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NCT00765128 Clinical Trial

Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy

Kidney Stones Clinical Trial

Official title:
The Efficacy of Continuous Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy: a Double Blinded Randomized Placebo Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00765128
Other study ID # 08-000747 PNL
Secondary ID
Status Completed
Phase Phase 4
First received September 30, 2008
Last updated December 21, 2011
Start date October 2008
Est. completion date November 2010

Study information
Verified date December 2011
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 17
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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
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.

Locations
Country Name City State
United States Mayo Clinic Phoenix Arizona

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain 'Right Now' Visual analog scale score for pain on a scale from 0 = None to 10 = Worst. 24 hours after the end of surgery No
Primary Morphine Equivalents of Concomitant Pain Medication 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. 24 hours after the end of surgery No
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Recruiting NCT00489723 - Is There is a Role of Prophylactic Therapy With Tamsulosin Before Extracorporeal Shock Wave Lithotripsy to Avoid Development of Steinstrasse ? N/A
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Enrolling by invitation NCT02408211 - Preoperative Antibiotic PNL Study Phase 4
Withdrawn NCT01560091 - Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After Extra-corporeal Shock Wave Lithotripsy Phase 3
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