Comparison Between the Analgesic Affects of Tramadol® and "Verbal Anesthesia" on Pain Management Associated With the Insertion of Jaydess® in Nulliparous Women
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 主要终点
- Evaluation of pre-insertion therapy (oral analgesia and oral Tramadol) as pain management during insertion of Jaydess measured on a VAS (0-100 mm).
研究概览
简要总结
A multicenter prospective interventional comparative study that investigate pain management during Jaydess insertion in nulliparous women that will be tested by the analgesic affects of oral tramadol or 'verbal anesthesia' on the patients.
详细描述
Most intrauterine contraception (IUC) insertions do not require pain management. However, small proportions of nulliparous women experience substantial pain that needs to be proactively managed No prophylactic pharmacological intervention has been adequately evaluated to support routine use for pain reduction during or after IUC insertion. Women's anxiety about the procedure may contribute to higher levels of perceived pain, which highlights the importance of counselling, and creating a trustworthy, unhurried and professional atmosphere in which the experience of the provider also has a major role; a situation frequently referred to as 'verbal anaesthesia'.
It has been proven in the past that the use of oral Tramadol can reduce the pain in the insertion.
In the study investigators will compare the analgesic affects of oral Tramadol and verbal anesthesia on pain relief during Jaydess insertion in nulliparous women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Nulliparous women aged 18-48 years, interested in a long acting, reversible contraception method. Each read and signed the informed consent.
排除标准
- •Women suffering from:
- •Acute or recurrent pelvic inflammatory disease.
- •Acute cervicitis or acute Vaginitis.
- •Current cervical intraepithelial lesion.
- •Current any genital malignancy.
- •Progesterone hypersensitivity.
- •progesterone-sensitive tumours (e.g. breast tumours).
- •Abnormal vaginal bleeding.
- •Congenital or acquired uterine anomaly.
- •Distorted uterine cavity e.g. fibroid or polyp.
- •Impaired liver functions, or liver tumour.
- •Known hypersensitivity to the active substance or to any of the excipients of Jaydess.
- •Contraindications to Tramadol according to approved product information:
- •In hypersensitivity to tramadol or any of the excipients.
- •In patients who are receiving monoamine oxidase inhibitors or within 2 weeks (14 days) of their withdrawal.
- •In patients with epilepsy not adequately controlled by treatment.
- •Vaginismus.
研究组 & 干预措施
oral tramadol
Patients will receive oral Tramadol 50 mg capsules (n=50)' . After an hour, Jaydess intrauterine device will be inserted.
干预措施: Tramadol (Drug)
oral tramadol
Patients will receive oral Tramadol 50 mg capsules (n=50)' . After an hour, Jaydess intrauterine device will be inserted.
干预措施: Jaydess (Device)
verbal anesthesia
'verbal anesthesia' (n=50) After an hour, Jaydess intrauterine device will be inserted
干预措施: Verbal anesthesia (Behavioral)
verbal anesthesia
'verbal anesthesia' (n=50) After an hour, Jaydess intrauterine device will be inserted
干预措施: Jaydess (Device)
结局指标
主要结局
Evaluation of pre-insertion therapy (oral analgesia and oral Tramadol) as pain management during insertion of Jaydess measured on a VAS (0-100 mm).
时间窗: Day of insertion
The primary outcome will be the patient evaluation of pain during the procedure. The patient will be asked to assess the pain according to VAS scale (10-100 mm) 10 minutes after the insertion of Jaydess intrauterine device.
次要结局
- Evaluation of pain during menstruation one month after the insertion of Jaydess intrauterine device(one month after insertion)
- Evaluation of pain during menstruation six month after the insertion of Jaydess(six month after insertion)
- Evaluation of the amount of bleeding during menstruation six month after the insertion of Jaydess intrauterine device(six month after insertion)
- Evaluation of the amount of bleeding during menstruation one month after the insertion of Jaydess intrauterine device(one month after insertion)