Randomized Trial of NSAID vs Placebo Prior to Ureteral Stent Removal

University of Colorado, Denver51 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Disorder of Urinary Stent Ureteral Spasm Ureteropelvic Junction Obstruction Urolithiasis

Interventions

IbuprofenDRUG

10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal

PlaceboDRUG

Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal

Eligibility

Sex: ALLMin age: 4 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 24 hours after stent removal

Secondary Outcomes

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

Time frame: 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.

Time frame: 24 hours after stent removal

Opioid Usage Post-operatively

This will be recorded in equivalents to milligrams intravenous morphine

Time frame: 24 hours after stent removal

Randomized Trial of NSAID vs Placebo Prior to Ureteral Stent Removal

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes