Kidney Stones, Renal Calculus
Conditions
Keywords
Percutaneous, Nephrolithotomy, Kidney stones
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.
Interventions
DRUGKetorolac
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.
DRUGPlacebo
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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from October 2008 to November 2010.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| 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. | 9 |
| Total | 17 |
Baseline characteristics
| Characteristic | Ketorolac | Placebo | Total |
|---|---|---|---|
| Age Continuous | 59.0 years STANDARD_DEVIATION 8 | 62.0 years STANDARD_DEVIATION 9.8 | 60.6 years STANDARD_DEVIATION 9 |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 8 | 8 / 9 |
| serious Total, serious adverse events | 0 / 8 | 0 / 9 |
Outcome results
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.
Time frame: 24 hours after the end of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | Morphine Equivalents of Concomitant Pain Medication | 15 mg | Standard Deviation 33 |
| Placebo | Morphine Equivalents of Concomitant Pain Medication | 10 mg | Standard Deviation 14 |
Primary
Pain 'Right Now'
Visual analog scale score for pain on a scale from 0 = None to 10 = Worst.
Time frame: 24 hours after the end of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | Pain 'Right Now' | 1.0 units on a scale | Standard Deviation 1.2 |
| Placebo | Pain 'Right Now' | 0.9 units on a scale | Standard Deviation 1.5 |