Back to resultsStudy of Ketorolac Versus Opioid for Pain After Endoscopy (SKOPE)
Primary Purpose
Kidney Calculi, Ureteral Calculi
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Oxycodone
Ketorolac
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Calculi
Eligibility Criteria
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
Sites / Locations
- Cleveland Clinic Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Oxycodone group
Ketorolac group
Arm Description
Patients randomized to 20 pills of 5 mg oxycodone by mouth every 6 hours as needed for pain after ureteroscopy.
Patients randomized to 20 pills of 10 mg ketorolac by mouth every 6 hours as needed for pain after ureteroscopy.
Outcomes
Primary Outcome Measures
Visual Analog Pain Score
Averaged pain score over five days post-operatively (measured 0 to 10 mm)
Secondary Outcome Measures
Ureteric Stent Symptom Questionnaire
A validated assessment tool for stent-related symptoms and their impact on patient quality of life
Medication Adverse Effects
Patient-reported medication related side effects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03888144
Brief Title
Study of Ketorolac Versus Opioid for Pain After Endoscopy
Acronym
SKOPE
Official Title
Study of Ketorolac Versus Opioid for Pain After Endoscopy (SKOPE): A Double-blinded Randomized Control Trial Comparing Outpatient Analgesic Efficacy of NSAIDs and Opioids in Patients Undergoing Ureteroscopy for Kidney Stones
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 13, 2017 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Calculi, Ureteral Calculi
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxycodone group
Arm Type
Active Comparator
Arm Description
Patients randomized to 20 pills of 5 mg oxycodone by mouth every 6 hours as needed for pain after ureteroscopy.
Arm Title
Ketorolac group
Arm Type
Experimental
Arm Description
Patients randomized to 20 pills of 10 mg ketorolac by mouth every 6 hours as needed for pain after ureteroscopy.
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
5 mg of oxycodone taken by mouth every 6 hours for 5 days
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Toradol
Intervention Description
10 mg of ketorolac taken by mouth every 6 hours for 5 days
Primary Outcome Measure Information:
Title
Visual Analog Pain Score
Description
Averaged pain score over five days post-operatively (measured 0 to 10 mm)
Time Frame
Daily for 5 days
Secondary Outcome Measure Information:
Title
Ureteric Stent Symptom Questionnaire
Description
A validated assessment tool for stent-related symptoms and their impact on patient quality of life
Time Frame
Post-operative days 1 and 5
Title
Medication Adverse Effects
Description
Patient-reported medication related side effects
Time Frame
Daily for 5 days
Other Pre-specified Outcome Measures:
Title
Pain Medication utilization
Description
Blinded study drug daily usage or alternative over the counter pain medication utilization. Additionally the proportion of patients in each group who utilized the provided "rescue" oxycodone pills.
Time Frame
Daily for 5 days
Title
Healthcare contact regarding refractory pain
Description
Occurrence of contacting healthcare professionals through a phone call, office visit, physician message or emergency room visit regarding refractory pain.
Time Frame
Up to Two months post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sriharan Sivalingam, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Ketorolac Versus Opioid for Pain After Endoscopy
We'll reach out to this number within 24 hrs