Phase 4
Completed N=150
Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen
Source: ClinicalTrials.gov NCT01334944 ↗Enrolled (actual)
150
Serious AEs
0.7%
Results posted
Jun 2014
Primary outcomePrimary: 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; 0 Number of Serious Adverse Events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
-4; -3 | — |
| 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 |
-0.9; -0.1 | — |
| SECONDARY 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 | — |
| 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). |
-27.1 | — |
| SECONDARY To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain |
0; 14 | — |
Eligibility Criteria
Inclusion Criteria
- Pain: Patients with baseline Visual Analog Scale assessment >3, -and/or- Fever: Patients with temperature >101°F.
Exclusion Criteria
- Patients with inadequate IV access
- Patients <18 years of age
- History or allergy or hypersensitivity to any component of intravenous ibuprofen, aspirin (or aspirin related products) or non-steroidal anti-inflammatory drug (NSAIDs)
- Active hemorrhage or clinically significant bleeding
- Pregnant or nursing
- Patients in the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery
- 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
- Refusal to provide written authorization for use and disclosure of protected health information
Data sourced from ClinicalTrials.gov (NCT01334944). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.