Randomized Trial of NSAID vs Placebo Prior to Ureteral Stent Removal

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Disorder of Urinary Stent; Ureteral Spasm; Urolithiasis; Ureteropelvic Junction Obstruction

Treatments: Drug: Ibuprofen; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02140970

14-0514

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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51 participants in 2 patient groups, including a placebo group

Liquid ibuprofen

Experimental group

Description:

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

Treatment:

Drug: Ibuprofen

Liquid placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo