Randomized Trial of NSAID vs Placebo Prior to Ureteral Stent Removal
NCT ID: NCT02140970
Last Updated: 2021-04-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2014-05-31
2020-01-11
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Liquid ibuprofen
10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal
Ibuprofen
10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal
Liquid placebo
Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal
Placebo
Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal
Interventions
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Ibuprofen
10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal
Placebo
Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal
Eligibility Criteria
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Inclusion Criteria
* unilateral ureteral stent placed after ureteropelvic junction obstruction repair or treatment of upper tract urolithiasis
Exclusion Criteria
* 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
4 Years
17 Years
ALL
No
Sponsors
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Children's Hospital Colorado
OTHER
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Jeffrey Campbell, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Colorado
Locations
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Children's Hospital Colorado
Aurora, Colorado, United States
Countries
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References
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Tadros NN, Bland L, Legg E, Olyaei A, Conlin MJ. A single dose of a non-steroidal anti-inflammatory drug (NSAID) prevents severe pain after ureteric stent removal: a prospective, randomised, double-blind, placebo-controlled trial. BJU Int. 2013 Jan;111(1):101-5. doi: 10.1111/j.1464-410X.2012.11214.x. Epub 2012 May 11.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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14-0514
Identifier Type: -
Identifier Source: org_study_id
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