Mount Sinai West
New York, 10019, United States
NCT Number: NCT05924165
This is a randomized control trial comparing oral ketorolac and opioid medication for the use of post-operative analgesia.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
New York, 10019, United States
This is a randomized control trial comparing oral ketorolac (10mg, Q6 PRN) and oxycodone (5mg, Q6 PRN) medication for the use of post-operative analgesia after kidney stone removal surgery called percutaneous nephrolithotomy (PCNL). Primary endpoints are visual analog pain scores (VAS) for days 1-5 and day 10 post operatively. Secondary endpoints are pill counts, patient-related outcome survey (PROMIS) scores, emergency room visits, and patient telephone calls. 90 subjects will be enrolled, with 45 in each group.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oxycodone is an opioid that is used to relieve moderate to severe pain.
Ketorolac is an NSAID used to relieve moderately severe pain.
Time frame: post-op day 5 and post-op day 10
Visual Analog Scale (VAS) to measure pain: The minimum score of '0' indicates "no pain" and the maximum score of '10' indicates "Worst pain imaginable" along a line. Participants will be asked to mark the level of their pain along the line. Visual analog scale (VAS) pain scores will be recorded
Time frame: post-op at day 10
A pill count will be conducted of each prescribed postoperative medication.
Time frame: post-op up to day 10
Number of participants with pain related calls to the office recorded.
Time frame: post-op up to day 10
Number of participants with pain related visits to the office or Emergency Department (ED) visits recorded.
Time frame: post-op at day 10
Patients given a survey containing questions from Patient-related outcome survey (PROMIS) instruments.
A series of person-centered measures that evaluate and monitor physical, mental, and social health in adults and children. 10-item patient-reported questionnaire. standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.
Icahn School of Medicine at Mount Sinai
Other
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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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