Comparative Safety and Efficacy of Cervical Lidocaine-Prilocaine Cream Versus Glyceryl Trinitrate Cream on Pain Perception During Levonorgestrel- Intrauterine Device Insertion Among Nulliparous Women: a Randomized Double-blind Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 195
- 主要终点
- pain during LNG-IUD insertion
研究概览
简要总结
the aim of the present study is to compare safety and efficacy of cervical Lidocaine-Prilocaine cream versus glyceryl trinitrate cream on pain perception during levonorgestrel- intrauterine device insertion among nulliparous women: a randomized double-blind controlled trial
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •young and adolescent women requesting LNG-IUD insertion
排除标准
- •parous women and contraindications to LNG-IUD placement or to the study drugs.
研究组 & 干预措施
Lidocaine-Prilocaine cream
2 mL of the Lidocaine-Prilocaine cream will be placed on the anterior lip of the cervix by a Q-tip applicator, followed by 2 mL will be introduced in the cervical canal 7 minutes prior to IUD insertion
干预措施: Lidocaine-Prilocaine cream (Drug)
glyceryl trinitrate cream
2 mL of the glyceryl trinitrate cream will be placed on the anterior lip of the cervix by a Q-tip applicator, followed by 2 mL will be introduced in the cervical canal 7 minutes prior to IUD insertion
干预措施: glyceryl trinitrate cream (Drug)
placebo cream
2 mL of the placebo cream will be placed on the anterior lip of the cervix by a Q-tip applicator, followed by 2 mL will be introduced in the cervical canal 7 minutes prior to IUD insertion
干预措施: placebo cream (Drug)
结局指标
主要结局
pain during LNG-IUD insertion
时间窗: 5 minutes
pain during LNG-IUD insertion evaluated by 10 cm Visual analog scale where 0=no pain and 10=worst pain imaginable
次要结局
- duration of the procedure(10 minutes)
研究者
Ahmed Samy aly ashour
assistant professor obstetrics and gynecology
Cairo University