Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy

Overview[ - collapse ][ - ]

Purpose The purpose of this study is to determine whether continuous intravenous ketorolac infusion reduces pain in patients who are having percutaneous nephrolithotomy for kidney stone disease.
ConditionRenal Calculus
Kidney Stones
InterventionDrug: Ketorolac
Drug: Placebo
PhasePhase 4
SponsorMayo Clinic
Responsible PartyMayo Clinic
ClinicalTrials.gov IdentifierNCT00765128
First ReceivedSeptember 30, 2008
Last UpdatedDecember 21, 2011
Last verifiedDecember 2011

Tracking Information[ + expand ][ + ]

First Received DateSeptember 30, 2008
Last Updated DateDecember 21, 2011
Start DateOctober 2008
Estimated Primary Completion DateNovember 2010
Current Primary Outcome Measures
  • 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.
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleIntravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy
Official TitleThe Efficacy of Continuous Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy: 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 percutaneous nephrolithotomy for kidney stone
disease.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition
  • Renal Calculus
  • Kidney Stones
InterventionDrug: 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 Arm (s)
  • 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.
  • 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.

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment17
Estimated Completion DateNovember 2010
Estimated Primary Completion DateNovember 2010
Eligibility Criteria
Inclusion Criteria:

- Patients undergoing percutaneous nephrolithotomy for kidney stone disease

Exclusion Criteria:

- History of nonsteroidal antiinflammatory drug 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 (Creatinine > 2.0 mg/dL)

- Bleeding diathesis

- Current use of probenecid

- Pregnancy
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00765128
Other Study ID Numbers08-000747 PNL
Has Data Monitoring CommitteeNo
Information Provided ByMayo Clinic
Study SponsorMayo Clinic
CollaboratorsNot Provided
Investigators Principal Investigator: Mitchell R. Humphreys, M.D. Mayo Clinic
Verification DateDecember 2011

Locations[ + expand ][ + ]

Mayo Clinic
Phoenix, Arizona, United States, 85054