An Early Phase 1 interventional study of Oxycodone and Ketorolac in Urologic Diseases, sponsored by University Hospitals Cleveland Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-11.
Sponsored by University Hospitals Cleveland Medical Center · Early Phase 1, Interventional, and Treatment
Goal of this study is to evaluate how pain is controlled after outpatient urologic surgeries. Patients will receive either opioid pain medication or non-opioid medication for pain control. A survey will be conducted at the post-operative appointment to evaluate for pain control.
Patients will be approached in the pre-operative area prior to their outpatient urologic surgery. Informed Consent will be obtained at that time. Patients will be instructed that they will receive a prescription for either opioid pain medication or non-opioid medication for after surgery. The opioid medication includes oxycodone, while the non-opioid includes ketoralac, a non-steroidal anti-inflammatory medication. Subjects will be assigned randomly to either medication. Standard of care after outpatient urologic surgery is either oxycodone or ketoralac, however there is no previous research on whether one is superior than the other. These drugs were chosen because they are the most commonly used medications after outpatient urologic surgery. The study team and patients will not be blinded to the treatment.
They will also receive instructions for non-opioid pain management. If the patients require additional pain medication after surgery, they are instructed to call the provider's office for further evaluation and treatment. The patient's physician will prescribe further medication if warranted. The post-operative appointment is scheduled 2-3 weeks after surgery. At the post-operative appointment, patients will then be given a four question paper survey inquiring how well their pain was managed, how many pills were taken, if any additional non-opioid medications were taken for pain, and how the extra pills were disposed. Other PHI that will be collected includes patient's age, gender, past medical history, past surgical history, renal function, prior medications, and current surgery.
197 studies on the registry are indexed under Urologic Diseases; 49 are open to participants now.
This study's enrollment of 150 is above the median of 80 across 138 interventional studies indexed under Urologic Diseases.
Browse Urologic Diseases studies →University Hospitals Cleveland Medical Center is the lead sponsor of 293 studies on the registry; 43 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 30 (86%) have results posted.
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Exclusion Criteria:
Patients receive opioid medication, oxycodone, after outpatient urologic surgery.
Drug: Oxycodone
Patients receive a non-opioid medication, ketorolac, after outpatient urologic surgery.
Drug: Ketorolac
Pain control
Survey evaluating how well pain was controlled
Time frame: within 6 weeks of surgery
Number of pills used
Survey evaluating number of pills used
Time frame: within 6 weeks of surgery
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Oxycodone · Ketorolac
University Hospitals Cleveland Medical Center →