Clinical Study Comparing the Efficacy of Transbuccal Paracetamol 125 mg Versus Paracetamol Injection 1g in Slow Infusion IV in Patients With Acute Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Pain score measured by visual analogue scale
研究概览
简要总结
This is a clinical study that aims to investigate and compare the efficacy of transbuccal paracetamol 125 mg with that of paracetamol 1g administered intravenously in patients with acute pain of moderate intensity accepted to emergency room following a minor trauma of the lower limbs and/or superiors. To this end, several pain scoring will be performed using a visual analogue scale (VAS) at various times after drug administration.
详细描述
This is a clinical study that aims to investigate and compare the efficacy of transbuccal paracetamol 125 mg with that of paracetamol 1g administered intravenously in patients with acute pain of moderate intensity accepted to emergency room following a minor trauma of the lower limbs and/or superiors. To this end, several pain scoring will be performed using a visual analogue scale (VAS) at various times after drug administration.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient admitted to emergency departments with trauma of upper or lower limbs (sprains, muscle contusions,…) associated with intensity moderate of acute pain (VAS between 4 and 6) which require infusion IV of paracetamol 1g.
- •Patient takes any chronic treatment which considered incompatible with study.
- •Patient between 18 and
- •Male or female.
- •Sufficient cooperation and understanding to comply to the requirements of study.
- •Acceptance to give a written consent.
- •Affiliation at system of French social security.
- •Inscription or acceptation of inscription at national register of voluntaries participant at research
排除标准
- •Against paracetamol-indication: hypersensitivity known at paracétamol, antecedent hepatitis B or C, severe renal insufficiency and liver failure.
- •Patient with medical or surgical antecedents.
- •Patient with progressive disease at balance of inclusion.
- •Alcoholism suspicion or toxicomany at intake.
- •Patient who presents any inflammation or ulcerative pathology about buccal mucosa.
- •Patient who refuses to ingest alcohol for personal reasons.
- •Woman in childbearing age not using effective contraceptive method, pregnant or lactating woman.
- •Patient who participated in another clinical trial, located in exclusion period or received benefits > 4500 euros during 12 months before the beginning of trial.
- •Patient with cooperation and understanding insufficiency to comply to the requirements of protocol
- •Patient with social protection
- •No affiliation at system of French social security
研究组 & 干预措施
transbuccal paracetamol 125 mg
This is a clinical study that aims to investigate and compare the efficacy of transbuccal paracetamol 125 mg with that of paracetamol 1g administered intravenously in patients with acute pain of moderate intensity accepted to emergency room following a minor trauma of the lower limbs and/or superiors. To this end, several pain scoring will be performed using a visual analogue scale (VAS) at various times after drug administration.
干预措施: paracetamol (Drug)
placebo
This is a clinical study that aims to investigate and compare the efficacy of transbuccal paracetamol 125 mg with that of paracetamol 1g administered intravenously in patients with acute pain of moderate intensity accepted to emergency room following a minor trauma of the lower limbs and/or superiors. To this end, several pain scoring will be performed using a visual analogue scale (VAS) at various times after drug administration.
干预措施: Placebo (Drug)
结局指标
主要结局
Pain score measured by visual analogue scale
时间窗: at T0 + 120 minutes
次要结局
未报告次要终点