuprofen IV ibuprofen	Ketorolac n=49 Participants 30mg ketorolac Ketorolac
Incidence of Serious Adverse Events	0 Number of events	0 Number of events

Adverse Events

IV Ibuprofen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ketorolac

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

Amy Rock, PhD

Cumberland Pharmaceutical Inc.

Phone: 615-255-0068

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place