Pain, Fever
Conditions
Keywords
Pain, Fever
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 treatment of fever or pain in the hospital setting.
Interventions
400 mg or 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
* Pain: Patients with baseline Visual Analog Scale assessment \>3, -and/or- Fever: Patients with temperature \>101°F.
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 Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting | 1 hour | The change from baseline to one hour post administration of intravenous ibuprofen in vitals sign assessments (Temperature) |
| 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. | 6 hours | The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Determine the Efficacy of a Single Dose of 400 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever | 4 hours | The change in temperature from baseline over the 4 hours following intravenous ibuprofen administration |
| 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). | 4 hours | The 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. |
| To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain | 24 hours | The incidence of treatment-emergent serious adverse events occurring through extended dosing. |
Countries
United States
Participant flow
Recruitment details
Adult patients in the hospital setting experiencing pain and/or fever.
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 (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 | 150 |
| Total | 150 |
Baseline characteristics
| Characteristic | Intravenous Ibuprofen |
|---|---|
| Age, Customized Greater than or equal to 18 years of age | 150 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 34 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 106 Participants |
| Region of Enrollment United States | 150 participants |
| Sex: Female, Male Female | 91 Participants |
| Sex: Female, Male Male | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 43 / 139 |
| serious Total, serious adverse events | 0 / 11 | 1 / 139 |
Outcome results
Primary
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
The change from baseline to one hour post administration of intravenous ibuprofen in vitals sign assessments (Temperature)
Time frame: 1 hour
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Fever | 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 |
| Pain | 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 | -0.1 Degree Fahrenheit |
Primary
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.
The incidence of treatment-emergent adverse events occurring in the six hours following administration of intravenous ibuprofen.
Time frame: 6 hours
Population: This analysis was conducted on participants treated with a fever or pain indication that received only a single dose of intravenous ibuprofen
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fever | 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 |
| Pain | 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. | 16 Number of Events |
Primary
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.
The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Heart Rate).
Time frame: 1 hour
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Fever | 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 |
| Pain | 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 Beats Per Minute |
Primary
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.
The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Respiratory Rate).
Time frame: 1 hour
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Fever | 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 |
| Pain | 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 Breaths Per Minute |
Primary
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.
The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Systolic Blood Pressure).
Time frame: 1 hour
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Fever | 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 |
| Pain | 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 |
Primary
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.
The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Diastolic Blood Pressure).
Time frame: 1 hour
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Fever | 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 |
| Pain | 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. | -3 mm Hg |
Primary
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.
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) |
|---|---|---|
| Fever | 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 |
| Pain | 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 |
Secondary
To Determine the Efficacy of a Single Dose of 400 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever
The change in temperature from baseline over the 4 hours following intravenous ibuprofen administration
Time frame: 4 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Fever | 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 |
Secondary
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).
The 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.
Time frame: 4 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Fever | 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 |
Secondary
To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain
The incidence of treatment-emergent serious adverse events occurring through extended dosing.
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fever | 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 |
| Pain | To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain | 1 Number of Serious Adverse Events |
Secondary
To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain
The incidence of treatment-emergent adverse events occurring through extended dosing.
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fever | 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 |
| Pain | To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain | 14 Number of Events |