A Randomized Controlled Trial of Oral Acetaminophen for Analgesic Control After Transvaginal Oocyte Retrieval
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Median of Cumulative Pain Scores Up to 60 Minutes Post Procedure
研究概览
简要总结
Current standard of care is no pretreatment medications before the egg retrieval, and the investigators would like to evaluate if preoperative Tylenol improves procedure and post procedure pain control over the current practice (no pre-treatment). Specifically, this study will compare Tylenol with a placebo when given before retrieval procedures. The investigators believe that if Tylenol can offer better analgesic relief than no pretreatment medications, then it may reduce the amount of narcotics needed by patients during and after the procedure and contribute to better patient satisfaction. . This study will enroll 100 participants all from University of Alabama at Birmingham (UAB).
详细描述
The current standard of care for oocyte retrieval in IVF involves fentanyl, propofol, as well as oxycodone. However, there exists little data of alternatives to narcotic medications for analgesic purposes in oocyte retrieval procedures. A retrospective study published in 2013 showed potential for NSAID's, specifically ketorolac, to significantly improve pain scores in women undergoing oocyte retrieval. It was also shown that the use of these medications did not significantly alter pregnancy rate, live birth rate, or miscarriage rate in these patients. Few other studies have delved into the question of anesthetics for oocyte retrievals except a prospective study in 2006. This study shows that no significant difference in pregnancy rates of implantation occurs with the use of acetaminophen and diclofenac vs. acetaminophen alone if given post-operatively. However, pain was not measured in this study for either group. Therefore, it is clear that there exists limited data on the subject of analgesics used in oocyte retrievals for in vitro fertilization and that more exploration into alternative medications is required to find the most effective and least harmful option.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •English Speaking
- •Undergoing Transvaginal Oocyte Retrieval Procedure
排除标准
- •Acetaminophen allergy
- •Opioid dependency
研究组 & 干预措施
Control
Control group participants will receive unlabelled 2 non-active placebo tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure.
干预措施: placebo (Drug)
Experimental
Experimental group participants will receive 2 acetaminophen 500mg tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure.
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Median of Cumulative Pain Scores Up to 60 Minutes Post Procedure
时间窗: 60 minutes post-procedure
Median of cumulative pain scores (measured on a visual analog scale from 0-10 where 0=no pain and 10=worst pain) taken during the recovery period (15, 30, 45, and 60 minutes post procedure)
Median of Cumulative Pain Scores Up to 24 Hours Post Procedure
时间窗: 24-hours post-procedure
Median Pain score (measured on a visual analog scale from 0-10 where 0=no pain and 10=worst pain) taken at 24-hours post-procedure
次要结局
- Number of Participants With Use of Analgesics in the First 24 Hours After Discharge(60-minutes post-procedure to 24-hours after procedure)
- Number of Participants With Use of Analgesics up to 60 Minutes Post Procedure(60-minutes post-procedure)
研究者
Deidre D Gunn, MD
Principal Investigator
University of Alabama at Birmingham