The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative hospitalized adult orthopedic patients every 6 hours for at least 24 hours is to determine the efficacy of Caldolor (IV ibuprofen) compared to placebo for the treatment of post-operative pain by patients self-assessment of pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
185
800 milligrams intravenous
Placebo comparator
Wilmax Clinical Research Inc.
Mobile, Alabama, United States
Teton Research, LLC
Little Rock, Arkansas, United States
Clinical Management Services, Inc.
Arcadia, California, United States
Southeastern Center for Clinical Trials
AUC-VAS With Movement (Post-operative Period, Hour-6-28)
Measurement of the patient's self assessment of pain with movement using the validated visual analog scale (VAS) during the post-operative period (study hour-6 through hour-28). VAS assessments document the patient's self reported level of pain from "No pain" (0 mm) to "Worst possible pain" (100 mm) on a 100 mm line. VAS assessments were performed immediately following surgery \[variable since every surgery has a unique length of time even if it is the same procedure\] and at hours 6, 8, 12, 16, 20, 24 and 28 (for the primary endpoint).
Time frame: Study hour-6 through hour-28
Secondary Endpoint: AUC-VAS at Rest (Post-operative Period, Hours 6-28)
Measurement of the patient's self assessment of pain at rest using a visual analog scale (VAS) during the post-operative period (study hour-6 through hour-28). VAS assessments document the patient's self reported level of pain from "No pain" (0 mm) to "Worst possible pain" (100 mm) on a 100 mm line. VAS assessments were performed immediately following surgery and at hours 6, 8, 12, 16, 20, 24 and 28 (for the primary endpoint).
Time frame: Study hour-6 through hour-28
Patient Demand of Narcotic Use (Post-operative Period, From Hour 6 to 28).
Patient demand of narcotic used by patients in each treatment group for analgesia, post-surgery.
Time frame: Study hour-6 to hour-28
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Atlanta, Georgia, United States
Research Concepts, Inc
Houston, Texas, United States
Research Concepts, Inc.
Houston, Texas, United States
Johannesburg General Hospital
Johannesburg, South Africa
Krugersdorp Private Hospital
Krugersdorp, South Africa
Eugene Marais Hospital
Pretoria, South Africa