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Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00765128
First received: September 30, 2008
Last updated: December 21, 2011
Last verified: December 2011
  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.


Condition Intervention Phase
Renal Calculus
Kidney Stones
Drug: Ketorolac
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Continuous Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy: a Double Blinded Randomized Placebo Controlled Trial

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

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.


Enrollment: 17
Study Start Date: October 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765128

Locations
United States, Arizona
Mayo Clinic
Phoenix, Arizona, United States, 85054
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Mitchell R. Humphreys, M.D. Mayo Clinic
  More Information

Additional Information:
No publications provided by Mayo Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mitchell R. Humphreys, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00765128     History of Changes
Other Study ID Numbers: 08-000747 PNL
Study First Received: September 30, 2008
Results First Received: November 18, 2011
Last Updated: December 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Percutaneous
Nephrolithotomy
Kidney stones

Additional relevant MeSH terms:
Kidney Calculi
Nephrolithiasis
Pain, Postoperative
Calculi
Kidney Diseases
Pain
Pathologic Processes
Pathological Conditions, Anatomical
Postoperative Complications
Signs and Symptoms
Urinary Calculi
Urolithiasis
Urologic Diseases
Ketorolac
Ketorolac Tromethamine
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014