Prospective Randomized Controlled Trial for Pain Relief After Office Ureteral Stent Removal

Study Overview
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Brief Summary
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This is a prospective randomized double-blind controlled trial assessing the benefits of intramuscular ketorolac before or immediately after office ureteral stent removal.

Detailed Description
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Patients who are undergoing cystoscopy with ureteral stent removal at the University of Texas Southwestern Medical Center and have no contraindications to receiving ketorolac will be eligible. Patients will be randomized to receive either a 1 mL injection of ketorolac tromethamine or 1 mL injection of normal saline (0.9%) as the control arm. Ketorolac is a member of the pyrrolo-pyrrole group of non steroid anti inflammatory drugs. The mechanism of action of ketorolac, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition. The peak analgesic effect occurs within 2-3 hours. If no contraindications exist, ketorolac can be safely given to patients of any age in the 30 mg intramuscular formulation if given as a one time dose according to the package insert. Normal saline contains 0.9% of Sodium chloride in each mL. Like ketorolac, it is a clear solution and given that there are no major side effects of normal saline it is a good control for our study. It is packaged in a single dose vial that contains 100 mL. It is preservative free and stored at room temperature (20-25°C). Local pain at the injection site may occur, temporarily. The investigators will specifically look at pain scores before and after stent removal as well as narcotic medication use, telephone calls and/or emergency room visits for pain. Based on the rate of renal colic from our quality improvement project and prior work, the investigators calculated the maximum number of local subjects to be consented for this study to be n=116 (see biostatistics section). The study is expected to last 6 months.

Official Title
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Prospective Randomized Controlled Trial for Pain Relief After Office Ureteral Stent Removal

Conditions
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Pain, Urinary Stone, Urinary Calculi

Intervention / Treatment
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* Drug: Ketorolac
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients 18 to 79 who have undergone a cystoscopy with indwelling double-J ureteral stent placement at Clements University Hospital and are presenting to the office for cystoscopy and stent removal. Exclusion Criteria: eGFR <50 any active or history of peptic ulcer disease or GI bleeding Bleeding disorder, suspected of confirmed cerebrovascular bleeding, hemorrhagic diathesis, or incomplete hemostasis Concurrent use of Aspirin 325mg, wafarin, rivaroxaban, apixaban, clopidogrel, or heparin Allergic reaction to NSAIDs Concurrent use of other NSAIDs within 24 hours Pregnancy (ketorolac contraindicated in this population) Recent myocardial infarction (MI)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control<br>normal saline 0.9% | Drug: normal saline<br>* normal saline<br>* Other names: Placebo;|
| Active Comparator: Ketorolac<br>30 mg of Ketorolac | Drug: Ketorolac<br>* IM injection of either normal saline or Ketorolac<br>* Other names: Toradol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Unscheduled Return to Clinic or Emergency Room | Any unscheduled in-person clinical encounter secondary to renal colic following ureteral stent removal. | Seven days following ureteral stent removal. | 
| Median Visual Analog Pain (VAS) Pain Scale Experienced by Participant 24 Hours Following Stent Removal | Perceived pain on a scale of 0-10 (0= no pain, 10= worst pain ever experienced) recorded by phone call 24 hours after stent removal. | Twenty-four hours following ureteral stent removal. | 
| Number of Participants That Experienced an Injection Complication | Determine if there is any infection site pain or reaction. Determine any complications related to administration of the medication. | Within thirty days post injection. | 
| Visual Analog Pain (VAS) Pain Scale 7 Days Following Stent Removal. | Perceived pain on a scale of 0-10 (0= no pain, 10= worst pain ever experienced) recorded by phone call 7 days after stent removal. | Seven days following ureteral stent removal. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients That Required Opioid Medication Following Ureteral Stent Removal | Determine the use of opioid medications in morphine equivalents in the 24 hours following stent removal. | Twenty-four hours following stent removal. | 
| Average Number of Days the Participant Missed Work | Determine amount of missed work or school due to renal colic following ureteral stent removal. | Seven days following stent removal. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stent removal, pain, kidney stones