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

NCT ID: NCT01514175

Last Updated: 2012-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-12-31

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.

Conditions

Chronic Pelvic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

IV Ibuprofen

Intervention Type: DRUG

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.

IV Ketorolac

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

IV Caldolor; IV Toradol

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cumberland Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Culpeper Surgery Center

OTHER

Sponsor Role: lead

Responsible Party

Khalid Athar M.D.

Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Khalid Athar, MD

Role: PRINCIPAL_INVESTIGATOR

Culpeper Regional Health Systems

Locations

Culpeper Surgery Center

Culpeper, Virginia, United States

Countries

United States

Other Identifiers

KACW1

Identifier Type: -

Identifier Source: org_study_id