Efficacy and Safety Study of Caldolor (IV Ibuprofen) in Hospitalized Adult Orthopedic Patients
This study has been completed.
Information provided by (Responsible Party):
First received: May 7, 2007
Last updated: August 3, 2015
Last verified: August 2015
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.
Other: Normal Saline
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF IBUPROFEN INJECTION (IVIb) FOR TREATMENT OF PAIN IN POST-OPERATIVE ORTHOPEDIC ADULT PATIENTS
Primary Outcome Measures:
- AUC-VAS With Movement (Post-operative Period, Hour-6-28) [ Time Frame: Study hour-6 through hour-28 ] [ Designated as safety issue: No ]
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).
Secondary Outcome Measures:
- Secondary Endpoint: AUC-VAS at Rest (Post-operative Period, Hours 6-28) [ Time Frame: Study hour-6 through hour-28 ] [ Designated as safety issue: No ]
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).
- Patient Demand of Narcotic Use (Post-operative Period, From Hour 6 to 28). [ Time Frame: Study hour-6 to hour-28 ] [ Designated as safety issue: No ]
Patient demand of narcotic used by patients in each treatment group for analgesia, post-surgery.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2008 (Final data collection date for primary outcome measure)
Placebo Comparator: Normal Saline
250 milliliters normal saline as a placebo comparator was administered every 6 hours for a total of five doses over the first 24 hours. Those patients who received the initial five doses could continue to receive additional doses as needed every 6 hours through the 120-hour treatment period.
Other: Normal Saline
Other Name: NS
Experimental: Intravenous ibuprofen
800 mg of intravenous ibuprofen diluted in 250 milliliters normal saline was administered every 6 hours for a total of five doses over the first 24 hours. Those patients who received the initial five doses could continue to receive additional doses as needed every 6 hours through the 120-hour treatment period.
800 milligrams intravenous
Other Name: Ibuprofen
|Ages Eligible for Study:
||18 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Scheduled for elective hip or knee replacement, reconstruction or arthroplasty surgery with anticipated need for post-operative intravenous (IV) morphine analgesia with anticipated use of (greater than or equal to (≥) 28 hours.
- Adequate IV access
- Anticipated hospital stay ≥ 28 hours
- Be unable to make a reliable self-report of pain intensity to pain relief
- Less than 18 years of age
- Greater than 80 years of age
- Use of analgesics, muscle relaxants, NSAIDS and sedatives less than 12 hours prior to clinicaltrial material(CTM) administration with the following exceptions: paracetamol (acetaminophen) can be administered until 6 hours prior to surgery; tramadol can be administered until midnight the evening prior to surgery; muscle relaxants working at the neuromuscular junction used for intubation and/or anesthesia administration for the surgical procedure prior to CTM administration; and sedatives (i.e., midazolam) used as a co-induction agent for the surgical procedure prior to CTM administration
- Patients taking warfarin, lithium, combination of angiotension converting enzyme(ACE)-inhibitors and furosemide
- Patients with anemia (active, clinically significant anemia) and/or a history or evidence of asthma or heart failure
- History of allergy or hypersensitivity to any component of Caldolor, aspirin (or aspirin related products), NSAIDs, or COX-2 inhibitors
- Pregnant or nursing
- History of severe head trauma that required current hospitalization, intracranial surgery or stroke within the previous 30 days, or any history of intracerebral arteriovenous malformation, cerebral aneurysm or CNS mass lesion
- Weigh less than 30 kilogram
- Have a history of congenital bleeding diathesis (e.g. hemophilia) or any active clinically significant bleeding, or have underlying platelet dysfunction including (but not limited to) idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, or congenital platelet dysfunction
- Have gastrointestional (GI) bleeding that required medical intervention within the previous 6 weeks (unless definitive surgery has been performed)
- Have a platelet count less than 30,000 mm^3 determined within the 28 days prior to surgery
- Pre-existing dependence on narcotics or known tolerance to opioids
- 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 and to return for the required assessments
- Refusal to provide written authorization for use and disclosure of protected health information
- Be on dialysis, have oliguria or creatinine greater than 3.0 milligram/deciliter.
- Inability to achieve hemostasis or inability to close surgical incision, prior to Operating Room discharge
- Operative procedure includes organ transplant
- Pre or intra-operative procedure utilized for the prevention of pre- or post-operative pain (i.e. epidural or nerve blocks)
- Be receiving full dose anticoagulation therapy or Activated Protein C within 6 hours before dosing (Prophylaxis with subcutaneous heparin is acceptable)
- Have received another investigational drug within the past 30 days
- Be otherwise unsuitable for the study in the opinion of the investigator
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00470600
|Wilmax Clinical Research Inc.
|Mobile, Alabama, United States, 336608 |
|Teton Research, LLC
|Little Rock, Arkansas, United States, 72205 |
|Clinical Management Services, Inc.
|Arcadia, California, United States, 91007 |
|Southeastern Center for Clinical Trials
|Atlanta, Georgia, United States, 30350 |
|Research Concepts, Inc
|Houston, Texas, United States, 77054 |
|Research Concepts, Inc.
|Houston, Texas, United States, 77401 |
|Johannesburg General Hospital
|Johannesburg, South Africa |
|Krugersdorp Private Hospital
|Krugersdorp, South Africa |
|Eugene Marais Hospital
|Pretoria, South Africa |
||Neil Singla, MD
||Lotus Clinical Research/Methodist Hospital of Southern CA
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 7, 2007
|Results First Received:
||April 7, 2011
||August 3, 2015
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 08, 2015
Anti-Inflammatory Agents, Non-Steroidal
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents