A Prospective, Double-Blinded, Randomized Comparison of Intravenous Acetaminophen Versus Placebo in Children Undergoing Palatoplasty
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
This project is being used to assess the utility of intravenous acetaminophen in the pediatric population undergoing palate repairs. This study is a prospective randomized double blinded placebo controlled study. The investigators will have two arms, one group of patients will receive intravenous acetaminophen and one group that will receive a placebo at a total of four doses over 24 hours. The results of this study may affect the intraoperative anesthetic management as well as post-operative surgical management of this specific patient population. The goal is to determine the benefit of adding a non-opioid analgesic and hypothesizing that it may reduce the amount of narcotic consumption in the post anesthesia care unit as well as during the post-operative stay.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I or II
- •Presenting for repair of palatoplasty with Drs. Kirschner or Pearson
排除标准
- •ASA physical status > II
- •Underlying Syndrome
- •Significant co-morbid diseases (cardiac, pulmonary, neurological disease)
- •Patients having concomitant procedures (tonsillectomy, adenoidectomy, etc.)
研究组 & 干预措施
IV acetaminophen
IV acetaminophen administered q 4 hrs. for a total of 24 hrs.
干预措施: IV acetaminophen (Drug)
Placebo
Normal saline administered IV every 4 hrs. for a total of 24 hrs.
干预措施: Placebo (Drug)
结局指标
主要结局
Pain
时间窗: 24 hrs. post-op.
Pain scores will be assessed.
次要结局
- Opioid consumption(24 hrs. post-op)
研究者
Tarun Bhalla, MD
Clinical Assistant Professor
Nationwide Children's Hospital