Cost-effectiveness Analysis of Oral Paracetamol and Ibuprofen for Treating Pain After Soft Tissue Limb Injuries: Double-blind, Randomised Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 782
- 试验地点
- 1
- 主要终点
- analgesic efficacy both at rest and with movement
研究概览
简要总结
Background: Paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen are commonly used oral analgesics in emergency departments (ED) not only in Hong Kong but throughout the world. There are no large-scale (n>100), prospective, randomised studies comparing paracetamol with ibuprofen in the management of acute soft tissue injury.
As paracetamol is cheaper than most NSAIDs, may be as effective in the management of acute pain and possibly with fewer adverse effects, a large-scale, randomised, controlled trial is needed to answer questions of relative analgesic efficacy, safety and cost-effectiveness. Previous comparative studies on NSAIDS have been done in this unit and have suggested equivalence between two NSAIDs and paracetamol, but numbers were small and drug doses were modest.
Objective: To compare the efficacy, safety and cost between oral ibuprofen and paracetamol in pain control for acute soft tissue injuries in an ED setting
Design: Prospective, double-blind, randomised controlled trial with three arms: oral paracetamol with placebo; oral ibuprofen with placebo; paracetamol and ibuprofen in combination
Participants: 783 subjects having sustained isolated soft tissue limb injury without significant fracture presenting to the ED of Prince of Wales Hospital
Main outcome measures: Pain relief profiles of paracetamol, ibuprofen and the combination of both; adverse effect profiles of paracetamol, ibuprofen and the combination of both; overall cost effectiveness of paracetamol, ibuprofen and the combination of both from the perspective of the healthcare provider
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients >16 years presenting to the ED with isolated soft tissue injury without significant fracture
- •between 9am to 5pm, Monday to Friday,
排除标准
- •History of :
- •peptic ulceration or hemorrhage
- •recent anticoagulation
- •pregnancy
- •adverse reaction to paracetamol or ibuprofen
- •renal or cardiac failure
- •hepatic problems
- •rectal bleeding
- •chronic NSAID consumption
- •chronic obstructive pulmonary disease
- •chronic pain syndromes
- •prior treatment with analgesia for the same injury
- •physical, visual or cognitive impairment making use of the visual analogue scale unreliable
研究组 & 干预措施
1
干预措施: Paracetamol (Drug)
1
干预措施: Ibuprofen placebo (Drug)
2
干预措施: Ibuprofen (Drug)
2
干预措施: Paracetamol Placebo (Drug)
3
干预措施: Paracetamol (Drug)
3
干预措施: Ibuprofen (Drug)
结局指标
主要结局
analgesic efficacy both at rest and with movement
时间窗: 72 hours
次要结局
- presence, frequency and duration of adverse effects; cost-effectiveness analysis; patient satisfaction with analgesia(30 days)
研究者
Colin Graham
Professor
Chinese University of Hong Kong