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

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

Sponsors

Lead sponsor: University of Texas Southwestern Medical Center

Source University of Texas Southwestern Medical Center
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.

Overall Status Completed
Start Date June 28, 2018
Completion Date August 30, 2019
Primary Completion Date June 30, 2019
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Unscheduled return to clinic or emergency room. Seven days following ureteral stent removal.
Visual Analog Pain (VAS) pain scale 24 hours following stent removal. Twenty-four hours following ureteral stent removal.
Injection Complication Within thirty days post injection.
Visual Analog Pain (VAS) pain scale 7 days following stent removal. Seven days following ureteral stent removal.
Secondary Outcome
Measure Time Frame
Opioid medication use following ureteral stent removal. Twenty-four hours following stent removal.
Missed work. Seven days following stent removal.
Enrollment 250
Condition
Intervention

Intervention type: Drug

Intervention name: Ketorolac

Description: IM injection of either normal saline or Ketorolac

Arm group label: Ketorolac

Intervention type: Drug

Intervention name: normal saline

Description: normal saline

Arm group label: control

Eligibility

Criteria:

Inclusion Criteria:

- patients 18 to 19 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, Coumadin, xarelto, eliquis, Plavix, or heparin

- Allergic reaction to NSAIDs

- Concurrent use of other NSAIDs within 24 hours

- Pregnancy (ketorolac contraindicated in this population)

- Recent myocardial infarction (MI)

Gender: All

Minimum age: 18 Years

Maximum age: 79 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Margaret Pearle, MD.PhD Principal Investigator UT Southwestern Medical Center
Location
facility UT Southwestern Medical Center
Location Countries

United States

Verification Date

May 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: control

Arm group type: Placebo Comparator

Description: normal saline 0.9%

Arm group label: Ketorolac

Arm group type: Active Comparator

Description: 30 mg of Ketorolac

Study Design Info

Allocation: Randomized

Intervention model: Single Group Assignment

Primary purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov