Clinical trial NCT03888144: Study of Ketorolac Versus Opioid for Pain After Endoscopy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Calculi
Ureteral Calculi
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Pain Score
timeFrame: Daily for 5 days
Secondary outcomes:
measure: Ureteric Stent Symptom Questionnaire
timeFrame: Post-operative days 1 and 5
measure: Medication Adverse Effects
timeFrame: Daily for 5 days
Other outcomes:
measure: Pain Medication utilization
timeFrame: Daily for 5 days
measure: Healthcare contact regarding refractory pain
timeFrame: Up to Two months post-op
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Sriharan Sivalingam, MD
role: PRINCIPAL_INVESTIGATOR
References: