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

Randomized Trial of NSAID vs Placebo Prior to Ureteral Stent Removal

Sponsors

Lead sponsor: University of Colorado, Denver

Collaborator: Children's Hospital Colorado

Source University of Colorado, Denver
Brief 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.

Overall Status Recruiting
Start Date May 2014
Completion Date December 2020
Primary Completion Date December 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence of post-operative severe pain (pain score ≥ 7) 24 hours after stent removal
Secondary Outcome
Measure Time Frame
Incidence of "significantly worsening" pain 24 hours after stent removal
Change in pre- and post-operative pain score 24 hours after stent removal
Opioid usage post-operatively 24 hours after stent removal
Enrollment 40
Condition
Intervention

Intervention type: Drug

Intervention name: Ibuprofen

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

Arm group label: Liquid ibuprofen

Intervention type: Drug

Intervention name: Placebo

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

Arm group label: Liquid placebo

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

Gender: All

Minimum age: 4 Years

Maximum age: 17 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Jeffrey Campbell, MD Principal Investigator Children's Hospital Colorado
Overall Contact

Last name: Sheryl Holbrook

Email: [email protected]

Location
facility status investigator Children's Hospital Colorado Jeffrey Campbell, MD Principal 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 Sub-Investigator
Location Countries

United States

Verification Date

January 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Liquid ibuprofen

Arm group type: Experimental

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

Arm group label: Liquid placebo

Arm group type: Placebo Comparator

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

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov