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Sponsored by: |
Mayo Clinic |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00765128 |
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 |
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Percutaneous Nephrolithotomy Kidney Stones |
Drug: Ketorolac Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | The Efficacy of Continuous Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy: a Double Blinded Randomized Placebo Controlled Trial |
Estimated Enrollment: | 80 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Ketorolac: Experimental
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.
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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.
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Placebo: Placebo Comparator
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.
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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.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Christine A. Moffat | 480-342-3096 | moffat.christine@mayo.edu |
United States, Arizona | |
Mayo Clinic | |
Phoenix, Arizona, United States, 85054 |
Principal Investigator: | Mitchell R. Humphreys, M.D. | Mayo Clinic |
Responsible Party: | Mayo Clinic ( Mitchell R. Humphreys, M.D. ) |
Study ID Numbers: | 08-000747 PNL, 08-000747 PNL |
Study First Received: | September 30, 2008 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00765128 |
Health Authority: | United States: Institutional Review Board |
Percutaneous Nephrolithotomy Kidney Stones |
Pathological Conditions, Anatomical Urinary Calculi Urolithiasis Ketorolac Pain Calculi Signs and Symptoms |
Urologic Diseases Postoperative Complications Kidney Diseases Ketorolac Tromethamine Nephrolithiasis Kidney Calculi Pain, Postoperative |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Pharmacologic Actions Pathologic Processes Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |