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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Cumberland Pharmaceuticals
Information provided by (Responsible Party):
Khalid Athar M.D., Culpeper Surgery Center
ClinicalTrials.gov Identifier:
NCT01514175
First received: June 14, 2011
Last updated: May 15, 2012
Last verified: May 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Chronic Pelvic Pain
 Drug: IV Ibuprofen
Drug: IV Ketorolac
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: A Pilot Study Comparing the Analgesic Efficacy of IV Ibuprofen and IV Ketorolac

Resource links provided by NLM:

MedlinePlus related topics: Pelvic Pain
U.S. FDA Resources

Further study details as provided by Culpeper Surgery Center:

Primary Outcome Measures:
  • 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). [ Time Frame: One Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Amount of and time to rescue medication in the postoperative period between IV ibuprofen and IV ketorolac treatment groups [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Time to mobility in the postoperative period between IV ibuprofen and IV ketorolac treatment groups [ Time Frame: One Year ] [ Designated as safety issue: No ]
  • Time to discharge in the postoperative period between IV ibuprofen and IV ketorolac treatment groups [ Time Frame: One Year ] [ Designated as safety issue: No ]
  • Incidence of adverse events between IV ibuprofen and IV ketorolac treatment groups [ Time Frame: One Year ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: January 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: IV Toradol

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514175

Locations
United States, Virginia
Culpeper Surgery Center
Culpeper, Virginia, United States, 22701
Sponsors and Collaborators
Culpeper Surgery Center
Cumberland Pharmaceuticals
Investigators
Principal Investigator: Khalid Athar, MD Culpeper Regional Health Systems
  More Information

No publications provided

Responsible Party: Khalid Athar M.D., Medical Director, Culpeper Surgery Center
ClinicalTrials.gov Identifier: NCT01514175     History of Changes
Other Study ID Numbers: KACW1
Study First Received: June 14, 2011
Last Updated: May 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Culpeper Surgery Center:
Ketorolac
Caldolor
Chronic Pelvic Pain

Additional relevant MeSH terms:
Pelvic Pain
Pain
Signs and Symptoms
Analgesics
Ibuprofen
Ketorolac
Ketorolac Tromethamine
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013