Intravenous Ketorolac for Postoperative Pain in Laparoscopic Donor Nephrectomy
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00765232 |
Recruitment Status :
Completed
First Posted : October 2, 2008
Results First Posted : January 27, 2012
Last Update Posted : January 27, 2012
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Nephrectomy Laparoscopic Donor Nephrectomy | Drug: Ketorolac Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 111 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | The Efficacy of Continuous Intravenous Ketorolac for Postoperative Pain in Laparoscopic Donor Nephrectomy: a Double Blinded Randomized Placebo Controlled Trial. |
Study Start Date : | October 2008 |
Actual Primary Completion Date : | November 2010 |
Actual Study Completion Date : | November 2010 |

Arm | Intervention/treatment |
---|---|
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:
|
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. |
- Pain 'Right Now' [ Time Frame: 24 hours after the end of surgery ]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 ]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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00765232
United States, Arizona | |
Mayo Clinic | |
Phoenix, Arizona, United States, 85054 |
Principal Investigator: | Mitchell R. Humphreys, M.D. | Mayo Clinic |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Mitchell R. Humphreys, M.D., Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00765232 |
Other Study ID Numbers: |
08-000747 LDN |
First Posted: | October 2, 2008 Key Record Dates |
Results First Posted: | January 27, 2012 |
Last Update Posted: | January 27, 2012 |
Last Verified: | December 2011 |
laparoscopic donor nephrectomy |
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Ketorolac Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |