Comparison of Infant Pain Responses Between Two Different Methods of Urine Collection for Diagnosis of Infection: Suprapubic Aspiration and Urinary Catheterization
试验速览
- 阶段
- 3 期
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- infant pain response, as measured by facial grimacing and changes in heart rate and oxygen saturation during the procedure
研究概览
简要总结
The purpose of this study is to determine which of the two procedures commonly used to collect urine, percutaneous suprapubic aspiration (SPA) and urethral catheterization (UC), is less painful, and the success rates and complication rates associated with both methods.
详细描述
Infants hospitalized in the NICU undergo numerous invasive and painful procedures. Exposure to early repeated painful procedures has been correlated with both short-term and long-term negative sequelae, such as altered pain responses and increased sensitivity to pain (Taddio 2005). Fifty eligible infants in the NICU will be randomized to undergo urine collection by either suprapubic aspiration (SPA) or urinary catheterization (UC). Outcome measures will include pain, procedure success, and procedure duration. Pain will be measured using facial grimacing (the infant's face will be videotaped for the entire procedure), heart rate and oxygen saturation. Procedure success will be defined by the collection of about 2mL of urine (Falcao, 1999). The procedure duration in seconds for the first attempt will be calculated. Infants will be monitored during the procedure for adverse events such as apnea, bradycardia, desaturation, emesis, increased ventilatory support. Results will be extremely valuable in aiding health care providers to choose a urine collection technique that minimizes the pain and maximizes the success of the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double
入排标准
- 年龄范围
- 1 Day 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants in the Neonatal Intensive Care Unit (NICU) who require urine samples for microbiological analysis
排除标准
- •Clinical diagnosis of birth asphyxia or seizures
- •Neurological conditions
- •Congenital anomalies associated with the central nervous system, gut, or genitourinary tract
- •Abdominal distension or abdominal infection/cellulitis
- •Colostomy
- •Inguinal hernia
- •Organomegaly
- •Bleeding diatheses (thrombocytopenia or coagulopathy)
- •Receiving analgesics or sedatives
结局指标
主要结局
infant pain response, as measured by facial grimacing and changes in heart rate and oxygen saturation during the procedure
次要结局
- success rate of obtaining a sample suitable for analysis
- adverse events, such as post-procedure haematuria, haemorrhage, haematoma, peritonitis, bowel perforation, abdominal wall abscess, and induction of infection, bladder perforation, urethral knots
- success rate of procedure according to infant factors; gestational age and sex