CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 51 enrolled
Drug / intervention
Ibuprofen +1 moredrug
Likely dose
Ibuprofen 10 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02140970
NCT02140970N/ACompleted

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

University of Colorado, Denver·interventional·Posted May 16, 2014·Updated Apr 26, 2021

In Brief

A clinical study evaluating Ibuprofen and Placebo for Disorder of Urinary Stent and 3 related conditions. Completed, enrolled 51 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 16, 2014
Enrollment StartMay 1, 2014
Primary CompletionJan 11, 2020
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 12.1 years ago

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