跳至主要内容
临床试验/NCT03732469
NCT03732469终止4 期

Administration of Rectal Acetaminophen During Oocyte Retrievals Reduces Post-Operative Opioid Utilization in Fertility Patients

University of South Florida1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2019年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
4
试验地点
1
主要终点
Proportion of prescribed Tylenol with Codeine (Tylenol #3) utilized

研究概览

简要总结

The primary aim of this study is to evaluate the administration of rectal acetaminophen to current and standard anesthesia and analgesia protocol in oocyte retrievals would reduce postoperative utilization of opioids (Tylenol with codeine) in fertility patients.

详细描述

As the opioid epidemic shows no sign of abating, this national crisis deserves careful attention from all medical subspecialties. This includes reproductive endocrinology and infertility (REI), where opioids are primarily utilized for intraoperative and postoperative pain management for outpatient procedures such as oocyte retrievals, operative hysteroscopy, and laparoscopic myomectomy. The purpose of this study is to evaluate whether the administration of rectal acetaminophen in addition to the current, standard anesthesia and analgesia protocol in oocyte retrievals can help decrease utilization of prescribed opioid at home following oocyte retrieval. Rectal acetaminophen will be used rather than conventional IV acetaminophen because of the lack of access to IV acetaminophen at the study institution. Rectal acetaminophen is appealing because it is cheap, readily available in most medical centers and there is the potential for increased analgesic benefit due to the proximity to the vaginal and ovarian tissue, as well as the possible benefit from the partial avoidance of hepatic first-pass metabolism. This trial has the potential to provide practice-changing clinical information to the field of REI. The information gained can even translate to other ambulatory procedures and guide clinical practice. The investigators hypothesize that participants given rectal acetaminophen in addition to standard anesthesia/analgesia at the end of their oocyte retrieval will use less amount of prescribed Tylenol with codeine 3 days after discharge from the surgery center compared those receiving standard anesthesia/analgesia for oocyte retrieval.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 56 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Any female patient undergoing oocyte retrieval by transvaginal ultrasound-guided ovarian puncture

排除标准

  • Patients with chronic pain conditions such as fibromyalgia and sickle cell anemia.
  • Patient with BMI greater than 40
  • Patients that required general endotracheal intubation anesthesia in prior oocyte retrieval
  • Patients with documented allergic reaction to acetaminophen
  • Patient with contra-indication to the use of acetaminophen (liver disease)
  • Patients with a history of past or current alcohol, drug or opioid abuse
  • Patients with ulcerative colitis, Crohn's disease, or severe rectal hemorrhoids

研究组 & 干预措施

Fentanyl/propofol + acetaminophen

Experimental

In addition to the weight-based intraoperative IV dose of propofol and fentanyl per standard TGH Anesthesiology protocol, one dose of 1300 mg of solid base rectal acetaminophen suppository (2 suppositories) will be administered at the end of oocyte retrieval.

干预措施: Acetaminophen (Drug)

Fentanyl/propofol + acetaminophen

Experimental

In addition to the weight-based intraoperative IV dose of propofol and fentanyl per standard TGH Anesthesiology protocol, one dose of 1300 mg of solid base rectal acetaminophen suppository (2 suppositories) will be administered at the end of oocyte retrieval.

干预措施: Fentanyl (Drug)

Fentanyl/propofol + acetaminophen

Experimental

In addition to the weight-based intraoperative IV dose of propofol and fentanyl per standard TGH Anesthesiology protocol, one dose of 1300 mg of solid base rectal acetaminophen suppository (2 suppositories) will be administered at the end of oocyte retrieval.

干预措施: Propofol (Drug)

Fentanyl/propofol only

Active Comparator

Participants in this arm will receive the weight-based intraoperative IV dose of propofol and fentanyl per standard TGH Anesthesiology protocol.

干预措施: Fentanyl (Drug)

Fentanyl/propofol only

Active Comparator

Participants in this arm will receive the weight-based intraoperative IV dose of propofol and fentanyl per standard TGH Anesthesiology protocol.

干预措施: Propofol (Drug)

结局指标

主要结局

Proportion of prescribed Tylenol with Codeine (Tylenol #3) utilized

时间窗: 72 hours following oocyte retrieval

The proportion of prescribed Tylenol with Codeine (Tylenol #3) utilized 72 hours postoperatively will be assessed by telephone encounter. A total of 10 tablets of Tylenol #3 will be prescribed to each participant. Fewer Tylenol #3 used at the end of this time frame would indicate better outcome.

次要结局

  • Pain score in post-anesthesia care unit using the Visual Analog Scale(1-hour after oocyte retrieval)
  • 24-hour pain score using the Visual Analog Scale(24 hours after oocyte retrieval)
  • 48-hour pain score using the Visual Analog Scale measuring pain(48 hours after oocyte retrieval)
  • 72-hour pain score using the Visual Analog Scale measuring pain(72 hours after oocyte retrieval)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验