Rescue Emetic Therapy for Children Having Elective Therapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Primary-Incidence of POV after rescue antiemetic in PACU, car ride home, day of surgery, and POD #1 and 2
研究概览
简要总结
To compare ondansetron, metoclopramide, diphenhydramine, and placebo in order to determine which anti-emetic is most efficacious as a "rescue therapy" for pediatric patients ages 3-18 who have post-operative vomiting after a standardized prophylactic regimen of ondansetron and dexamethasone. We hypothesize that anti-emetics with a different mechanism of action than the prophylactic regimen will be the most effective "rescue therapy" in children having surgery in an ambulatory surgery center.
- Problem: Despite commonly-used anti-emetics for prophylaxis, some children still go on to develop post-operative vomiting (POV).
Goal: To determine which anti-emetic--ondansetron, metoclopramide, diphenhydramine, or placebo--is most efficacious for pediatric patients in this situation. 2. Hypothesis: Anti-emetic medications that have a different mechanism of action than the prophylactic regimen will be the most efficacious "rescue therapy." 3. Hypothesis: Metoclopramide at the dose of 0.5 mg/kg (max dose 20 mg) will be more effective than ondansetron, diphenhydramine, or placebo as "rescue therapy."
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pediatric patients 3-17 years old
- •Patients scheduled for tonsillectomy and/or adenoidectomy (with and without myringotomy) , or dental restoration,
- •Patients receiving a general anesthetic (inhaled agent without nitrous oxide) with POV prophylaxis with two agents (ondansetron and dexamethasone)
- •Post operative vomiting in PACU or second stage recovery requiring antiemetic rescue.
排除标准
- •Vomiting in the past 24 hours or antiemetics in previous 24 hours
- •Allergy or sensitivity to ondansetron, dexamethasone, metoclopramide, or diphenhydramine
- •Patients with diabetes
- •Patients with seizures
- •Patients receiving a benzodiazepine premedication
研究组 & 干预措施
Metoclopramide
rescue emetic therapy
干预措施: Metaclopramide (Drug)
Ondansetron
Rescue emetic therapy
干预措施: Ondansetron (Drug)
Diphenhydramine
Rescue emetic therapy
干预措施: diphenhydramine (Drug)
Saline
Placebo
干预措施: Saline (Drug)
结局指标
主要结局
Primary-Incidence of POV after rescue antiemetic in PACU, car ride home, day of surgery, and POD #1 and 2
时间窗: 48 hrs
次要结局
- Secondary - a. Discharge times(48 hrs)
- Adverse events (headaches, sedation, dystonic reaction, dry mouth)(48 hrs)
- POV risk factors. age, personal or family history of PONV, history of motion sickness, personal or family history of smoking(48 hrs)
研究者
Franklyn Cladis
Associate Professor
University of Pittsburgh