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Randomized Trial of NSAID vs Placebo Prior to Ureteral Stent Removal

NCT02140970 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2021-04-26

Study results available
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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.

Conditions

  • Ureteropelvic Junction Obstruction
  • Urolithiasis
  • Disorder of Urinary Stent
  • Ureteral Spasm

Interventions

DRUG

Ibuprofen

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

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

Sponsors & Collaborators

  • Children's Hospital Colorado

    collaborator OTHER

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Jeffrey Campbell, MD · Children's Hospital Colorado

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2020-01-11
Completion
2020-01-11

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02140970 on ClinicalTrials.gov