Paracetamol Vs Paracetamol-Caffeine Association Vs Paracetamol-Codeine Association in the Management of Post Traumatic Pain in Emergencies
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Delta Numerical Rating Scale (NRS) ( From 0 to 10 )
研究概览
简要总结
The purpose of this study is to:
Compare the effect of paracetamol alone against Paracetamol+Codeine association against the association of paracetamol + Cafeine in the treatment of post-traumatic acute pain of the limbs.
详细描述
At admission to the emergency department, patients with acute post-traumatic pain will be included, regardless of their initial NRS .These patients will receive the necessary care for their injury (icing, reduction, immobilization, local care, sutures), then went home with a medical prescription and an outpatient appointment .
At discharge and after obtaining their signed consent . All patients included will be randomized according to a numerical randomization table ( assigned in a 1:1:1 ratio) into 3 groups ( As a treatment for their post traumatic pain at discharge for 7 days ) :
- Group 1: Paracetamol group who will receive paracetamol ( 1000 mg) : one pill 3 times a day for 7 days .
- Group 2: Paracetamol-codeine group who will receive an association of 500 mg of Paracetamol and 30 mg of codeine : one pill twice a day for 7 days .
- Group 3: Paracetamol-cafeine group who will receive an association of 500 mg of Paracetamol and 65 mg of cafeine : one pill 3 times a day for 7 days .
For all patients included in the study, demographic and clinical data will be collected by the physician or investigator and recorded on a pre-established form.
The demographic data recorded on each patient's chart were as follows: Age, sex, origin and personal pathological history:
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
- Single (Participant)
盲法说明
study medications consists of a randomly sequence generated numbers.
patients and the research associate who collected the outcome data are blinded from the study group
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
- •Age :18 years or older
- •Patients presented to the emergency department with acute post-traumatic pain and residual pain at rest and/or on movement with a numerical pain rating scale (NRS) > 3/10 on discharge.
- •They all signed a written consent form.
- •Exclusion criteria:
- •Self-mutilation
- •Severe acute trauma that may require hospitalization
- •Open or complicated fracture requiring surgical management
- •Regular use of analgesics
- •Any known allergy to paracetamol, caffeine or codeine
- •Asthma and acute/chronic respiratory insufficiency
- •Severe renal insufficiency (creatinine Cl<30 ml/min)
- •Pregnant/lactating women
- •Hepatic cirrhosis.
- •Refusal, incapacity or difficulties to consent or to communicate
排除标准
- 未提供
研究组 & 干预措施
Paracétamol Group
In each study population, the patient will be assigned to one of three treatments (Paracetamol Group or Paracetamol Codéine Group or Paracétamol Caféine Group) .
In Paracetamol group , the patients will receive a pill containing 1000 mg of paracetamol 3 times a day for 7 days .
Paracétamol 1000 mg : 1 pill *3 / day
干预措施: Paracetamol (Drug)
Paracétamol Codéine Group
In each study population, the patient will be assigned to one of three treatments (Paracetamol Group or Paracetamol Codéine Group or Paracetamol Caféine Group) .
In Paracetamol codéine group , the patients will receive a pill containing an association of paracetamol and codéine ( 500mg / 30mg ) 3 times a day for 7 days .
-Association of Paracétamol and Codéine ( 500mg / 30 mg) : 1 pill *2 /day
干预措施: Paracetamol Codeine (Drug)
Paracétamol Caféine Group
In each study population, the patient will be assigned to one of three treatments (Paracetamol Group or Paracetamol Codéine Group or Paracetamol Caféine Group) .
In Paracetamol caféine group , the patients will receive a pill containing an association of paracetamol and caféine ( 500mg / 65 mg ) 3 times a day for 7 days .
-Association of Paracétamol and Caféine ( 500mg / 65 mg) : 1 pill *3 /day
干预措施: Paracetamol caféine (Drug)
结局指标
主要结局
Delta Numerical Rating Scale (NRS) ( From 0 to 10 )
时间窗: 7 days from discharge
Treatment success is defined by the percentage of patients with a reduction in movement NRS at Day 7 discharge (Delta NRS ) ≥ 50% compared with NRS at emergency discharge. ( that mean a better outcome ) Delta NRS ( in movement)=(NRS (at discharge )-NRS (day7))/(NRS (at discharge )) X 100 .
次要结局
- Need for another analgesic medication or non-pharmacological analgesic intervention(7 days from discharge)
- Patient satisfaction assessed by Likert's verbal scale at 7 days(7 days from discharge)
- Appearance of side effects(7 days from discharge)
研究者
Pr. Semir Nouira
PROFESSOR
University of Monastir