Skip to main content
OpenTrials
Completed

NCT Number: NCT02140970

Randomized Trial of NSAID vs Placebo Prior to Ureteral Stent Removal

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Disorder of Urinary Stent Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Multicystic renal dysplasia, bilateral Ureteral Spasm Ureteropelvic Junction Obstruction Urogenital Diseases Urolithiasis Urologic Diseases

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Incidence of Post-operative Severe Pain (Pain Score ≥ 7)

    Time frame: 24 hours after stent removal

    Two pain scales were used (Faces pain scale-revised [FPS-R] and visual analogue scale [VAS]) and converted to continuous value 0-10.

Secondary outcomes

  1. 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

  2. Change in Pre- and Post-operative Pain Score

    Time frame: 24 hours after stent removal

    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.

  3. Opioid Usage Post-operatively

    Time frame: 24 hours after stent removal

    This will be recorded in equivalents to milligrams intravenous morphine

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Children's Hospital Colorado

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
May 16, 2014
Registry last updated
Apr 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.