Clinical trial NCT01514175: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Pelvic Pain
Keywords: Ketorolac
Caldolor
Chronic Pelvic Pain
Lead sponsor: Culpeper Surgery Center
Sponsor class: OTHER
Collaborators: name: Cumberland Pharmaceuticals
First posted: 2012-01-23
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: 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).
timeFrame: One Year
Secondary outcomes:
measure: Amount of and time to rescue medication in the postoperative period between IV ibuprofen and IV ketorolac treatment groups
timeFrame: 1 Year
measure: Time to mobility in the postoperative period between IV ibuprofen and IV ketorolac treatment groups
timeFrame: One Year
measure: Time to discharge in the postoperative period between IV ibuprofen and IV ketorolac treatment groups
timeFrame: One Year
measure: Incidence of adverse events between IV ibuprofen and IV ketorolac treatment groups
timeFrame: One Year
Other outcomes:
Locations:
city: Culpeper
country: United States
facility: Culpeper Surgery Center
state: Virginia
Study officials:
affiliation: Culpeper Regional Health Systems
name: Khalid Athar, MD
role: PRINCIPAL_INVESTIGATOR
References: