Nitrous Oxide for Pain Management of First Trimester Surgical Abortion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Visual Analog Pain Score for Mean Maximum Procedural Pain
研究概览
简要总结
The purpose of this research is to study the effect of nitrous oxide on pain felt by women having a surgical termination at less than 11 weeks compared to pain felt by women receiving oral pain medications.
详细描述
This study has important implications in the field of pain management for surgical abortion. While NO is administered in some outpatient clinics for surgical abortion, its effect on pain has not been systematically studied in a randomized controlled trial in women undergoing first trimester surgical abortion under local/oral analgesia. Expanding pain management options for women undergoing abortion confers significant public health benefits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years old or older,
- •elective pregnancy termination at gestational age of less than 11 weeks,
- •speak English
- •candidate for an in-clinic procedure.
- •desire local anesthesia, ibuprofen, Vicodin and Ativan (the usual treatment in our clinic) for managing pain
排除标准
- •no medical problems preventing the use of nitrous oxide
- •no allergies to nitrous oxide, lidocaine, vasopressin, ibuprofen, Vicodin or Ativan
- •significant active upper respiratory infection
- •chronic obstructive pulmonary disease (COPD)
- •intoxication
- •use of street drugs
研究组 & 干预措施
Nitrous oxide administration
All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.
In addition, the Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously.
干预措施: Nitrous oxide administration (Other)
Standard care group
All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.
The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively.
结局指标
主要结局
Visual Analog Pain Score for Mean Maximum Procedural Pain
时间窗: Mean maximum pain experienced during the procedure and assessed 5 minutes after the procedure
The primary outcome of this study is to evaluate the difference in mean maximum pain experienced during the procedure between groups as assessed 5 minutes after the procedure is completed. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain
次要结局
- Visual Analog Scale Score for Baseline Pain(Baseline pain assessment on average within 30 minutes before procedure)
- Visual Analog Scale for Post-procedure Pain(Visual analog scale administered on average 20 minutes after procedure completed)
- Pain Management Satisfaction(Visual analog scale for satisfaction administered on average within 20 minutes after procedure completion.)
- Visual Analog Scale to Measure Anticipated Pain.(Anticipated pain assessed on average within 30 minutes before procedure)
研究者
Rameet Singh
Assistant Professor
University of New Mexico