Study of Ketorolac Versus Opioid for Pain After Endoscopy

Kidney Calculi Clinical Trial

— SKOPE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03888144
• Other study ID #: 17-872
• Status: Completed
• Phase: Phase 4
• Start date: October 13, 2017
• Est. completion date: August 1, 2021

Study information

• Verified date: August 2021
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis
• Ureteral Calculi
• Ureterolithiasis

Intervention

Drug:
• Oxycodone
5 mg of oxycodone taken by mouth every 6 hours for 5 days
• Ketorolac
10 mg of ketorolac taken by mouth every 6 hours for 5 days

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain Medication utilization	Blinded study drug daily usage or alternative over the counter pain medication utilization. Additionally the proportion of patients in each group who utilized the provided "rescue" oxycodone pills.	Daily for 5 days
Other	Healthcare contact regarding refractory pain	Occurrence of contacting healthcare professionals through a phone call, office visit, physician message or emergency room visit regarding refractory pain.	Up to Two months post-op
Primary	Visual Analog Pain Score	Averaged pain score over five days post-operatively (measured 0 to 10 mm)	Daily for 5 days
Secondary	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
Secondary	Medication Adverse Effects	Patient-reported medication related side effects	Daily for 5 days