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临床试验/ACTRN12620000810910
ACTRN12620000810910已完成4 期

Methoxyflurane for intrauterine device insertion in conscious patients, an open, single arm pilot study testing feasibility and medication acceptability

Royal Women's Hospital0 个研究点目标入组 30 人开始时间: 2020年8月13日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
30

研究概览

简要总结

While intrauterine devices (IUDs) are amongst the most reliable contraceptives, inserting them can be painful. We try to reduce this pain, but there is no strong evidence to support any of the medicines we currently use. Methoxyflurane is an inhaled pain relief which is commonly used for other surgical procedures when awake, but it has not yet been tested for its suitability for patients having gynaecological procedures. We performed a pilot study (a preliminary investigation) to ask 30 patients using methoxyflurane during IUD insertion about their experience. Our results are: 1. 97% of patients using methoxyflurane for IUD insertion felt that the using the drug was 'completely acceptable'. The remaining 3% said it was 'mostly acceptable. The same 97% said 'definitely yes' to whether they would want it in the same situation again. The remaining 3% said they were 'not sure'. 2. The average pain score of these patients when describing the 'worst pain' during the IUD insertion was 47/100. 3. The most common side effect was dizziness/light headedness and it was experienced by 27% of patients (9 people). 8/9 graded this symptom as mild, 1/9 called it moderate. Other side effects included euphoria in 18% (feeling high) or an irritated throat in 6%. In conclusion, methoxyflurane was highly acceptable for our 30 patients having IUDs inserted. It is now suitable for us to perform more studies to measure the degree of benefit.

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 75 Years(—)
性别
Female

入选标准

  • Adults undergoing outpatient intrauterine device insertion

排除标准

  • Non-English speaking, had any contraindication to an IUD insertion including cervical disease, pregnancy, abnormal bleeding of unknown diagnosis, active pelvic inflammatory disease, or had a history of renal disease/impairment, a known hypersensitivity to fluorinated anaesthetics, a history of cardiovascular instability including patients on beta-blockers (as may cause hypotension), and a history of possible adverse events (AEs)/intolerance to methoxyflurane

研究者

发起方
Royal Women's Hospital

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