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

Culpeper Surgery Center

Status and phase: Unknown; Phase 4

Conditions: Chronic Pelvic Pain

Treatments: Drug: IV Ibuprofen; Drug: IV Ketorolac

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01514175

KACW1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Triple Blind

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50 participants in 1 patient group

ibuprofen versus ketoralac

Experimental group

Description:

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.

Treatment:

Drug: IV Ketorolac

Drug: IV Ibuprofen