Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy

Phase 4

Completed

• Conditions: Renal Calculus; Kidney Stones
• Interventions: Drug: Placebo; Drug: Ketorolac

• Registration Number: NCT00765128
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-30
• Study Start: 2008-10
• Study First Submitted QC: 2008-10-01
• Study First Posted: 2008-10-02
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Results First Submitted: 2011-11-18
• Status Verified: 2011-12
• Results First Submitted QC: 2011-12-21
• Last Update Submitted: 2011-12-21
• Results First Posted: 2012-01-27
• Last Update Posted: 2012-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Ketorolac	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.

Primary Outcome Measures

Name	Time	Method
Pain 'Right Now'	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	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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Phoenix, Arizona, United States