Phase 4 N=150 Treatment

Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen

Pain · Fever

Bottom Line

View on ClinicalTrials.gov: NCT01334944 ↗

Enrolled (actual)

150

Serious AEs

0.7%

Results posted

Jun 2014

Primary outcome: 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; 0 Number of Serious Adverse Events

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Intravenous ibuprofen (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Cumberland Pharmaceuticals
Primary completion: Sep 2012

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.	-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	—
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.	-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.	-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.	-4; -3	—
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	—
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	—

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.

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

View full record on ClinicalTrials.gov →

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.