Intravenous Ketorolac for Postoperative Pain in Laparoscopic Donor Nephrectomy

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00765232
First received: September 30, 2008
Last updated: December 21, 2011
Last verified: December 2011

September 30, 2008
December 21, 2011
October 2008
November 2010   (final data collection date for primary outcome measure)
  • Pain 'Right Now' [ Time Frame: 24 hours after the end of surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • Pain 'right now' [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Morphine equivalents of concomitant pain medication [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00765232 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Intravenous Ketorolac for Postoperative Pain in Laparoscopic Donor Nephrectomy
The Efficacy of Continuous Intravenous Ketorolac for Postoperative Pain in Laparoscopic Donor Nephrectomy: a Double Blinded Randomized Placebo Controlled Trial.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Nephrectomy
  • Laparoscopic Donor Nephrectomy
  • 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.
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
111
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00765232
08-000747 LDN
No
Mitchell R. Humphreys, M.D., Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Mitchell R. Humphreys, M.D. Mayo Clinic
Mayo Clinic
December 2011

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