Clinical trial NCT04112160: Prospective Randomized Controlled Trial for Pain Relief After Office Ureteral Stent Removal
Official title: Prospective Randomized Controlled Trial for Pain Relief After Office Ureteral Stent Removal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Urinary Stone
Urinary Calculi
Keywords: stent removal, pain, kidney stones
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants With Unscheduled Return to Clinic or Emergency Room
timeFrame: Seven days following ureteral stent removal.
measure: Median Visual Analog Pain (VAS) Pain Scale Experienced by Participant 24 Hours Following Stent Removal
timeFrame: Twenty-four hours following ureteral stent removal.
measure: Number of Participants That Experienced an Injection Complication
timeFrame: Within thirty days post injection.
measure: Visual Analog Pain (VAS) Pain Scale 7 Days Following Stent Removal.
timeFrame: Seven days following ureteral stent removal.
Secondary outcomes:
measure: Number of Patients That Required Opioid Medication Following Ureteral Stent Removal
timeFrame: Twenty-four hours following stent removal.
measure: Average Number of Days the Participant Missed Work
timeFrame: Seven days following stent removal.
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Margaret Pearle, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johnson BA, Akhtar A, Crivelli J, Steinberg RL, Sasaki J, Street A, Antonelli JA, Pearle MS. Impact of an Enhanced Recovery After Surgery Protocol on Unplanned Patient Encounters in the Early Postoperative Period After Ureteroscopy. J Endourol. 2022 Mar;36(3):298-302. doi: 10.1089/end.2021.0435. Epub 2021 Oct 14.