Status:
UNKNOWN
A Pilot Study Comparing the Analgesic Efficacy of IV Ibuprofen and IV Ketorolac
Lead Sponsor:
Culpeper Surgery Center
Collaborating Sponsors:
Cumberland Pharmaceuticals
Conditions:
Chronic Pelvic Pain
Eligibility:
FEMALE
18-65 years
Phase:
PHASE4
Brief Summary
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 p...
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 p...
Eligibility Criteria
Inclusion
- Patients with a preoperative diagnosis which is inclusive of chronic pelvic pain scheduled for Laparoscopic Surgery
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01514175
Start Date
January 1 2012
End Date
December 1 2012
Last Update
May 16 2012
Active Locations (1)
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1
Culpeper Surgery Center
Culpeper, Virginia, United States, 22701