At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 81 enrolled
Drug / intervention
Oxycodone +1 moredrug
Likely dose
Ketorolac 10 mg orally every 6 hours for 5 days OR Oxycodone 5 mg orally every 6 hours for 5 daysAI-extracted
Key inclusion· 4
- ✓Confirmed kidney or ureteral stones on CT abdomen/pelvis undergoing unilateral ureteroscopy at study site
- ✓Post-operative unilateral ureteral stent placement required
- ✓Capable of informed consent and study compliance
- ✓Capable and willing to fulfill study requirements
Key exclusion· 9
- ✕Active or prior peptic ulcer disease, GI bleeding, or perforation
- ✕History of coronary artery bypass graft surgery
- ✕Bleeding disorder
- ✕GFR <60 mL/min/1.73m² by MDRD equation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Oxycodone and Ketorolac for Kidney Calculi and Ureteral Calculi. Completed, enrolled 81 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Calculi, Ureteral Calculi
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
201820192020202120222023202420252026
Enrollment StartOct 2017
First PostedMar 2019
Primary CompletionAug 2021
TodayJul 2026
First PostedMar 25, 2019
Enrollment StartOct 13, 2017
Primary CompletionAug 1, 2021
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 7.3 years ago
Interventions
Oxycodonedrug
5 mg of oxycodone taken by mouth every 6 hours for 5 days
Ketorolacdrug
10 mg of ketorolac taken by mouth every 6 hours for 5 days