Randomized Trial of NSAID vs Placebo Prior to Ureteral Stent Removal

Not Applicable

Completed

• Conditions: Urolithiasis; Ureteropelvic Junction Obstruction; Disorder of Urinary Stent; Ureteral Spasm
• Interventions: Drug: Placebo; Drug: Ibuprofen

• Registration Number: NCT02140970
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-14
• Study First Submitted QC: 2014-05-14
• Study First Posted: 2014-05-16
• Primary Completion: 2020-01-11
• Study Completion: 2020-01-11
• Status Verified: 2021-03
• Results First Submitted: 2021-03-29
• Results First Submitted QC: 2021-03-29
• Last Update Submitted: 2021-03-29
• Results First Posted: 2021-04-26
• Last Update Posted: 2021-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liquid placebo	Placebo	Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal
Liquid ibuprofen	Ibuprofen	10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of "Significantly Worsening" Pain	24 hours after stent removal	Incidence of "significantly worsening" pain is defined as any increase ≥ 2 between the pre-operative and post-operative pain scale assessments
Change in Pre- and Post-operative Pain Score	24 hours after stent removal	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.
Opioid Usage Post-operatively	24 hours after stent removal	This will be recorded in equivalents to milligrams intravenous morphine

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States