Fast-release Orodispersible Tramadol as Analgesia in Termination of Pregnancy by Vacuum Aspiration.
试验速览
- 阶段
- 4 期
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Will fast-release orodispersible tramadol reduce the pain (VAS) significantly in a vacuum aspiration procedure in this placebo-controlled trial.
研究概览
简要总结
If a termination of pregnancy procedure is performed by vacuum aspiration our patients receive a paracervical block. Nevertheless these patients are not free of pain. We randomised our patients: one group will receive additional orodispersible tramadol, the other group will receive a placebo.
详细描述
Patients were administered either 50 mg of fast-release orodispersible tramadol (Meda Pharma, Brussels, Belgium) or placebo 30 min before the procedure. Both, patient and gynecologist were blinded.
Patients underwent the following procedure: a sterile bivalve speculum was introduced into the vagina, then cervix and vagina were washed with an antiseptic solution. The cervix was grasped with a tenaculum and straigthened. A paracervical block was achieved using a 27-gauge spinal needle. Lidocaine was injected and distributed equally around the cervicovaginal junction at 1, 5, 7 and 11 o'clock. The suction curettage was accomplished through the following steps: the cervix was dilated, in function of the gestation, to Hagar number 5 to 11 (Aesculap, Ag and Co. KG, Tuttlingen, Germany); The uterine depth was measured using a hysterometry; suction curettage was performed by using plastic canula (Luneau Sas, France) and a classic suction pump (AMEDA Egnell SA, Switserland). The patients were observed for 2 hours after the curettage procedure.
Patients were asked to rate the pain during different steps of the procedure.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •- Patients above 18 ans.
- •Non desired pregnancy.
- •Non evolutive pregnancy.
- •Pregnancy < or = 14 weeks of amenorrhea.
排除标准
- •- Interruption of pregnancy due to medical reasons
- •Patient already included in this study
- •Intolerance for Tradonal Odis 50mg
研究组 & 干预措施
Fast release oro-dispersible tramadol
This group receives a fast release oro-dispersible tramadol 30 minutes before the vacuum aspiration procedure. A paracervical block with a 27-gauge spinal needle with lidocaine will be injected at the the start of the procedure.
Intervention: use of fast release oro dispersible tramadol 50 mg
干预措施: fast release oro dispersible tramadol 50 mg (Drug)
结局指标
主要结局
Will fast-release orodispersible tramadol reduce the pain (VAS) significantly in a vacuum aspiration procedure in this placebo-controlled trial.
时间窗: 6 to 8 month to include all patients
次要结局
未报告次要终点