Different Analgesics Prior to IUD Insertion: Is There Any Evidence?
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- current pain level with IUD insertion and 15 minutes post procedure measured by the Visual Analogue Scale.
研究概览
简要总结
Different ways of reducing pain during IUD insertion have been explored. So a randomized study will be conducted to test their role
详细描述
A randomized clinical controlled trial of women undergoing IUD insertion. Participants in the study groups will be randomly assigned by labeled opaque envelopes to either1% lidocaine (Xylocaine 1%, Astra Zeneca, Egypt), misoprostol (Sigma, Egypt), naproxen (Naprosyn, Syntax, Egypt) or placebo tablets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients are considered eligible if:
- •they are alert oriented and co-operative to response to the visual analogue scale (VAS).
- •They will sign the informed consent to participate in the clinical trial before entering the study.
- •Willingness to be randomized and complete study questionnaires.
排除标准
- •Participants are excluded from participation if they are ineligible for an IUD by accepted criteria of our institution such as:
- •A lidocaine allergy
- •Copper allergy
- •Current cervicitis
- •Pelvic inflammatory disease (PID) within 3 months
- •Uterine anomalies
- •Pain medication within 6 hours before insertion
- •Misoprostol administration within 24 hour before insertion
- •History of cervical surgery and contraindication to study medications.
研究组 & 干预措施
lidocaine group
Group A will receive 10 ml 1% lidocaine (Xylocaine 1%, Astra Zeneca, Egypt) Para cervical block prior to insertion of IUD (injection sites at cervix-vaginal junction typically at 4 ,8 O'clock), Then 3 minutes waiting period between the administration of the Para cervical block and IUD insertion,
干预措施: Lidocaine (Drug)
misoprostol group
Group B will receive 400 mcg oral misoprostol (Sigma, Egypt) prior to IUD insertion
干预措施: oral misoprostol (Drug)
non steroid group
Group C will receive oral naproxen (Naprosyn, Syntax, Egypt) prior to IUD insertion
干预措施: naproxen (Drug)
placebo group
group D will receive placebo tablets.
干预措施: placebo (Other)
结局指标
主要结局
current pain level with IUD insertion and 15 minutes post procedure measured by the Visual Analogue Scale.
时间窗: 15 minutes
A Visual Analogue Scale is a measurement instrument that tries to measure a characteristic or attitude that is believed to range to across a continuum of values and can not easily to be directly measured. Subjects pain using a 10 point visual analogue scale (-+VAS, anchors: 0=non, 10 = worst imaginable). The participants were asked to mark their pre IUD insertion pain expectancies initially, then to mark their pain during different steps of IUD placement.
次要结局
未报告次要终点
研究者
mohamed maher
assistant professor
Al Hayat National Hospital