Chronic Pelvic Pain
Conditions
Keywords
Ketorolac, Caldolor, Chronic Pelvic Pain
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.
Interventions
DRUGIV Ibuprofen
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.
DRUGIV Ketorolac
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.
Sponsors
Cumberland Pharmaceuticals
Culpeper Surgery Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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). | One Year |
Secondary
| Measure | Time frame |
|---|---|
| Time to mobility in the postoperative period 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 discharge in the postoperative period between IV ibuprofen and IV ketorolac treatment groups | One Year |
| Incidence of adverse events between IV ibuprofen and IV ketorolac treatment groups | One Year |
Countries
United States
Outcome results
None listed