Oral Versus Intravenous Acetaminophen for Postoperative Pain Management After Oocyte Retrieval Procedure. A Double Blinded, Placebo Controlled, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- postoperative pain control
研究概览
简要总结
The investigators are going to study the difference in postoperative pain control after administration of oral versus intravenous formulation of acetaminophen
详细描述
Oocyte retrieval is an outpatient procedure that is a routine surgical intervention in the process of assisted reproductive technologies and oocyte banking. The perioperative pain control is achieved with multidrug regimen including intraoperative opioid medication and perioperative administration of oral or intravenous acetaminophen. This medication is more commonly known as Tylenol. Intravenous formulation of this medication is several fold more expensive and the data for perioperative pain control is mixed on the equivalence of pain control with intravenous versus oral acetaminophen in other fields. Currently there is no accepted standard of care and the two formulations are used interchangeably depending on primary physician's preference. We are conducting an equivalence placebo controlled randomized clinical trial to assess the difference in efficacy of these two formulations
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Female, aged 18-45
- •Ability to take oral medication and be willing to adhere to the study intervention regimen
排除标准
- •Known clinically significant liver disfunction
- •Known allergic reactions to components of acetaminophen such as angioedema, anaphylaxis or other
- •Known current substance use disorder
- •Chronic pain syndrome
- •Weight less than 50 kg
研究组 & 干预措施
Oral acetaminophen group
the subjects in this group will receive 1000 mg oral acetaminophen 30-45min prior to oocyte retrieval
干预措施: acetaminophen (Drug)
IV acetaminophen group
the subjects in this group will receive 1000 mg IV acetaminophen formulation intraoperatively
干预措施: acetaminophen (Drug)
结局指标
主要结局
postoperative pain control
时间窗: 24-48 hours
To compare the efficacy of oral versus IV formulation of acetaminophen for controlling perioperative pain after oocyte retrieval procedure. To assess the pain level, Visual Analog Scale(VAS) score will be utilize with the minimum number 0 representing no pain and maximum number of 10 representing the highest imaginable pain level.
次要结局
- Duration of postoperative recovery(variable ~1-3 hours)