A Pilot Study Comparing the Analgesic Efficacy of IV Ibuprofen and IV Ketorolac

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).

Study Overview

• Status: Unknown
• Conditions: Chronic Pelvic Pain
• Intervention / Treatment: Drug: IV Ibuprofen; Drug: IV Ketorolac

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Culpeper, Virginia, United States, 22701
      • Culpeper Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: IV 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.; Other Names: IV Caldolor; Drug: IV 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.; Other Names: IV Toradol

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
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
Incidence of adverse events between IV ibuprofen and IV ketorolac treatment groups	One Year

Collaborators and Investigators

• Sponsor: Culpeper Surgery Center
• Collaborators: Cumberland Pharmaceuticals
• Investigators: Principal Investigator: Khalid Athar, MD, Culpeper Regional Health Systems

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: June 14, 2011
• First Submitted That Met QC Criteria: January 17, 2012
• First Posted (Estimate): January 23, 2012

Study Record Updates

• Last Update Posted (Estimate): May 16, 2012
• Last Update Submitted That Met QC Criteria: May 15, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Chronic Pelvic Pain; Ketorolac; Caldolor
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pelvic Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketorolac; Ibuprofen
• Other Study ID Numbers: KACW1