NCT01782846已完成4 期
Double Blind-randomized Study Comparing the Efficacy of Two Analgesia (Ixprim® and Dafalgan-Codeine®) , in the Emergency Unit.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 803
- 试验地点
- 1
- 主要终点
- pain improvement
研究概览
简要总结
Double-blind randomized study to compare the efficacy of two analgesic drugs(Ixprim®, Dafalgan-Codeine®) in the emergency unit.
The efficacy (relief of pain) would be assessed 2 hours after administration of one of the two drugs in a patient presented to the emergency unit with a moderate pain (4 to 6 on pain assessment score).
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of 18 - 75 years of age
- •Presented to the emergency unit of FOCH hospital
- •Complaining of moderate pain (4-6 on pain assessment scale) evaluated by the reception nurse
排除标准
- •Patient already had received another type 2 analgesia or already received one of the study drugs in the last 4 hours
- •pregnant or lactating females
- •Patient with one or more contraindication to one of the study drugs
- •Patients for whom the pain assessment scale can not be performed (unconscious, confused ...)
- •Patient cannot be included for legal reasons
- •Patient required urgent management
- •Patient for whom it is considered difficult to be reassessed 2 hours later
- •Patient unable to swallow
研究组 & 干预措施
Ixprim®
Active Comparator
2 capsules of Ixprim® given orally (1000 mg Paracetamol + 75 mg Tramadol)
干预措施: Ixprim® (Drug)
Dafalgan Codeine®
Active Comparator
Two capsules of Dafalgan Codeine® given orally (1000 mg Paracetamol + 46.8 mg Codeine)
干预措施: Dafalgan-Codeine® (Drug)
结局指标
主要结局
pain improvement
时间窗: 120 minutes
次要结局
未报告次要终点
研究者
研究点 (1)
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