- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01514175
A Pilot Study Comparing the Analgesic Efficacy of IV Ibuprofen and IV Ketorolac
May 15, 2012 updated by: Khalid Athar M.D., Culpeper Surgery Center
The primary objective of this study is to compare the efficacy of a single dose of intravenous ibuprofen compared to a single dose of ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The primary objective of this study is to compare the efficacy of a single dose of intravenous ibuprofen compared to a single dose of ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS).
The secondary objectives of this study are:
- To compare amount of and time to rescue medication in the postoperative period between IV ibuprofen and IV ketorolac treatment groups.
- To compare time to mobility in the postoperative period between IV ibuprofen and IV ketorolac treatment groups.
- To compare time to discharge in the postoperative period between IV ibuprofen and IV ketorolac treatment groups.
- To compare the incidence of adverse events between IV ibuprofen and IV ketorolac treatment groups.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Virginia
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Culpeper, Virginia, United States, 22701
- Culpeper Surgery Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Patients with a preoperative diagnosis which is inclusive of chronic pelvic pain scheduled for Laparoscopic Surgery
Exclusion Criteria:
- Inadequate IV access.
- History of allergy or hypersensitivity to any component of IVIb,ketorolac, aspirin (or aspirin related products), NSAIDs, or COX-2 inhibitors.
- Less than 18 years of age or Greater than 65 years of age.
- Use of analgesics, including NSAIDs, less than 12 hours prior to surgery.
- Patients with active, clinically significant anemia.
- History or evidence of asthma or heart failure.
- Pregnant.
- 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.
- Patients with a history of Chronic Pain Conditions or Syndromes excluding patients with Chronic Pelvic Pain.
- Patients with known OSA
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: ibuprofen versus ketoralac
IV ibuprofen (800 mg intravenous ibuprofen administered intravenously over 10 minutes) will be administered as a single dose prior to surgery at the initiation of anesthesia.
A corresponding volume of NS will be administered to the group randomized to ketorolac, at the same time to maintain the study blind.
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Patients will be randomized to receive 800 mg intravenous ibuprofen or 30 mg ketorolac; each of the two treatment groups will consist of 25 patients.
Other Names:
Patients will be randomized to receive 800 mg intravenous ibuprofen or 30 mg ketorolac; each of the two treatment groups will consist of 25 patients.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The efficacy of a single dose of intravenous ibuprofen compared to a single dose of ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS).
Time Frame: One Year
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One Year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Amount of and time to rescue medication in the postoperative period between IV ibuprofen and IV ketorolac treatment groups
Time Frame: 1 Year
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1 Year
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Time to mobility in the postoperative period between IV ibuprofen and IV ketorolac treatment groups
Time Frame: One Year
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One Year
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Time to discharge in the postoperative period between IV ibuprofen and IV ketorolac treatment groups
Time Frame: One Year
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One Year
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Incidence of adverse events between IV ibuprofen and IV ketorolac treatment groups
Time Frame: One Year
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One Year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Khalid Athar, MD, Culpeper Regional Health Systems
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Anticipated)
December 1, 2012
Study Completion (Anticipated)
December 1, 2012
Study Registration Dates
First Submitted
June 14, 2011
First Submitted That Met QC Criteria
January 17, 2012
First Posted (Estimate)
January 23, 2012
Study Record Updates
Last Update Posted (Estimate)
May 16, 2012
Last Update Submitted That Met QC Criteria
May 15, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Pelvic Pain
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Ketorolac
- Ibuprofen
Other Study ID Numbers
- KACW1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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