Trial Outcomes & Findings for Assessing the Efficacy of IV Ibuprofen for Treatment of Pain in Orthopedic Trauma Patients (NCT NCT02152163)
NCT ID: NCT02152163
Last Updated: 2021-07-12
Results Overview
Outcome measure based on morphine equivalent dosage comparing the two groups
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
99 participants
Primary outcome timeframe
morphine equivalent dosage in over 48 hours after admission
Results posted on
2021-07-12
Participant Flow
Participant milestones
| Measure |
IV Ibuprofen 800 mg
IV Ibuprofen 800 mg
IV Ibuprofen
|
IV Saline
IV Saline
placebo
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
48
|
|
Overall Study
COMPLETED
|
39
|
35
|
|
Overall Study
NOT COMPLETED
|
12
|
13
|
Reasons for withdrawal
| Measure |
IV Ibuprofen 800 mg
IV Ibuprofen 800 mg
IV Ibuprofen
|
IV Saline
IV Saline
placebo
|
|---|---|---|
|
Overall Study
Physician Decision
|
12
|
13
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
IV Ibuprofen 800 mg
n=39 Participants
IV Ibuprofen 800 mg
IV Ibuprofen
|
IV Saline
n=35 Participants
IV Saline
placebo
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=74 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=39 Participants
|
35 Participants
n=35 Participants
|
74 Participants
n=74 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=74 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=39 Participants
|
7 Participants
n=35 Participants
|
16 Participants
n=74 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=39 Participants
|
28 Participants
n=35 Participants
|
58 Participants
n=74 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
39 Participants
n=39 Participants
|
35 Participants
n=35 Participants
|
74 Participants
n=74 Participants
|
PRIMARY outcome
Timeframe: morphine equivalent dosage in over 48 hours after admissionOutcome measure based on morphine equivalent dosage comparing the two groups
Outcome measures
| Measure |
IV Ibuprofen 800 mg
n=39 Participants
IV Ibuprofen 800 mg
IV Ibuprofen
|
IV Saline
n=35 Participants
IV Saline
placebo
|
|---|---|---|
|
Efficacy of IV Ibuprofen in Orthropedic Trauma Patients
|
74.9 morphine equivalent dosage, mg
Interval 62.1 to 87.8
|
97.8 morphine equivalent dosage, mg
Interval 84.4 to 111.2
|
Adverse Events
IV Ibuprofen 800 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IV Saline
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place