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| Sponsored by: |
Mayo Clinic |
|---|---|
| Information provided by: | Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00765128 |
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 |
|---|---|---|
|
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 |
|---|---|
|
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.
|
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.
|
|
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.
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| 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 |
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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 |
