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

January 8, 2024 updated by: Margaret Pearle, University of Texas Southwestern Medical Center
This is a prospective randomized double-blind controlled trial assessing the benefits of intramuscular ketorolac before or immediately after office ureteral stent removal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control
normal saline 0.9%
Drug: normal saline
normal saline
Other Names:
  • Placebo
Active Comparator: Ketorolac
30 mg of Ketorolac
Drug: Ketorolac
IM injection of either normal saline or Ketorolac
Other Names:
  • Toradol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Unscheduled Return to Clinic or Emergency Room
Time Frame: Seven days following ureteral stent removal.
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
Time Frame: Twenty-four hours following ureteral 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
Time Frame: Within thirty days post injection.
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.
Time Frame: Seven days following ureteral 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
Time Frame: Twenty-four hours following 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
Time Frame: Seven days following stent removal.
Determine amount of missed work or school due to renal colic following ureteral stent removal.
Seven days following stent removal.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Margaret Pearle, MD.PhD, UT Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2018

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

August 30, 2019

Study Registration Dates

First Submitted

September 25, 2019

First Submitted That Met QC Criteria

October 1, 2019

First Posted (Actual)

October 2, 2019

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU 012018-080

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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