NCT03888144

Study of Ketorolac Versus Opioid for Pain After Endoscopy

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Kidney Calculi
• Ureteral Calculi

Interventions

Type	Name	Description
DRUG	Oxycodone	5 mg of oxycodone taken by mouth every 6 hours for 5 days
DRUG	Ketorolac	10 mg of ketorolac taken by mouth every 6 hours for 5 days

Timeline

• Start date: 2017-10-13
• Primary completion: 2021-08-01
• Completion: 2021-08-01
• First posted: 2019-03-25
• Last updated: 2025-12-23
• Results posted: 2025-12-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study