Intranasal Ketamine for Peripheral Venous Puncture in Pediatric Patients: A Randomized Double Blind and Placebo Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 主要终点
- Decreased venipuncture Time
研究概览
简要总结
Randomized clinical trial, controlled, double-blind, parallel two-arm.
详细描述
Randomized, double-blind, placebo controlled study conducted at the Clinical Hospital of Porto Alegre between November / 15 and August / 16. This study was approved by the Ethics Committee of the Institution. Participated children requiring venipuncture randomized in the intervention group who received the ketamine IN 4 mg/kg and placebo saline group. The groups were compared: Puncture time, ease the nurse to perform the procedure, adverse events, changes in vital signs and perception of the companion.
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
- 3 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children hospitalized in the Pediatric Inpatient Units, with the presence of legal guardian;
- •Aged 3 months to 12 years;
- •Requiring venipuncture independent research.
排除标准
- •Severe neurological sequelae;
- •Patients who need immediate venipuncture at risk;
- •Presence of active nosebleeds;
- •Patients using drugs sedative and analgesic continuos;
- •Children who have experienced clinical change with ketamine.
研究组 & 干预措施
Ketamine group
This group was used intranasal ketamine, syringes were made with 4 ml of the drug (50mg/ml), 1 randomized per patient. The validity stability and were 7 days after drawing the solution. The drug began to take effect in 10 minutes and lasted about 40 minutes.
干预措施: Ketamine (Drug)
Placebo Group
This group was used intranasal saline, syringes were made with 4 ml of liquid 1 per patient randomized. The validity stability and were 7 days after drawing the solution.
干预措施: Placebo (Drug)
结局指标
主要结局
Decreased venipuncture Time
时间窗: Expected 3 minutes difference between the 2 groups
次要结局
未报告次要终点