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Trial record 70 of 465 for:    KETOROLAC

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

Tracking Information
First Submitted Date  ICMJE September 30, 2008
First Posted Date  ICMJE October 2, 2008
Results First Submitted Date  ICMJE November 18, 2011
Results First Posted Date  ICMJE January 27, 2012
Last Update Posted Date January 27, 2012
Study Start Date  ICMJE October 2008
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2011)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 1, 2008)
  • Pain 'Right Now' [ Time Frame: 24 hours ]
  • Morphine Equivalents of Concomitant Pain Medication [ Time Frame: 24 hours ]
Change History Complete list of historical versions of study NCT00765232 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous Ketorolac for Postoperative Pain in Laparoscopic Donor Nephrectomy
Official Title  ICMJE The Efficacy of Continuous Intravenous Ketorolac for Postoperative Pain in Laparoscopic Donor Nephrectomy: a Double Blinded Randomized Placebo Controlled Trial.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Nephrectomy
  • Laparoscopic Donor Nephrectomy
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Ketorolac
  • 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.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2011)
111
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2008)
80
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00765232
Other Study ID Numbers  ICMJE 08-000747 LDN
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mitchell R. Humphreys, M.D., Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mitchell R. Humphreys, M.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP