Phase 2 N=125 Randomized Quadruple-blind Prevention

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

Pain · Urinary Stone · Urinary Calculi

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View on ClinicalTrials.gov: NCT04112160 ↗

Enrolled (actual)

125

Serious AEs

0.0%

Results posted

Jul 2020

Primary outcome: Primary: Number of Participants With Unscheduled Return to Clinic or Emergency Room — 8; 1 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Ketorolac (Drug); normal saline (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Texas Southwestern Medical Center
Primary completion: Jun 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Unscheduled Return to Clinic or Emergency Room	8; 1	—
PRIMARY Median Visual Analog Pain (VAS) Pain Scale Experienced by Participant 24 Hours Following Stent Removal	2; 1	—
PRIMARY Number of Participants That Experienced an Injection Complication	1; 1	—
PRIMARY Visual Analog Pain (VAS) Pain Scale 7 Days Following Stent Removal.	0; 0	—
SECONDARY Number of Patients That Required Opioid Medication Following Ureteral Stent Removal	17; 17	—
SECONDARY Average Number of Days the Participant Missed Work	2.3; 2.7	—

Summary

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

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04112160). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.