A Double-blind Placebo-controlled Randomized Controlled Trial (RCT) of 3ml Methoxyflurane for Intrauterine Device (IUD) Insertion and Endometrial Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Global pain score
研究概览
简要总结
The aim of this study is to determine if 3ml of inhaled Methoxyflurane, in the form of a Penthrox inhaler, reduces pain during IUD insertion and/or endometrial biopsy. The proposed study is a double-blind, placebo-controlled RCT.
Each participant will be randomly assigned to one of two arms:
- Intervention (3ml of Methoxyflurane via a Penthrox inhaler)
- Placebo (3ml of normal saline via an identical placebo Penthrox inhaler)
The primary outcome is global pain score, which will be patient-reported by the 100 mm Visual Analogue Scale (VAS) 5-minutes following the procedure (endometrial biopsy or IUD insertion).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The research coordinator (who is not involved in direct patient care) will open the allocation envelopes without the presence of the participant or the provider. They will prepare the Penthrox inhalers with either 3 mL methoxyflurane or 3 mL normal saline with a few drops of methoxyflurane on the outside of the inhaler to maintain blinding (as methoxyflurane has a distinct smell). The research coordinator will label each Penthrox inhaler with the study ID number.
The provider (who is blinded to the study) will enter the patient room with the procedure tray and the Penthrox inhaler. They will instruct the patient to inhale for 10 breaths with their finger covering the dilutor hole of the Penthrox inhaler. Once the patient has taken 10 breaths, the research assistant will start a timer for 5 minutes. The research assistant will inform the OB-GYN once the 5 minutes have passed and at that point the OB-GYN will start the procedure. All data will remain blinded until data analysis.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
3ml of Methoxyflurane
3ml of Methoxyflurane via a Penthrox inhaler
干预措施: Methoxyflurane - Penthrox (Drug)
3ml of normal saline
3ml of normal saline via an identical placebo Penthrox inhaler
干预措施: Placebo Penthrox inhaler (Other)
结局指标
主要结局
Global pain score
时间窗: 5-minutes following the completion of the procedure
Patient reported pain by the 100 mm Visual Analogue Scale (VAS), minimum value 0 (no pain at all) and maximum value 100 (worst pain imaginable), higher scores indicate greater pain intensity.
次要结局
- Pain scores during procedure(During the procedure)
- Immediate complications and side effects(Immediately after the completion of the procedure)
- Difficulty for provider to complete the procedure(Immediately after the completion of the procedure)
- Length of time for procedure completion(During the procedure)
- Patient satisfaction(Immediately after the completion of the procedure)
- Patient Satisfaction(Immediately after the completion of the procedure)
研究者
Mara Sobel
Principal Investigator (Dr.)
Mount Sinai Hospital, Canada