Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intravenous Ketorolac for Postoperative Pain in Laparoscopic Donor Nephrectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00765232
Recruitment Status : Completed
First Posted : October 2, 2008
Results First Posted : January 27, 2012
Last Update Posted : January 27, 2012
Sponsor:
Information provided by:
Mayo Clinic

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to determine whether continuous intravenous ketorolac infusion reduces pain in patients who are having laparoscopic surgery to donate a kidney.

Condition or disease Intervention/treatment Phase
Nephrectomy Laparoscopic Donor Nephrectomy Drug: Ketorolac Drug: Placebo Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Continuous Intravenous Ketorolac for Postoperative Pain in Laparoscopic Donor Nephrectomy: a Double Blinded Randomized Placebo Controlled Trial.
Study Start Date : October 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Organ Donation
Drug Information available for: Ketorolac

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Ketorolac
90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
 Drug: Ketorolac
90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
Other Names:
  • Toradol
  • Acular
Placebo Comparator: Placebo
1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
 Drug: Placebo
1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Pain 'Right Now' [ Time Frame: 24 hours after the end of surgery ]
    Visual analog scale score for pain on a scale from 0 = None to 10 = Worst.

  2. Morphine Equivalents of Concomitant Pain Medication [ Time Frame: 24 hours after the end of surgery ]
    The morphine equivalent is a unit of measure to compare the efficacy of different types of opioids (narcotics). The patients were allowed to take additional pain medication in addition to either study drug or placebo. This outcome measure reports the amount of morphine (in mg) equivalent to the amount of concomitant pain medication used by the patient.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients donating a kidney via laparoscopic donor nephrectomy

Exclusion Criteria:

  • History of NSAID allergy
  • Asthma
  • History of long term opioid use
  • Intraoperative blood loss greater than 300 mL
  • Postoperative hemodynamic instability
  • Active peptic ulcer disease
  • Advanced renal impairment (Cr > 2.0 mg/dL)
  • Bleeding diathesis
  • Current use of probenecid
  • Pregnancy
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00765232


Locations
Layout table for location information
United States, Arizona
Mayo Clinic
Phoenix, Arizona, United States, 85054
Sponsors and Collaborators
Mayo Clinic
Investigators
Layout table for investigator information
Principal Investigator: Mitchell R. Humphreys, M.D. Mayo Clinic
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Mitchell R. Humphreys, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00765232    
Other Study ID Numbers: 08-000747 LDN
First Posted: October 2, 2008    Key Record Dates
Results First Posted: January 27, 2012
Last Update Posted: January 27, 2012
Last Verified: December 2011
Keywords provided by Mayo Clinic:
laparoscopic
donor
nephrectomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Ketorolac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action