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

NCT04112160 | Completed Phase 2 Results FDA Drug

• 1 other identifier: STU 012018-080
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Urinary Stone; Urinary Calculi

Keywords

stent removal, pain, kidney stones

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Number of Patients That Required Opioid Medication Following Ureteral Stent Removal

  Twenty-four hours following stent removal.

• Average Number of Days the Participant Missed Work

  Seven days following stent removal.

Study Arms (2)

control

PLACEBO COMPARATOR

normal saline 0.9%

Drug: normal saline

Ketorolac

ACTIVE COMPARATOR

30 mg of Ketorolac

Drug: Ketorolac

Interventions

Ketorolac DRUG

IM injection of either normal saline or Ketorolac

Also known as: Toradol

Ketorolac

normal saline DRUG

normal saline

Also known as: Placebo

control

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• 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.

  PMID: 34569278 DERIVED

MeSH Terms

Conditions

Pain; Urinary Calculi; Kidney Calculi

Interventions

Ketorolac; Ketorolac Tromethamine; Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Nephrolithiasis; Kidney Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

There are inherent variations in the size/location of nephrolithiasis, surgical/stent parameters, and patient characteristics that cannot be be defined or controlled.

Results Point of Contact

• Title: Dr. Brett Johnson
• Organization: UT Southwestern Dept of Urology

brett.johnson@utsouthwestern.edu

214-645-3526

Study Officials

• Margaret Pearle, MD.PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: October 2, 2019
• Study Start: June 28, 2018
• Primary Completion: June 30, 2019
• Study Completion: August 30, 2019
• Last Updated: January 10, 2024
• Results First Posted: July 22, 2020

Record last verified: 2024-01

Locations

US (1)