A Pilot Study Comparing the Analgesic Efficacy of IV Ibuprofen and IV Ketorolac
Overview
- Phase
- Phase 4
- Intervention
- IV Ibuprofen
- Conditions
- Chronic Pelvic Pain
- Sponsor
- Culpeper Surgery Center
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- 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).
- Last Updated
- 13 years ago
Overview
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 patient pain intensity (Visual Analog Scale, VAS).
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.
Investigators
Khalid Athar M.D.
Medical Director
Culpeper Surgery Center
Eligibility Criteria
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.
Arms & Interventions
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.
Intervention: IV Ibuprofen
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.
Intervention: IV Ketorolac
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Incidence of adverse events between IV ibuprofen and IV ketorolac treatment groups(One Year)
- Amount of and time to rescue medication in the postoperative period between IV ibuprofen and IV ketorolac treatment groups(1 Year)
- Time to mobility in the postoperative period between IV ibuprofen and IV ketorolac treatment groups(One Year)
- Time to discharge in the postoperative period between IV ibuprofen and IV ketorolac treatment groups(One Year)