Randomized Trial of NSAID vs Placebo Prior to Ureteral Stent Removal

Study Overview
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Brief Summary
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This study plans to learn more about whether ibuprofen can reduce pain after removal of a ureteral stent more than a placebo. Some patients experience pain after removal of a ureteral stent. The investigators plan to learn how often this occurs and whether it can be prevented. The investigators hypothesize that children who have a temporary, indwelling ureteral stent will experience a significantly less post-operative pain if given a non-steroidal anti-inflammatory (NSAID) prior to removal of the ureteral stent when compared to placebo. The investigators hypothesize that the incidence of severe post-stent removal pain is similar to an adult population.

Official Title
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Double-blind, Placebo-controlled Randomized Controlled Trial of NSAID Prior to Ureteral Stent Removal in a Pediatric Population

Conditions
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Ureteropelvic Junction Obstruction, Urolithiasis, Disorder of Urinary Stent, Ureteral Spasm

Intervention / Treatment
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* Drug: Ibuprofen
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ages 4-17 unilateral ureteral stent placed after ureteropelvic junction obstruction repair or treatment of upper tract urolithiasis Exclusion Criteria: bilateral stents undergoing other concomitant procedure at time of planned ureteral stent removal indication for stent other than ureteropelvic junction obstruction repair or treatment of upper tract urolithiasis pregnant developmental delay allergy to ibuprofen or non-steroidal anti-inflammatory medication class chronic kidney disease prior renal transplant history of nasal polyps history of asthma

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liquid ibuprofen<br>10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal | Drug: Ibuprofen<br>* 10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal<br>|
| Placebo Comparator: Liquid placebo<br>Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal | Drug: Placebo<br>* Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Post-operative Severe Pain (Pain Score ≥ 7) | Two pain scales were used (Faces pain scale-revised [FPS-R] and visual analogue scale [VAS]) and converted to continuous value 0-10. | 24 hours after stent removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Significantly Worsening Pain | Incidence of significantly worsening pain is defined as any increase ≥ 2 between the pre-operative and post-operative pain scale assessments | 24 hours after stent removal | 
| Change in Pre- and Post-operative Pain Score | Pain will be assessed via a 10 point [NAME OF SCALE] scale. Possible scores range from 0 to 10, with higher scores indicating more severe pain and a worse outcome. | 24 hours after stent removal | 
| Opioid Usage Post-operatively | This will be recorded in equivalents to milligrams intravenous morphine | 24 hours after stent removal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ureteral stent, stent pain, ureteral spasm, NSAID, ibuprofen, placebo, ureteropelvic junction obstruction, urolithiasis