Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
NCT Number: NCT03888144
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.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 4
Cleveland, Ohio, 44195, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
5 mg of oxycodone taken by mouth every 6 hours for 5 days
10 mg of ketorolac taken by mouth every 6 hours for 5 days
Other names: Toradol
Time frame: 5 days
Patient Reported Visual Analogue Score scored from 0-10 with lower scores equaling less pain.
Time frame: Post-operative days 1 to 5
the use of opioid medication as per the study protocol; Required study pills
Time frame: post operative day 1-5
the use of rescue opioid medication as per the study protocol; use of rescue medication by the patients
Time frame: 5 days
number of days patient spent confined to bed post operatively
Time frame: 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)
The Cleveland Clinic
Other
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
Acronym: SKOPE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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