Study of Ketorolac Versus Opioid for Pain After Endoscopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Kidney Calculi, Ureteral Calculi

Intervention / Treatment
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* Drug: Oxycodone
* Drug: Ketorolac


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with kidney or ureteral stones confirmed on imaging (CT of the abdomen pelvis) and who elect for definitive treatment via unilateral ureteroscopy at one of two hospital sites within a tertiary care institution Patients who post-operatively receive a unilateral ureteral stent Capable of giving informed consent Capable and willing to fulfill requirements of the study Exclusion Criteria: Active or history of peptic ulcer disease, gastrointestinal bleeding or perforation History of coronary artery bypass graft surgery History of a bleeding disorder GFR less than 60 mL/min/1.73m2 (MDRD equation) Chronic use of opioid or other pain medication including NSAIDs (greater than 12 weeks) Known allergy to either ketorolac or oxycodone Known or suspected pregnancy Solitary kidney Patients taking anticoagulant medication or antiplatelet medication (e.g. warfarin, clopidogrel, pradaxa, rivaroxaban, apixaban etc). Inability to give informed consent or unable to meet requirements of the study for any reason

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxycodone group<br>Patients randomized to 20 pills of 5 mg oxycodone by mouth every 6 hours as needed for pain after ureteroscopy. | Drug: Oxycodone<br>* 5 mg of oxycodone taken by mouth every 6 hours for 5 days<br>|
| Experimental: Ketorolac group<br>Patients randomized to 20 pills of 10 mg ketorolac by mouth every 6 hours as needed for pain after ureteroscopy. | Drug: Ketorolac<br>* 10 mg of ketorolac taken by mouth every 6 hours for 5 days<br>* Other names: Toradol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Pain Score | Averaged pain score over five days post-operatively (measured 0 to 10 mm) | Daily for 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ureteric Stent Symptom Questionnaire | A validated assessment tool for stent-related symptoms and their impact on patient quality of life | Post-operative days 1 and 5 | 
| Medication Adverse Effects | Patient-reported medication related side effects | Daily for 5 days |