A Randomised, Double - Blind, Placebo Controlled Clinical Trial to Assess the Efficacy of the Homeopathic Medication TRAUMEEL S in Controlling Post-operative Pain After Fracture of Neck of Femur
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Cumulative 48-hour postoperative morphine consumption
研究概览
简要总结
We hypothesize that Traumeel S is more effective than placebo in reducing 48-hour mean cumulative morphine consumption in patients scheduled for surgical correction of fracture of neck of hip.
224 patients, meeting all inclusion and none of exclusion criteria, will be enrolled in the trial. Patients will be randomized to receive either intraoperative injection and post operative oral Traumeel S Tablets or placebo injection (normal saline) and indistinguishable oral placebo tablets. Baseline measurements of relevant outcome measures will taken preoperatively. Immediately after surgery, patients will receive an initial dose of morphine of 0.1mg/kg body weight. Patients will take the oral study medication for 21 days. Every four hours after surgery, patients will be asked to grade their pain on an NRS. Subsequent doses of morphine will be calculated based upon the patient's weight and current NRS, according to a preplanned scheme. Patients will be permitted to request additional morphine, beyond their calculated dose.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of either sex undergoing surgical correction of unilateral fracture of neck of hip.
- •Age over 18 years.
- •Signature upon informed consent form
排除标准
- •Participation in another clinical trial within 4 weeks prior to enrollment.
- •Refused to give verbal consent to the telephone interviews
- •Impossibility to be reached during the 14-17 days post operative
- •Inability to comply with the study protocol for any other reason
- •Previous major surgical procedure on ipsilateral hip.
- •Current use of analgesics for any other reason.
- •A history of chronic pain syndrome.
- •Abused legal or illicit drug use.
- •Hypersensitivity to botanicals of the Compositae family
- •Known sensitivity to paracetamol, codeine or tramadol.
研究组 & 干预措施
A
TRAUMEEL S
干预措施: Traumeel S (Drug)
B
placebo remedy
干预措施: Placebo remedy (Drug)
结局指标
主要结局
Cumulative 48-hour postoperative morphine consumption
时间窗: 48h
次要结局
- Secondary: AUC of NRS scores for first 48 hrs.;(48h)
- AUC of NRS scores for days 14-17.;(17d)
- Composite measure of pain intensity and opiate consumption;(17d)
- Number of primary oral analgesic tablets ingested between days 14-17;(17d)
- ESR and hs-CPR at three and six days and six weeks;(42d)
- IL-6 at three and six days;(6d)
- Post operative blood loss;(48h)
- WOMAC;(17d)
- Safety of post operative treatment(17d)