Role of Prophylactic Metoclopramide With Tramadol in Trauma Patients: A Randomised, Double Blind Placebo Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 191
- 试验地点
- 1
- 主要终点
- Nausea severity scale
研究概览
简要总结
Tramadol is widely used as analgesic in trauma patients. However, it causes side effects, most notably nausea and vomiting. This study aim to determine the role of prophylactic metoclopramide in preventing tramadol induced nausea and vomiting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The study drugs were prepared under sterile conditions by a pharmacist independent to the study and kept in packs.The patients recruited were randomized to receive one of the study packs. The study pack were numbered by the pharmacist, who used a computer-generated random number sequence to assign treatment allocations. The allocation list was kept by the pharmacist. Treatment allocations were revealed only after study completion, when all outcome measurements had been performed and recorded by the investigator in the study database.
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 aged 18 years or older on day of presentation to ETD SGH
- •Sustained from traumatic injuries of extremities (Fracture of hand & wrist, radius, ulna, humerus, femur, tibia, fibula and/or foot & ankle; laceration wounds of extremities; soft tissue injury)
- •Patient who is able to give consent
排除标准
- •Known allergy to metoclopramide
- •Concurrently taking medication with anti-emetic effect, including antihistamines, phenothiazines and dopamine antagonists.
- •A history of vomiting since time of injury
- •Patients who had already received tramadol or metoclopramide in the previous 8 hours prior to arrival at ETD
- •Below age of 18 on day of presentation, or patients who could not consent to the study
- •Any alteration in level of consciousness
- •Hemodynamic instability or primary diagnosis requiring time critical intervention
- •Pregnancy or lactation
- •History or known case of vertiginous disorder
- •Currently undergoing chemotherapy or radiotherapy
研究组 & 干预措施
Group 2
Intravenous tramadol 50mg + placebo (normal saline)
干预措施: Placebo (Drug)
Group 1
Intravenous tramadol 50mg + intravenous metoclopramide 10mg
干预措施: Tramadol (Drug)
Group 1
Intravenous tramadol 50mg + intravenous metoclopramide 10mg
干预措施: Metoclopramide (Drug)
Group 2
Intravenous tramadol 50mg + placebo (normal saline)
干预措施: Tramadol (Drug)
结局指标
主要结局
Nausea severity scale
时间窗: One hour
Change in rating of nausea severity on Visual Analogue Scale 60 minutes after administration of the study drugs. VAS is a standard 100mm line marked "no nausea" at the left end and "worst nausea imaginable" at the right end. Minimum clinically significant difference is defined for this study as 20 mm increment.
次要结局
- Vomiting(One hour)
研究者
Dr Choo Kim Hoon
Doctor
University of Malaya