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Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy

Primary Purpose

Renal Calculus, Kidney Stones

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketorolac
Placebo
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Calculus focused on measuring Percutaneous, Nephrolithotomy, Kidney stones

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ketorolac

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain 'Right Now'
Visual analog scale score for pain on a scale from 0 = None to 10 = Worst.
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.

Secondary Outcome Measures

Full Information

First Posted
September 30, 2008
Last Updated
December 21, 2011
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00765128
Brief Title
Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy
Official Title
The Efficacy of Continuous Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy: a Double Blinded Randomized Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Calculus, Kidney Stones
Keywords
Percutaneous, Nephrolithotomy, Kidney stones

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketorolac
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Toradol, Acular
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Pain 'Right Now'
Description
Visual analog scale score for pain on a scale from 0 = None to 10 = Worst.
Time Frame
24 hours after the end of surgery
Title
Morphine Equivalents of Concomitant Pain Medication
Description
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.
Time Frame
24 hours after the end of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell R. Humphreys, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24976224
Citation
Grimsby GM, Andrews PE, Castle EP, Nunez R, Mihalik LA, Chang YH, Humphreys MR. Long-term renal function after donor nephrectomy: secondary follow-up analysis of the randomized trial of ketorolac vs placebo. Urology. 2014 Jul;84(1):78-81. doi: 10.1016/j.urology.2014.04.009.
Results Reference
derived
PubMed Identifier
23058854
Citation
Grimsby GM, Conley SP, Trentman TL, Castle EP, Andrews PE, Mihalik LA, Hentz JG, Humphreys MR. A double-blind randomized controlled trial of continuous intravenous Ketorolac vs placebo for adjuvant pain control after renal surgery. Mayo Clin Proc. 2012 Nov;87(11):1089-97. doi: 10.1016/j.mayocp.2012.07.018. Epub 2012 Oct 8.
Results Reference
derived
Links:
URL
http://clinicaltrials.mayo.edu
Description
Mayo Clinic Clinical Trials

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Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy

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