Pain
Conditions
Brief summary
The primary objective of this study is to determine the safety of a single dose of intravenous ibuprofen administered over 5-10 minutes for the preemptive treatment of postoperative pain.
Interventions
800 mg intravenous ibuprofen administered intravenously over 5-10 minutes
Sponsors
Cumberland Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for surgery with anticipated need for postoperative analgesia
Exclusion criteria
1. Patients with inadequate IV access 2. Patients \<18 years of age 3. History or allergy or hypersensitivity to any component of intravenous ibuprofen, aspirin (or aspirin related products) or non-steroidal anti-inflammatory drug (NSAIDs) 4. Active hemorrhage or clinically significant bleeding 5. Pregnant or nursing 6. Patients in the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery 7. Inability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board \[IRB\]), and agree to abide by the study restrictions 8. Refusal to provide written authorization for use and disclosure of protected health information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Determine the Safety of a Single Dose of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain. | 6 hours | The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen |
| To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain. | 6 hours | The incidence of treatment-emergent adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain. | 6 hours | The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen |
| To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain. | 6 hours | The incidence of treatment-emergent adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen |
Countries
United States
Participant flow
Recruitment details
Adult hospitalized patients undergoing surgery
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Intravenous Ibuprofen Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.
Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes | 300 |
| Total | 300 |
Baseline characteristics
| Characteristic | Intravenous Ibuprofen |
|---|---|
| Age, Customized Greater than or equal to 18 years of age | 300 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 271 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 60 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 229 Participants |
| Region of Enrollment United States | 300 participants |
| Sex: Female, Male Female | 189 Participants |
| Sex: Female, Male Male | 111 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 49 / 300 |
| serious Total, serious adverse events | 8 / 300 |
Outcome results
Primary
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.
The incidence of treatment-emergent adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen
Time frame: 6 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intravenous Ibuprofen | To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain. | 49 Number of Adverse Events |
Primary
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.
The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen
Time frame: 6 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intravenous Ibuprofen | To Determine the Safety of a Single Dose of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain. | 8 Number of Serious Adverse Events |
Secondary
To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.
The incidence of treatment-emergent adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen
Time frame: 6 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intravenous Ibuprofen | To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain. | 16 Number of Adverse Events |
Secondary
To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.
Visual Analog Scale (VAS) assessments following surgery. 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.
Time frame: 6 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intravenous Ibuprofen | To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain. | 30.9 units on a scale |
Secondary
To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.
The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen
Time frame: 6 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intravenous Ibuprofen | To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain. | 0 Number of Serious Adverse Events |