NCT02140970

Randomized Trial of NSAID vs Placebo Prior to Ureteral Stent Removal

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Disorder of Urinary Stent
• Ureteral Spasm
• Ureteropelvic Junction Obstruction
• Urolithiasis

Interventions

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

Timeline

• Start date: 2014-05-01
• Primary completion: 2020-01-11
• Completion: 2020-01-11
• First posted: 2014-05-16
• Last updated: 2021-04-26
• Results posted: 2021-04-26

Locations

1 site across 1 country: United States