Randomized Trial of NSAID vs Placebo Prior to Ureteral Stent Removal

Urolithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02140970
• Other study ID #: 14-0514
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: January 11, 2020

Study information

• Verified date: March 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 11, 2020
• Est. primary completion date: January 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Disorder of Urinary Stent
• Hydronephrosis
• Multicystic Dysplastic Kidney
• Ureteral Obstruction
• Ureteral Spasm
• Ureteropelvic Junction Obstruction
• Urinary Calculi
• Urolithiasis

Intervention

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

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Children's Hospital Colorado

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Post-operative Severe Pain (Pain Score = 7)	Two pain scales were used (Faces pain scale-revised [FPS-R] and visual analogue scale [VAS]) and converted to continuous value 0-10.	24 hours after stent removal
Secondary	Incidence of "Significantly Worsening" Pain	Incidence of "significantly worsening" pain is defined as any increase = 2 between the pre-operative and post-operative pain scale assessments	24 hours after stent removal
Secondary	Change in Pre- and Post-operative Pain Score	Pain will be assessed via a 10 point [NAME OF SCALE] scale. Possible scores range from 0 to 10, with higher scores indicating more severe pain and a worse outcome.	24 hours after stent removal
Secondary	Opioid Usage Post-operatively	This will be recorded in equivalents to milligrams intravenous morphine	24 hours after stent removal