Double-blind, Placebo-controlled Randomized Controlled Trial of NSAID Prior to Ureteral Stent Removal in a Pediatric Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Incidence of Post-operative Severe Pain (Pain Score ≥ 7)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ages 4-17
- •unilateral ureteral stent placed after ureteropelvic junction obstruction repair or treatment of upper tract urolithiasis
排除标准
- •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
- •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
研究组 & 干预措施
Liquid ibuprofen
10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal
干预措施: Ibuprofen (Drug)
Liquid placebo
Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Post-operative Severe Pain (Pain Score ≥ 7)
时间窗: 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.
次要结局
- 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)