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Completed

NCT Number: NCT00765128

Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy

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.

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Key information

Conditions

Renal Calculus Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Kidney Stones Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic

Phoenix, Arizona, 85054, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketorolac

Drug

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: Toradol, Acular

Placebo

Drug

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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 2, 2008
Registry last updated
Jan 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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