A Pilot Study Comparing the Analgesic Efficacy of IV Ibuprofen and IV Ketorolac
Information source: Culpeper Surgery Center
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Pelvic Pain
Intervention: IV Ibuprofen (Drug); IV Ketorolac (Drug)
Phase: Phase 4
Status: Enrolling by invitation
Sponsored by: Culpeper Surgery Center Official(s) and/or principal investigator(s):
Khalid Athar, MD, Principal Investigator, Affiliation: Culpeper Regional Health Systems
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).
Clinical Details
Official title: A Pilot Study Comparing the Analgesic Efficacy of IV Ibuprofen and IV Ketorolac
Study design: Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Primary outcome: 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: Amount of and time to rescue medication in the postoperative period between IV ibuprofen and IV ketorolac treatment groupsTime 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
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Female.
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
Locations and Contacts
Culpeper Surgery Center, Culpeper, Virginia 22701, United States
Additional Information
Starting date: January 2012
Last updated: May 15, 2012
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