N/A
N=49
Randomized Trial of NSAID vs Placebo Prior to Ureteral Stent Removal
Disorder of Urinary Stent · Ureteral Spasm · Ureteropelvic Junction Obstruction · Urolithiasis
Bottom Line
View on ClinicalTrials.gov: NCT02140970 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Incidence of Post-operative Severe Pain (Pain Score ≥ 7) — 2; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ibuprofen (Drug); Placebo (Drug)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Post-operative Severe Pain (Pain Score ≥ 7) |
2; 1 | — |
| SECONDARY Incidence of "Significantly Worsening" Pain |
3; 5 | — |
| SECONDARY Change in Pre- and Post-operative Pain Score |
0.4; 0.2 | — |
| SECONDARY Opioid Usage Post-operatively |
0.0; 0.0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02140970). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.