NCT00765128

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2008

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2008

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 27, 2012

Completed
Last Updated

January 27, 2012

Status Verified

December 1, 2011

Enrollment Period

2.1 years

First QC Date

September 30, 2008

Results QC Date

November 18, 2011

Last Update Submit

December 21, 2011

Conditions

Renal CalculusKidney Stones

Keywords

PercutaneousNephrolithotomyKidney stones

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

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

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

Interventions

KetorolacDRUG

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.

Also known as: Toradol, Acular
Ketorolac
PlaceboDRUG

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing percutaneous nephrolithotomy for kidney stone disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

Related Publications (2)

  • 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.

    PMID: 24976224DERIVED

  • 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.

    PMID: 23058854DERIVED

MeSH Terms

Conditions

Kidney Calculi

Interventions

KetorolacKetorolac Tromethamine

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Mitchell R. Humphreys MD
Organization
Mayo Clinic
humphreys.mitchell@mayo.edu
480-301-8000

Study Officials

  • Mitchell R. Humphreys, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 30, 2008

First Posted

October 2, 2008

Study Start

October 1, 2008

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

January 27, 2012

Results First Posted

January 27, 2012

Record last verified: 2011-12

Locations

US(1)