Intranasal Fentanyl Versus Placebo for Catheterization During a Voiding Cystourethrogram in Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change in pain before and after catheterization for the VCUG.
研究概览
简要总结
The purpose of this study is to determine whether intranasal fentanyl is better than placebo at decreasing pain in children 4-8 years of age during urinary catheterization for a VCUG study.
详细描述
Studies have shown that the voiding cystourethrogram (VCUG) can be distressful and painful for children as the child is catheterized during the procedure. Currently no sedation or analgesia is recommended for the procedure. The practice of pediatrics is constantly seeking measures to decrease pain and distress for children. The opioid fentanyl was originally synthesized in the 1950's and 60's as an alternative to morphine and meperidine. The safety and efficacy of intranasal (IN) fentanyl has been previously demonstrated in the setting of a pediatric emergency department.
We are proposing the use of IN fentanyl for analgesia prior to the catheterization for a voiding cystourethrogram (VCUG). If we prove that IN fentanyl is effective in reducing the pain while ensuring patient safety, it could become the analgesic of choice for this procedure.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 4-8 years
- •Scheduled VCUG at Sick Kids
- •Understand the consent and assent form in English
排除标准
- •Previous adverse events to fentanyl or any opioid
- •History of a chronic respiratory or cardiac illness
- •Children with developmental delay
- •Children with bilateral nasal congestion.
研究组 & 干预措施
1
干预措施: Fentanyl (Drug)
2
干预措施: Sterile water (Drug)
结局指标
主要结局
Change in pain before and after catheterization for the VCUG.
时间窗: Will be measured up until 30 mins after the VCUG procedure.
次要结局
- Heart rate, respiratory rate and oxygen saturation just prior to and after the administration of fentanyl.(Every 5 minutes until 30 minutes after the VCUG procedure.)
- Nausea, vomiting, itching, nasal pain/irritation or any other side effects.(Will be measured up until 30 mins after the VCUG procedure.)
- Length of stay in diagnostic suite(Time frame determined by outcome)