Back to resultsA Pilot Study Comparing the Analgesic Efficacy of IV Ibuprofen and IV Ketorolac
Primary Purpose
Chronic Pelvic Pain
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
IV Ibuprofen
IV Ketorolac
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Pelvic Pain focused on measuring Ketorolac, Caldolor, Chronic Pelvic Pain
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.
- Patients with known OSA
Sites / Locations
- Culpeper Surgery Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ibuprofen versus ketoralac
Arm Description
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Amount of and time to rescue medication in the postoperative period between IV ibuprofen and IV ketorolac treatment groups
Time to mobility in the postoperative period between IV ibuprofen and IV ketorolac treatment groups
Time to discharge in the postoperative period between IV ibuprofen and IV ketorolac treatment groups
Incidence of adverse events between IV ibuprofen and IV ketorolac treatment groups
Full Information
NCT ID
NCT01514175
First Posted
June 14, 2011
Last Updated
May 15, 2012
Sponsor
Culpeper Surgery Center
Collaborators
Cumberland Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01514175
Brief Title
A Pilot Study Comparing the Analgesic Efficacy of IV Ibuprofen and IV Ketorolac
Official Title
A Pilot Study Comparing the Analgesic Efficacy of IV Ibuprofen and IV Ketorolac
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Culpeper Surgery Center
Collaborators
Cumberland Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pelvic Pain
Keywords
Ketorolac, Caldolor, Chronic Pelvic Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ibuprofen versus ketoralac
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
IV Ibuprofen
Other Intervention Name(s)
IV Caldolor
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
IV Ketorolac
Other Intervention Name(s)
IV Toradol
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Amount of and time to rescue medication in the postoperative period between IV ibuprofen and IV ketorolac treatment groups
Time Frame
1 Year
Title
Time to mobility in the postoperative period between IV ibuprofen and IV ketorolac treatment groups
Time Frame
One Year
Title
Time to discharge in the postoperative period between IV ibuprofen and IV ketorolac treatment groups
Time Frame
One Year
Title
Incidence of adverse events between IV ibuprofen and IV ketorolac treatment groups
Time Frame
One Year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Patients with known OSA
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khalid Athar, MD
Organizational Affiliation
Culpeper Regional Health Systems
Official's Role
Principal Investigator
Facility Information:
Facility Name
Culpeper Surgery Center
City
Culpeper
State/Province
Virginia
ZIP/Postal Code
22701
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study Comparing the Analgesic Efficacy of IV Ibuprofen and IV Ketorolac
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