Trial Outcomes & Findings for Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen (NCT NCT01334944)
NCT ID: NCT01334944
Last Updated: 2023-07-05
Results Overview
The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
150 participants
Primary outcome timeframe
6 hours
Results posted on
2023-07-05
Participant Flow
Adult patients in the hospital setting experiencing pain and/or fever.
Patients who met all the inclusion and none of the exclusion criteria during the Screening /Baseline Period were enrolled into the study. Subjects could not have a history of allergy or hypersensitivity to any component of intravenous ibuprofen, aspirin (or aspirin related products) or NSAIDS.
Participant milestones
| Measure |
Fever
Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
|
Pain
Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
139
|
|
Overall Study
Received Singel Dose
|
1
|
96
|
|
Overall Study
Received Multiple Doses
|
10
|
43
|
|
Overall Study
COMPLETED
|
11
|
139
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen
Baseline characteristics by cohort
| Measure |
Intravenous Ibuprofen
n=150 Participants
Intravenous ibuprofen (400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
Intravenous ibuprofen: 400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes
|
|---|---|
|
Age, Customized
Greater than or equal to 18 years of age
|
150 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
106 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
150 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 hoursThe incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen
Outcome measures
| Measure |
Fever
n=11 Participants
Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
|
Pain
n=139 Participants
Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
|
|---|---|---|
|
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.
|
0 Number of Serious Adverse Events
|
0 Number of Serious Adverse Events
|
PRIMARY outcome
Timeframe: 6 hoursPopulation: This analysis was conducted on participants treated with a fever or pain indication that received only a single dose of intravenous ibuprofen
The incidence of treatment-emergent adverse events occurring in the six hours following administration of intravenous ibuprofen.
Outcome measures
| Measure |
Fever
n=1 Participants
Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
|
Pain
n=96 Participants
Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
|
|---|---|---|
|
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.
|
0 Number of Events
|
16 Number of Events
|
PRIMARY outcome
Timeframe: 1 hourThe change from baseline to one hour post administration of intravenous ibuprofen in vitals sign assessments (Temperature)
Outcome measures
| Measure |
Fever
n=11 Participants
Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
|
Pain
n=139 Participants
Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
|
|---|---|---|
|
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting
|
-0.9 Degree Fahrenheit
Interval -2.7 to 0.3
|
-0.1 Degree Fahrenheit
Interval -3.2 to 1.6
|
PRIMARY outcome
Timeframe: 1 hourThe change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Heart Rate).
Outcome measures
| Measure |
Fever
n=11 Participants
Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
|
Pain
n=139 Participants
Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
|
|---|---|---|
|
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.
|
-2 Beats Per Minute
Interval -16.0 to 8.0
|
-1 Beats Per Minute
Interval -34.0 to 62.0
|
PRIMARY outcome
Timeframe: 1 hourThe change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Respiratory Rate).
Outcome measures
| Measure |
Fever
n=11 Participants
Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
|
Pain
n=139 Participants
Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
|
|---|---|---|
|
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.
|
-1 Breaths Per Minute
Interval -5.0 to 2.0
|
0 Breaths Per Minute
Interval -17.0 to 14.0
|
PRIMARY outcome
Timeframe: 1 hourThe change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Systolic Blood Pressure).
Outcome measures
| Measure |
Fever
n=11 Participants
Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
|
Pain
n=139 Participants
Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
|
|---|---|---|
|
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.
|
-8 mm Hg
Interval -56.0 to 16.0
|
-4 mm Hg
Interval -51.0 to 45.0
|
PRIMARY outcome
Timeframe: 1 hourThe change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Diastolic Blood Pressure).
Outcome measures
| Measure |
Fever
n=11 Participants
Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
|
Pain
n=139 Participants
Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
|
|---|---|---|
|
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.
|
-4 mm Hg
Interval -16.0 to 4.0
|
-3 mm Hg
Interval -49.0 to 41.0
|
SECONDARY outcome
Timeframe: 4 hoursThe change in temperature from baseline over the 4 hours following intravenous ibuprofen administration
Outcome measures
| Measure |
Fever
n=11 Participants
Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
|
Pain
Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
|
|---|---|---|
|
To Determine the Efficacy of a Single Dose of 400 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever
|
-1.5 Degree Fahrenheit
Interval -2.2 to -0.7
|
—
|
SECONDARY outcome
Timeframe: 4 hoursThe change in patient self-assessment of pain utilizing the visual analog scale (VAS) from baseline over the 4 hours following intravenous ibuprofen administration. 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 o and 100.
Outcome measures
| Measure |
Fever
n=139 Participants
Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
|
Pain
Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
|
|---|---|---|
|
To Determine the Efficacy of a Single Dose of 800 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Pain (Mild to Moderate or Moderate to Severe).
|
-27.1 units on a scale
Interval -33.5 to -20.7
|
—
|
SECONDARY outcome
Timeframe: 24 hoursThe incidence of treatment-emergent serious adverse events occurring through extended dosing.
Outcome measures
| Measure |
Fever
n=10 Participants
Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
|
Pain
n=43 Participants
Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
|
|---|---|---|
|
To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain
|
0 Number of Serious Adverse Events
|
1 Number of Serious Adverse Events
|
SECONDARY outcome
Timeframe: 24 hoursThe incidence of treatment-emergent adverse events occurring through extended dosing.
Outcome measures
| Measure |
Fever
n=10 Participants
Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
|
Pain
n=43 Participants
Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
|
|---|---|---|
|
To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain
|
0 Number of Events
|
14 Number of Events
|
Adverse Events
Fever
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pain
Serious events: 1 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fever
n=11 participants at risk
Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
|
Pain
n=139 participants at risk
Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
|
|---|---|---|
|
Vascular disorders
Hypotension
|
0.00%
0/11
|
0.72%
1/139 • Number of events 1
|
Other adverse events
| Measure |
Fever
n=11 participants at risk
Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
|
Pain
n=139 participants at risk
Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
|
|---|---|---|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.00%
0/11
|
0.72%
1/139 • Number of events 1
|
|
Injury, poisoning and procedural complications
Infusion Site Pain
|
0.00%
0/11
|
15.8%
22/139 • Number of events 24
|
|
Injury, poisoning and procedural complications
Infusion Site Warmth
|
0.00%
0/11
|
0.72%
1/139 • Number of events 1
|
|
Injury, poisoning and procedural complications
Injection Site Pain
|
0.00%
0/11
|
0.72%
1/139 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/11
|
5.8%
8/139 • Number of events 8
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11
|
3.6%
5/139 • Number of events 6
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11
|
2.2%
3/139 • Number of events 3
|
|
Investigations
Breath Sounds Abnormal
|
0.00%
0/11
|
2.9%
4/139 • Number of events 4
|
|
Investigations
Blood Creatinine Decreased
|
0.00%
0/11
|
0.72%
1/139 • Number of events 1
|
|
Investigations
Blood Pressure Systolic Increased
|
0.00%
0/11
|
0.72%
1/139 • Number of events 1
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/11
|
0.72%
1/139 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/11
|
2.9%
4/139 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
0.00%
0/11
|
0.72%
1/139 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/11
|
1.4%
2/139 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11
|
0.72%
1/139 • Number of events 1
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/11
|
0.72%
1/139 • Number of events 1
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/11
|
0.72%
1/139 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/11
|
1.4%
2/139 • Number of events 2
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/11
|
0.72%
1/139 • Number of events 1
|
|
Injury, poisoning and procedural complications
Anaemia Postoperative
|
0.00%
0/11
|
2.2%
3/139 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/11
|
2.2%
3/139 • Number of events 3
|
|
Vascular disorders
Hypotension
|
0.00%
0/11
|
1.4%
2/139 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/11
|
0.72%
1/139 • Number of events 1
|
|
Eye disorders
Blepharitis
|
0.00%
0/11
|
0.72%
1/139 • Number of events 1
|
|
Eye disorders
Dry Eyes
|
0.00%
0/11
|
0.72%
1/139 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/11
|
0.72%
1/139 • Number of events 1
|
|
Immune system disorders
Infusion Related Reaction
|
0.00%
0/11
|
0.72%
1/139 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post Procedural Oedema
|
0.00%
0/11
|
0.72%
1/139 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place