Fast-Release Orodispersible Tramadol Tablet (Tradonal Odis®) as Analgesia for Hysterosalpingography : a Randomized, Controlled, Double Blinded Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- VAS at the six different assessment points
研究概览
简要总结
This study evaluates the analgetic effects of the fast-release orodispersible tramadol tablet.
Tramadol acts through a weak affinity for μ receptors and secondly by inhibiting noradrenaline and serotonin neuronal reuptake. It has been used since the 1970s by over 50 million people for the treatment of acute and chronic pain. The orodispersible Tramadol tablet is a new galenic form and is available on the Belgian market for the last three years. Pregastric absorption leads to a quicker onset of action.
So far, evidence shows that pain during and immediately after the Hysterosalpingography (HSG) procedure is only significantly reduced by IV opioid analgesia. This study evaluates the analgetic potential of an orodispersible opioid tablet. This tablet disintegrates rapidly (in around 20-30 seconds) and may be taken without water. Its abuse potential is very low and its respiratory depressant effect is negligible.
详细描述
Four arm prospective randomized double blinded trial
Patients that need a HSG as part of their diagnostic work-up and are eligible for randomization are counseled about possible participation. After signing the informed consent patients will be randomized in one of the following four groups:
Group 1: Fast-release Orodispersible Tramadol Tablet + metal cannula Group 2: Placebo + metal cannula Group 3: Fast-release Orodispersible Tramadol Tablet + balloon catheter Group 4: Placebo + balloon catheter
Tablets are administered 30 min before the procedure
Primary Endpoint:
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •> 18 and < 45 years
- •Written informed consent
排除标准
- •Contra-indication to tramadol, morphine or to other opioids
- •Concomitant use of MAO inhibitors or use less than 2 weeks prior to procedure
- •Use of any other CNS-acting drug
- •Contra-indication to radio-contrast medium (allergy)
- •Patient already taking analgetics
- •History of cervical stenosis
- •Presence of pelvic inflammatory disease or any other condition causing pelvic pain
- •Clinical and/or laboratory evidence of any major disease
- •Pregnant or lactating
研究组 & 干预措施
Tramadol + Metal cannula
Fast-release Orodispersible Tramadol Tablet + Metal cannula
干预措施: Fast-release Orodispersible Tramadol Tablet (Tradonal odis®) (Drug)
Tramadol + Metal cannula
Fast-release Orodispersible Tramadol Tablet + Metal cannula
干预措施: Hysterosalpingography (HSG) (Procedure)
Placebo + Metal cannula
Placebo + Metal cannula
干预措施: Hysterosalpingography (HSG) (Procedure)
Placebo + Metal cannula
Placebo + Metal cannula
干预措施: Placebo (Drug)
Tramadol + Balloon
Fast-release Orodispersible Tramadol Tablet + balloon catheter
干预措施: Fast-release Orodispersible Tramadol Tablet (Tradonal odis®) (Drug)
Tramadol + Balloon
Fast-release Orodispersible Tramadol Tablet + balloon catheter
干预措施: Hysterosalpingography (HSG) (Procedure)
Placebo + Balloon
Placebo + balloon catheter
干预措施: Hysterosalpingography (HSG) (Procedure)
Placebo + Balloon
Placebo + balloon catheter
干预措施: Placebo (Drug)
结局指标
主要结局
VAS at the six different assessment points
时间窗: 24 hours
次要结局
- Adverse effects and complications(24 hours)