Phase 2
Completed N=125
Prospective Randomized Controlled Trial for Pain Relief After Office Ureteral Stent Removal
Postoperative Pain · Urinary Stone · Urinary Calculi
Source: ClinicalTrials.gov NCT04112160 ↗
Enrolled (actual)
125
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcomePrimary: Number of Participants With Unscheduled Return to Clinic or Emergency Room — 8; 1 Participants
Summary
This is a prospective randomized double-blind controlled trial assessing the benefits of intramuscular ketorolac before or immediately after office ureteral stent removal.
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 | — |
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)
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. Informational only — not medical advice.