Clinical Trial: Randomized Trial of NSAID vs Placebo Prior to Ureteral Stent Removal
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Double-blind, Placebo-controlled Randomized Controlled Trial of NSAID Prior to Ureteral Stent Removal in a Pediatric Population
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.
Detailed Summary:
Sponsor: University of Colorado, Denver
Current Primary Outcome: Incidence of post-operative severe pain (pain score ≥ 7) [ Time Frame: 24 hours after stent removal ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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
Original Secondary Outcome: Same as current
Information By: University of Colorado, Denver
Dates:
Date Received: May 14, 2014
Date Started: May 2014
Date Completion: October 2017
Last Updated: April 12, 2017
Last Verified: April 2017
