Kidney Calculi, Ureteral Calculi
Conditions
Brief summary
A double blind randomized controlled trial designed to compare pain control and safety with ketorolac and oxycodone in the post-operative setting for patients undergoing ureteroscopy for treatment of urinary stones. Patients are followed for five days after their surgery as they record their pain scores, medication utilization, and stent related symptoms.
Detailed description
Pain is the leading cause for unplanned emergency department visits and readmissions after ureteroscopy (URS), making post-operative analgesic stewardship a priority given the current opioid epidemic. The investigators conducted a double-blinded, randomized controlled trial (RCT), with non-inferiority design, comparing nonsteroidal anti-inflammatory drugs (NSAIDs) to opiates for postoperative pain control in patients undergoing URS for urolithiasis. Patients were randomized and blinded to either oxycodone (5mg) or ketorolac (10mg), taken as needed, with 3 non-blinded oxycodone rescue pills for breakthrough pain. Primary study outcome was visual analog scale pain score on post-operative days 1-5. Secondary outcomes included medication utilization, side effects, and Ureteral Stent Symptoms Questionnaire (USSQ) scores.
Interventions
DRUGOxycodone
5 mg of oxycodone taken by mouth every 6 hours for 5 days
DRUGKetorolac
10 mg of ketorolac taken by mouth every 6 hours for 5 days
Sponsors
The Cleveland 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 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients with kidney or ureteral stones confirmed on imaging (CT of the abdomen pelvis) and who elect for definitive treatment via unilateral ureteroscopy at one of two hospital sites within a tertiary care institution * Patients who post-operatively receive a unilateral ureteral stent * Capable of giving informed consent * Capable and willing to fulfill requirements of the study
Exclusion criteria
* Active or history of peptic ulcer disease, gastrointestinal bleeding or perforation * History of coronary artery bypass graft surgery * History of a bleeding disorder * GFR less than 60 mL/min/1.73m2 (MDRD equation) * Chronic use of opioid or other pain medication including NSAIDs (greater than 12 weeks) * Known allergy to either ketorolac or oxycodone * Known or suspected pregnancy * Solitary kidney * Patients taking anticoagulant medication or antiplatelet medication (e.g. warfarin, clopidogrel, pradaxa, rivaroxaban, apixaban etc). * Inability to give informed consent or unable to meet requirements of the study for any reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Pain Score | 5 days | Patient Reported Visual Analogue Score scored from 0-10 with lower scores equaling less pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of Rescue Medication (Opioid) | post operative day 1-5 | the use of rescue opioid medication as per the study protocol; use of rescue medication by the patients |
| Number of Study Pills Used | Post-operative days 1 to 5 | the use of opioid medication as per the study protocol; Required study pills |
Other
| Measure | Time frame | Description |
|---|---|---|
| Day in Bed | 5 days | number of days patient spent confined to bed post operatively |
| Visual Analogue Scale (VAS) | Up to 5 days | VAS as reported by the patients while in PACU (score from 0-10, with 0 meaning no pain and 10 max pain) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oxycodone Group Patients randomized to 20 pills of 5 mg oxycodone by mouth every 6 hours as needed for pain after ureteroscopy.
Oxycodone: 5 mg of oxycodone taken by mouth every 6 hours for 5 days | 43 |
| Ketorolac Group Patients randomized to 20 pills of 10 mg ketorolac by mouth every 6 hours as needed for pain after ureteroscopy.
Ketorolac: 10 mg of ketorolac taken by mouth every 6 hours for 5 days | 38 |
| Total | 81 |
Baseline characteristics
| Characteristic | Oxycodone Group | Ketorolac Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants | 38 Participants | 81 Participants |
| Age, Continuous | 51.2 years STANDARD_DEVIATION 14 | 53.8 years STANDARD_DEVIATION 12.4 | 52.4 years STANDARD_DEVIATION 13.3 |
| Race/Ethnicity, Customized Caucasian | 38 Participants | 33 Participants | 71 Participants |
| Race/Ethnicity, Customized Non Caucasian | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Female | 24 Participants | 16 Participants | 40 Participants |
| Sex: Female, Male Male | 19 Participants | 22 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 38 |
| other Total, other adverse events | 12 / 43 | 11 / 38 |
| serious Total, serious adverse events | 0 / 43 | 0 / 38 |
Outcome results
Primary
Visual Analog Pain Score
Patient Reported Visual Analogue Score scored from 0-10 with lower scores equaling less pain.
Time frame: 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxycodone Group | Visual Analog Pain Score | 4.6 units on a scale | Standard Deviation 3.1 |
| Ketorolac Group | Visual Analog Pain Score | 4.5 units on a scale | Standard Deviation 2.9 |
Secondary
Number of Study Pills Used
the use of opioid medication as per the study protocol; Required study pills
Time frame: Post-operative days 1 to 5
Population: 5 patients in the Oxy group and 2 in the Ketorolac group didn't require meds so they were excluded from final calculation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxycodone Group | Number of Study Pills Used | 7.3 number of pills used | Standard Deviation 6.1 |
| Ketorolac Group | Number of Study Pills Used | 7.1 number of pills used | Standard Deviation 5.2 |
Secondary
Use of Rescue Medication (Opioid)
the use of rescue opioid medication as per the study protocol; use of rescue medication by the patients
Time frame: post operative day 1-5
Population: not all enrolled subjects used rescue medications
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxycodone Group | Use of Rescue Medication (Opioid) | 1.1 number of pills used | Standard Deviation 1.3 |
| Ketorolac Group | Use of Rescue Medication (Opioid) | 0.8 number of pills used | Standard Deviation 1.2 |
Other Pre-specified
Day in Bed
number of days patient spent confined to bed post operatively
Time frame: 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxycodone Group | Day in Bed | 2.3 days | Standard Deviation 2.6 |
| Ketorolac Group | Day in Bed | 1 days | Standard Deviation 1.3 |
Other Pre-specified
Visual Analogue Scale (VAS)
VAS as reported by the patients while in PACU (score from 0-10, with 0 meaning no pain and 10 max pain)
Time frame: Up to 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxycodone Group | Visual Analogue Scale (VAS) | 4.6 units on a scale | Standard Deviation 3.1 |
| Ketorolac Group | Visual Analogue Scale (VAS) | 4.5 units on a scale | Standard Deviation 2.9 |