Randomized Trial of NSAID vs Placebo Prior to Ureteral Stent Removal
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ClinicalTrials.gov Identifier: NCT02140970 |
Recruitment Status :
Recruiting
First Posted : May 16, 2014
Last Update Posted : February 18, 2021
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Disorder of Urinary Stent Ureteral Spasm Ureteropelvic Junction Obstruction Urolithiasis | Drug: Ibuprofen Drug: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Double-blind, Placebo-controlled Randomized Controlled Trial of NSAID Prior to Ureteral Stent Removal in a Pediatric Population |
Study Start Date : | May 2014 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | December 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Liquid ibuprofen
10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal
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Drug: Ibuprofen
10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal |
Placebo Comparator: 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
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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 |
- Incidence of post-operative severe pain (pain score ≥ 7) [ Time Frame: 24 hours after stent removal ]
- Incidence of "significantly worsening" pain [ Time Frame: 24 hours after stent removal ]Incidence of "significantly worsening" pain is defined as any increase ≥ 2 between the pre-operative and post-operative pain scale assessments
- Change in pre- and post-operative pain score [ Time Frame: 24 hours after stent removal ]
- Opioid usage post-operatively [ Time Frame: 24 hours after stent removal ]This will be recorded in equivalents to milligrams intravenous morphine

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Ages Eligible for Study: | 4 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02140970
Contact: Sheryl Holbrook | sheryl.holbrook@ucdenver.edu | ||
Contact: Jeffrey Campbell, MD | jeffrey.campbell@childrenscolorado.org |
United States, Colorado | |
Children's Hospital Colorado | Recruiting |
Aurora, Colorado, United States, 80045 | |
Principal Investigator: Jeffrey Campbell, MD | |
Sub-Investigator: Duncan Wilcox, MD, MBBS | |
Sub-Investigator: Vijay Vemulakonda, MD, JD | |
Sub-Investigator: Nicholas Cost, MD | |
Sub-Investigator: Kyle Rove, MD | |
Sub-Investigator: David Chalmers, MD | |
Sub-Investigator: Alan Bielsky, MD |
Principal Investigator: | Jeffrey Campbell, MD | Children's Hospital Colorado |
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov Identifier: | NCT02140970 |
Other Study ID Numbers: |
14-0514 |
First Posted: | May 16, 2014 Key Record Dates |
Last Update Posted: | February 18, 2021 |
Last Verified: | February 2021 |
ureteral stent stent pain ureteral spasm NSAID |
ibuprofen placebo ureteropelvic junction obstruction urolithiasis |
Urolithiasis Hydronephrosis Ureteral Obstruction Multicystic Dysplastic Kidney Urologic Diseases Kidney Diseases Ureteral Diseases Urogenital Abnormalities Kidney Diseases, Cystic Congenital Abnormalities Ibuprofen |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |