Analgesia During Pediatric Digestive Endoscopy: a Comparison of Two Protocols for Procedural Sedation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- pain score
研究概览
简要总结
The purpose of this study is to determine whether ketamine, midazolam, and meperidine are more effective than midazolam and meperidine alone for procedural sedation and analgesia in pediatric digestive endoscopy. Secondary outcomes are the incidence of cardiorespiratory side effects and the necessity of rescue doses.
详细描述
90 patients will be included. The sedation will include 0.1mg/kg, max 5mg iv of midazolam, 1mg/kg, max 50mg iv of meperidine, and placebo (0.9%NaCl) or ketamine 0.5mg/kg iv. Rescue doses will be given as usual, using meperidine and or midazolam 50% of the initial dose.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children =/> 10 years of age
- •Undergoing elective diagnostic colonoscopy
- •ASA score class 1-3.
排除标准
- •Children younger than 10 years of age
- •Known epilepsy under treatment
- •ASA score class 4 or more
- •Interventional colonoscopy (e.g.polypectomy)
研究组 & 干预措施
ketamine
group with triple sedation (ketamine, midazolam, meperidine)
干预措施: ketamine (Drug)
placebo
group with conventional sedation and placebo ( midazolam, meperidine and placebo)
干预措施: ketamine (Drug)
结局指标
主要结局
pain score
时间窗: after one year
pain scores are accorded at the end of each endoscopy. Pain scores of the two groups will be compared after one year
次要结局
- necessity of cardiopulmonary intervention (Oxygen requirements)(after one year)
研究者
Denise Herzog
Associate Professor
Université de Montréal