Randomized Clinical Trial of Lidocaine Analgesia for Urethral Catheterization in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain Score on the Face, Legs, Arms, Cry, Consolability (FLACC) Scale
研究概览
简要总结
Primary Aim
- To measure difference in pain via Faces, Legs, Activity, Cry and Consolability (FLACC) Pain Scale score at the time of transurethral bladder catheterization for urine collection in children who do and do not receive intraurethral 2% lidocaine jelly prior to catheterization.
Secondary Aims
- To assess gender differences in pain control during transurethral bladder catheterization with and without pain control using intraurethral 2% lidocaine jelly.
- To assess patient discomfort with administration of intraurethral 2% lidocaine jelly.
To assess parental impression of discomfort between intervention and control groups. 3. To assess pain associated with the administration of intraurethral 2% lidocaine jelly. 4. To measure difference in pain via Modified Behavioral Pain Scale (MBPS) score at the time of TUBC for urine collection in children who do and do not receive intraurethral 2% lidocaine jelly prior to catheterization.
详细描述
Purpose: To determine whether use of transurethral lidocaine prior to transurethral catheterization for sterile urine collection decreases procedural pain in children 0-3 years old. Primary Aim
- To measure difference in pain via Faces, Legs, Activity, Cry and Consolability (FLACC) Pain Scale score at the time of transurethral bladder catheterization for urine collection in children who do and do not receive intraurethral 2% lidocaine jelly prior to catheterization.
Secondary Aims
- To assess gender differences in pain control during transurethral bladder catheterization with and without pain control using intraurethral 2% lidocaine jelly.
- To assess patient discomfort with administration of intraurethral 2% lidocaine jelly.
To assess parental impression of discomfort between intervention and control groups. 3. To assess pain associated with the administration of intraurethral 2% lidocaine jelly. 4. To measure difference in pain via Modified Behavioral Pain Scale (MBPS) score at the time of TUBC for urine collection in children who do and do not receive intraurethral 2% lidocaine jelly prior to catheterization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 0-3 years
- •English or Spanish speaking
- •Legal guardian present to provide consent
- •Medical indication for TUBC during the patient's ED visit
排除标准
- •Severe developmental delay or impaired mentation
- •Neural tube defect, paraplegia, or other condition altering urethral sensation
- •Known urethral stricture, anatomic abnormality or reconstruction
- •History of sexual abuse
- •Patient weight less than 2.3 kg
- •Allergy or previous adverse reaction to lidocaine
- •Previous enrollment in the study
- •Prior successful or attempted TUBC in previous 7 days
研究组 & 干预措施
Lidocaine
The Intervention is the application of intraurethral lidocaine 5 minutes prior to urethral catheterization.
干预措施: Lidocaine (Drug)
结局指标
主要结局
Pain Score on the Face, Legs, Arms, Cry, Consolability (FLACC) Scale
时间窗: At time of procedure (up to 30 seconds after catheter insertion)
Pain of urethral catheterization will be determined in the lidocaine and no lidocaine groups. Score range for the FLACC scale was between 0-10 where higher score is more pain.
次要结局
未报告次要终点
研究者
Eileen Klein
Investigator
Seattle Children's Hospital