Trial | NCT01514175  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    50
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 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 Started
Jan 31
2012
Primary Completion
Dec 31
2012
Anticipated
Study Completion
Dec 31
2012
Anticipated
Last Update
May 16
2012
Estimate

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

ibuprofen versus ketoralac Experimental

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.

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
No Results Posted